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| ORIGINAL ARTICLE |
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| Year : 2023 | Volume
: 2
| Issue : 1 | Page : 18-23 |
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A prospective, randomized, interventional, comparative study between dexmedetomidine and propofol infusion for monitored anesthesia care during internal jugular vein chemoport insertion
Shahbaz Alam1, Nitesh Goel1, Nikhil Bhasin1, Shikha Modi2, Charanjeet Kaur1
1 Department of Anaesthesia, Rajiv Gandhi Cancer Institute, New Delhi, India
2 Department of Anaesthesia, MAMC, New Delhi, India
| Date of Submission | 03-Dec-2022 |
| Date of Decision | 10-Mar-2023 |
| Date of Acceptance | 28-Mar-2023 |
| Date of Web Publication | 25-May-2023 |
Correspondence Address:
Dr. Shahbaz Alam
Department of Anaesthesia, Rajiv Gandhi Cancer Institute, Sector-5, Rohini, New Delhi
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jica.jica_40_22
Background: Chemotherapy through peripheral intravenous cannula causes severe thrombophlebitis. Chemoport is a best and favorable alternative for the same. It is done under local infiltration along with monitored anesthesia care with sedation. However, due to the lack of any fixed regimen, overt to under sedation is more common. To maintain an effective, consistent, and continuous level of sedation, we compared dexmedetomidine and propofol infusion in patients requiring monitored anesthesia care (MAC) for chemoport insertion. Methodology: Fifty patients posted for internal jugular vein chemoport insertion were randomly distributed into two groups: the propofol group and dexmedetomidine group. In Group P-injection, propofol infusion started at 125 μg/kg/min. Once observer's OAAS score 3 was achieved, propofol infusion was reduced to 25–75 μg/kg/min, whereas in Group D-Injection, dexmedetomidine bolus infusion was started at 1 μg/kg for 10 min and followed by 0.3–0.7 μg/kg/h and titrated to an OAAS score of 3. Results: OAAS score 3 was achieved significantly earlier in the propofol group as compared to the dexmedetomidine group (3.12 ± 1.7 vs. 8.04 ± 2.07, respectively). We were also able to maintain the desired sedation level throughout the procedure. Satisfaction scores in both the groups were comparable and patients in both the groups were hemodynamically stable throughout the procedure. Conclusion: In the current study, we found that propofol infusion was better regarding early onset and maintenance of OAAS score 3 with no requirement of rescue sedation during the procedure. The hemodynamic parameters and satisfaction scores were comparable in both groups. Hence, we suggest the use of injection propofol infusion for MAC under sedation in a patient requiring internal jugular vein chemoport insertion when compared to dexmedetomidine.
Keywords: Bispectral index, dexmedetomidine, internal jugular port insertion, monitored anesthesia care, OAAS, propofol
How to cite this article:
Alam S, Goel N, Bhasin N, Modi S, Kaur C. A prospective, randomized, interventional, comparative study between dexmedetomidine and propofol infusion for monitored anesthesia care during internal jugular vein chemoport insertion. J Ind Coll Anesth 2023;2:18-23 |
How to cite this URL:
Alam S, Goel N, Bhasin N, Modi S, Kaur C. A prospective, randomized, interventional, comparative study between dexmedetomidine and propofol infusion for monitored anesthesia care during internal jugular vein chemoport insertion. J Ind Coll Anesth [serial online] 2023 [cited 2023 Sep 25];2:18-23. Available from: https://www.jicajournal.in//text.asp?2023/2/1/18/377601 |
| Introduction | |  |
With the incidence of cancer on the rise and chemotherapy becoming one of the major modalities of treatment, chemoport insertion is fast becoming a common procedure in cancer set-ups. It reduces the need for frequent intravenous cannulation, which is difficult and leads to thrombophlebitis in such patients. Chemoport insertion is a painful procedure which requires sedation and analgesia in the form of systemic drugs and local anesthetic infiltration. The pain and anxiety associated with chemoport insertion has often led to patients demanding general anesthesia. In most cancer institutes, the procedure is done under monitored anesthesia care using various anesthetic agents at bolus dose, but very few studies have been done regarding their response on patients during port insertion. Chang et al. did a study in which they used port site local anesthetic drug infiltration and oral lorazepam in patients posted for subclavian vein chemoport insertion and found that some patients may demand general anesthesia for the same procedure if required in future.[1] The other major study regarding anesthesia for chemoport insertion was done by Chun et al. who compared intravenous combinations of dexmedetomidine-ketamine with dexmedetomidine-midazolam-fentanyl and found that the latter was better.[2] It has been observed that a bolus dose of drug may cause overt to under sedation along with sudden change in hemodynamic parameters. Therefore, to reduce these abrupt changes, we chose to do the procedure with continuous infusion of sedative drugs. We aimed to compare dexmedetomidine and propofol infusion as a sedative as both of these are best known drugs for conscious sedation and none of them have been used in the past as an infusion for chemoport insertion.
| Methodology | | |
After approval from the Institutional Review board, this single centered, prospective, CTRI registered (CTRI/2022/06/043177), randomized controlled, interventional study was conducted from June 2022 to October 2022 at a tertiary care institute. Written informed consent was obtained from all the subjects participating in this interventional study. Patients with preexisting neuropsychiatric ailment, chronic kidney disease, substance abuse, coronary artery disease or on medication for chronic pain, having body mass index >35 were excluded from the study.
The sample size calculation was done based on previous study by Koruk et al. They found that verbal response time was 3.12 ± 1.7 min versus 19.2 ± 7.2 min, respectively.[3] Considering the 5% level of significance and 90% power of the test, the sample size was found 19 for each group. Assuming 20% dropouts, a sample size of 25 was taken in each group. After thorough preanesthetic evaluation, 50 American Society of Anesthesiologists (ASA) I and II patients of age group of 18–65 years, who demanded anesthesia services for internal jugular vein chemoport insertion were enrolled in this study. These 50 patients were equally and randomly (chit system) distributed into two groups: Group “P” (propofol infusion) and Group “D” (dexmedetomidine infusion) using chit system.
Monitored anesthesia care techniques were standardized in all patients with respect to basic drug administration and monitoring. All the patients were given anti-aspiration prophylaxis (tablet ranitidine 150 mg + tablet Granisetron 2 mg orally) the night before and on the morning of surgery. Inside the operation theater, standard ASA and bispectral index (BIS) monitoring were applied to all patients. An intravenous cannula was secured and intravenous balanced fluid was started at 2 ml/kg/h. Oxygen delivery through a facemask at 5 L/min was ensured in all the patients before giving the drugs. After placing a sand-bag below the shoulder for neck extension, the head was tilted to the opposite side of the chemoport insertion site and the patient was brought into Trendelenburg position (15° to 20°). Our primary objective was to compare the time to achieve an observer's assessment of alertness/sedation score (OAAS) of 3 in both the groups. Our secondary objectives were maintaining an OAAS score of 3 throughout the procedure, to assess the amount of rescue sedation used in both the groups, the satisfaction score of the surgeon, anesthesiologist and the patient, postoperative discharge score, and BIS assessment at an OAAS score of 3. Injection midazolam 1 mg iv and injection fentanyl 0.5 μg/kg iv bolus were then given to all the patients at the time of cleaning and draping of the port insertion site. Propofol/dexmedetomidine infusion was then started according to the groups allotted:
Group P: Propofol infusion started at 125 μg/kg/min. Once OAAS score 3 was achieved, the infusion was reduced to 25–75 μg/kg/min and titrated to maintain an OAAS score of 3.[4]
Group D: Dexmedetomidine bolus infusion started at 1 μg/kg for 10 min, and then, the infusion was reduced to 0.3–0.7 μg/kg/h and titrated to maintain an OAAS score of 3.[5]
As soon as the observer's assessment of alertness/sedation (OAAS) score of 3 was achieved, 10 ml of local anesthetic infiltration with 2% lignocaine and adrenaline solution was given subcutaneously followed by port insertion procedure by the surgeon. If, during the procedure, any patient had OAAS >3, rescue sedation of injection propofol 10 mg iv bolus was given, in both the groups. Drug infusion syringes were covered with brown paper to ensure blinding. Both patient and observer were blinded to the study. Injection ephedrine 6 mg/cc and injection atropine 0.6 mg/cc were kept ready for any adverse incident of hypotension (mean blood pressure [MBP] <60 mmHg) or bradycardia (heart rate [HR] <50). A crash cart was also kept ready so that any untoward complications could be handled. The infusions were stopped at the time of the first skin suture. After the completion of dressing of the port site, the patients were shifted to the post anesthesia care unit (PACU) for further observation and monitoring for 30 min and later shifted to a ward for further required management.
The observer's assessment of alertness/sedation (OAAS) score [Table 1], MBP, HR, oxygen saturation (SpO2), respiratory rate (RR), and BIS value were recorded at baseline and thereafter at 5 min interval till the port insertion is over. In PACU modified Aldrete score (MAS), HR and MBP were recorded at 10 min interval for 30 min. At the end, the satisfaction scores of anesthesiologist, surgeon, and patient were also recorded. Once the patient achieved MAS ≥9 [Table 2], they were shifted to the ward for their further management.[2],[6]
Statistical analysis
All continuous variables were expressed as mean ± standard deviation or median with an inter-quartile range as per the distribution of data. The categorical variables were expressed as number and their respective percentage. To compare two independent groups, Student's t-test or the Mann–Whitney U-test were used for continuous variables, whereas Chi-square test or Fisher's exact test were used for the categorical variables. All the reported P values will be two-sided and P < 0.05 shall be considered to indicate statistical significance. All data entries and statistical analyses were performed using Computer software SPSS version 23.0, India.
| Results | | |
All 50 enrolled patients satisfied the inclusion and exclusion criteria. Rescue sedation was required only in 6 cases [Table 3] all belonging to Group D, with the average dose of rescue sedation being 25 ± 13.78 mg. None of the patients had any episode of hypotension, bradycardia, or hypoxia. [Table 3] describes the demographic and clinical profile (age, sex, bmi, duration of surgery) of patients in both the groups and was comparable (P > 0.05). The time to achieve OAAS 3 [Table 3] was significantly longer (P < 0.05) in Group D as compared to Group P, with mean values being 8.04 ± 2.07 min in the former and 3.12 ± 1.17 min in the latter. [Figure 1] shows the comparable OAAS values at different times during the procedure in both the groups. Hemodynamic variables such as mean HR [Figure 2] and MBP [Figure 3] were also comparable in both the groups at different time points. [Figure 4] shows the BIS values at different time points during the procedure at OAAS value of 3. The average BIS value ranged between 65 and 70. [Table 4] and [Table 5] show the satisfaction and MAS, respectively, in both groups and are comparable. The average value of SpO2 was >97% in both groups (>0.05) and none of the patients had any episode of hypopnea (RR < 12). | Figure 1: Comparison of mean value of OAAS Score at different time points between the two groups. OAAS: Observer's assessment of alertness/sedation score
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 | Figure 2: Mean HR at different time points in both the groups. HR: Heart rate
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 | Figure 3: MBP in mmHg at different time points in both the groups. MBP: Mean blood pressure
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 | Figure 4: Mean BIS value at different time points in both the groups. BIS: Bispectral index
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| Discussion | | |
Monitored anesthesia care (MAC) is an anesthesia technique combining local anesthesia with parenteral drugs for sedation and analgesia. The use of MAC is increasing for a variety of diagnostic and therapeutic procedures in and outside the operating room due to the rapid postoperative recovery with the use of relatively small amounts of sedatives and analgesics as compared to general anesthesia. However, the application of sedatives and analgesics should be titrated to avoid central respiratory depression and airway obstruction, since the airway of the patient is not secured during MAC. Further, it is important to measure the level of sedation to prevent overt and under sedation. We have used OAAS in our study, where a patient is assessed by observing the response of stimuli under sedation. This scale has been proven as reliable and valid when compared with other standard tests of sedation.[7]
In our study, we found the average time to achieve OAAS score 3 in Group P was 3.12 ± 1.17 min and in Group D, 8.04 ± 2.07 min (P < 0.05), as shown in [Table 3]. The OAAS score of 3 achieving time was significantly less in Group P. This less time to achieve an OAAS score of 3 had a very important role for chemoport insertion. It helps in alleviating the anxiety of patients early as the patient remains awake under drape till the sedative has its effect. Less time to achieve an OAAS of 3 means the duration for which the patient remains awake decreases and so does anxiety. This also reduced the waiting time for the surgeon, as until the desired level of sedation is achieved, they have to wait and it is a waste of precious time. Thus, it also improved the satisfaction level of the patients and surgeon.[8],[9] This is consistent with the previous study done by Wang et al.,[10] where they used the Ramsay Sedation Scale (RSS) for conscious sedation in inguinal hernia repair.[6] Their target sedation score was RSS 3 and found the time to achieve RSS 3 was 25.5 ± 6.4 min and 12.3 ± 4.2 min in dexmedetomidine and propofol groups, respectively, with significantly less time to achieve target sedation in propofol group (P = 0.001). Similar outcome of early sedation with propofol as compared to dexmedetomidine was also found in meta-analysis conducted by Nishizawa et al., for gastrointestinal endoscopy.[8] Micķeviča et al.[11] also found the early onset of sedation with propofol as compared to dexmedetomidine in elective colonoscopy cases.[11] It may be due to the differences in pharmacodynamics of the drugs. Propofol acts through γ-aminobutyric acid-A (GABA-A) receptor, the principal inhibitory neurotransmitter in the brain.[12] It has sedative and hypnotic effects that are mediated by the GABA receptor. It is highly lipophilic and thus can rapidly cross the blood − brain barrier, resulting in an early onset of action. Dexmedetomidine, on the other hand, acts through the α2-adrenergic receptor at Locus coeruleus of the brain stem and has a disadvantage that the method of its administration is somewhat complicated, as the loading dose up to 1 μg/kg should be given over no <10 min.[13] The slow initial infusion avoids the undesirable hemodynamic changes that occur with faster infusion but takes longer time for sedation.
One of the secondary objectives was to maintain an OAAS score of 3 throughout the procedure, which we were successfully able to maintain in all the patients. As shown in [Figure 1] (P > 0.05), the average OAAS score during the surgical procedure was around 3. The maintenance of an OAAS score 3 throughout the procedure meant adequate sedation for the patient, optimal operating condition for the surgeon and minimal intervention from anesthetist.
[Table 4] shows comparable satisfaction scores in Group D and P. The maintenance of the OAAS score of 3, along with adequate analgesia and good operating condition throughout the procedure ensured a desirable satisfaction score among patients, surgeons and the anesthetist. The average value in Group D and P was 4.8 ± 0.41 and 4.84 ± 0.37, respectively, with P > 0.05. This was comparable in both the groups and consistent with Shen et al. and Wang et al. (P = 0.326)[10] where they used a 7-point Likert verbal rating scale for satisfaction.[14],[15]
Although we were able to maintain an OAAS score of 3 throughout the procedure, 6 patients (24%) in Group D were not able to achieve a score of 3 even though a 10-min bolus dose of dexmedetomidine was given, so we have to give rescue sedation of 10 mg propofol, as shown in [Table 3]. The average dose of rescue sedation in Group D was 25 ± 13.78 mg, but in Group P not even single patient required rescue sedation. Thus, it is beneficial relating to Group P, where we only have to titrate the infusion, there is no need to intermittently check the OAAS and no need to wait much to start the procedure.
Decrease in HR is a major effect of α-2 agonistic agents because it causes central and peripheral sympatholytic effects that are mediated by the activation of α-2 adrenoceptors and imidazoline-preferring receptors in the ventrolateral medulla and solitarius nucleus tract.[16] In our study, none of the patients had any episode of bradycardia (HR < 50/min). In fact, average HR was comparable in both the groups at different time points as shown in [Figure 2]. Similarly, the average MBP was also comparable in both the groups, as shown in [Figure 3]. Although the mean value of MBP most of the time in Group D was more than in Group P, statistically not significant (P > 0.05).[9] There were no episodes of hypotension (MBP <60 mmHg) in any group of the current study. It signifies that the hemodynamic effects of both the drugs in the study at our selected range of infusion dose are comparable and not significantly different. This is consistent with previous study done by Kaygusuz et al. where they did not find significant differences in the MBP values between the dexmedetomidine and propofol group (P > 0.05).[4]
In the current study, we did not find any event of respiratory depression (RR <9) in either group. This is consistent with Chun et al. during chemoport insertion where they did not find any episode of respiratory depression in their study group.[2] None of the patients had any episode of fall in SpO2 (P > 0.05) intraoperatively and postoperatively.
Chemoport insertion is a day care procedure and it is very important to shift the patient early from the PACU, so as to start chemotherapy early. In the current study, we were monitoring the patients in the PACU for 30 min, and assessing the MAS, so that we can compare and able to find which group is full-filling the discharge criteria earlier.[2],[6]
The normal shiftable MAS value from PACU should be ≥9.[2],[6] All the patients in both the groups had MAS >9 [Table 5] at all-time points in PACU, all of them had required MAS value and the P value was clinically insignificant. In view of academic interest, we observed the BIS value achieved during the procedure at an OAAS score of 3, so that we could assess the sedation level without repeatedly calling the patient as done in OAAS assessment and also it will help us in maintaining the required sedation through titrating the infusion of drugs in future without awakening the patient. The average BIS in this study during the surgical procedure was comparable in both the groups and it was at a range of 65 − 70 at different time points, as shown in graph 5.
Limitations
In the current study, the satisfaction score we used was a subjective assessment and may vary from person to person. Since we do not have any recommended BIS value for acceptable sedation for chemoport insertion in any of the previous work, we used OAAS score to know the sedation level of the patients, which had a limitation that we had to repeatedly call the patient, which hampered the sedation level.
| Conclusion | | |
In the current study, we found that propofol infusion was better in regard to the early onset and maintenance of OAAS score 3 with no requirement of rescue sedation during the procedure. The hemodynamic parameters and satisfaction score were comparable in both groups. Hence, we suggest the use of injection propofol infusion for MAC under sedation in patients requiring internal jugular vein chemo port insertion when compared to dexmedetomidine.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Chang DH, Hiss S, Herich L, Becker I, Mammadov K, Franke M, et al. Implantation of venous access devices under local anesthesia: Patient's satisfaction with oral lorazepam. Patient Prefer Adherence 2015;9:943-9.  |
| 2. | Chun EH, Han MJ, Baik HJ, Park HS, Chung RK, Han JI, et al. Dexmedetomidine-ketamine versus dexmedetomidine- midazolam-fentanyl for monitored anesthesia care during chemoport insertion: A prospective randomized study. BMC Anesthesiol 2016;16:49. |
| 3. | Koruk S, Mizrak A, Gul R, Kilic E, Yendi F, Oner U. Dexmedetomidine-ketamine and midazolam-ketamine combinations for sedation in pediatric patients undergoing extracorporeal shock wave lithotripsy: A randomized prospective study. J Anesth 2010;24:858-63. |
| 4. | Kaygusuz K, Gokce G, Gursoy S, Ayan S, Mimaroglu C, Gultekin Y. A comparison of sedation with dexmedetomidine or propofol during shockwave lithotripsy: A randomized controlled trial. Anesth Analg 2008;106:114-9. |
| 5. | Dere K, Sucullu I, Budak ET, Yeyen S, Filiz AI, Ozkan S, et al. A comparison of dexmedetomidine versus midazolam for sedation, pain and hemodynamic control, during colonoscopy under conscious sedation. Eur J Anaesthesiol 2010;27:648-52. |
| 6. | |
| 7. | Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, et al. Validity and reliability of the observer's assessment of Alertness/Sedation Scale: Study with intravenous midazolam. J Clin Psychopharmacol 1990;10:244-51. |
| 8. | Nishizawa T, Suzuki H, Hosoe N, Ogata H, Kanai T, Yahagi N. Dexmedetomidine versus propofol for gastrointestinal endoscopy: A meta-analysis. United European Gastroenterol J 2017;5:1037-45. |
| 9. | Wu Y, Zhang Y, Hu X, Qian C, Zhou Y, Xie J. A comparison of propofol versus dexmedetomidine for sedation, haemodynamic control and satisfaction, during esophagogastroduodenoscopy under conscious sedation. J Clin Pharm Ther 2015;40:419-25. |
| 10. | Wang HM, Shi XY, Qin XR, Zhou JL, Xia YF. Comparison of dexmedetomidine and propofol for conscious sedation in inguinal hernia repair: A prospective, randomized, controlled trial. J Int Med Res 2017;45:533-9. |
| 11. | |
| 12. | Rathmel JP, Roswo CE. Intravenous sedatives and hypnotics. In: Shafer S, Rathmell JP, Flood P, Stoelting R, editors. Handbook of Pharmacology and Physiology in Anesthetic Practice. 15 th ed. Philadelphia: Lippincott Williams & Wilkins; 2012. p. 119-43. |
| 13. | Afshani N. Clinical application of dexmedetomidine. S Afr J Anaesth Analg 2010;16:50-6. |
| 14. | Shen SL, Zheng JY, Zhang J, Wang WY, Jin T, Zhu J, et al. Comparison of dexmedetomidine and propofol for conscious sedation in awake craniotomy: A prospective, double-blind, randomized, and controlled clinical trial. Ann Pharmacother 2013;47:1391-9. |
| 15. | Alhashemi JA. Dexmedetomidine versus midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth 2006;96:722-6. |
| 16. | Hayashi Y, Guo TZ, Maze M. Desensitization to the behavioral effects of alpha 2-adrenergic agonists in rats. Anesthesiology 1995;82:954-62. |
[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]
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