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ORIGINAL ARTICLE
Year : 2020  |  Volume : 21  |  Issue : 2  |  Page : 129-133
 

The study of intranasal dexmedetomidine during total intravenous anesthesia for endoscopic retrograde cholangiopancreatography


1 Department of Anaesthesia, Baptist Hospital, Bengaluru, Karnataka, India
2 Department of Anaesthesia, M. S. Ramaiah Medical College, Bengaluru, Karnataka, India

Date of Submission30-Dec-2019
Date of Acceptance04-Feb-2020
Date of Web Publication19-Sep-2020

Correspondence Address:
Dr. Leena Harshad Parate
Department of Anaesthesia, M. S. Ramaiah Medical College, MSRIT Post, Bengaluru - 560 054, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/TheIAForum.TheIAForum_98_19

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  Abstract 


Background: Anesthesia for endoscopic retrograde cholangiopancreatography poses many challenges. The level of sedation is highly unpredictable and can shift from conscious to deep sedation with the loss of protective reflexes. Propofol, which is a popular drug, has a narrow therapeutic index. We study the effect of intranasal dexmedetomidine on propofol and fentanyl consumption.
Materials and Methods: Ninety patients were randomly divided into two groups to receive either intranasal 1.5 μg/kg dexmedetomidine or saline. After 1 h, the procedure was commenced. Propofol and fentanyl were used to conduct anesthesia. The primary outcome was intraoperative propofol and fentanyl consumption. The secondary outcome was preprocedural hemodynamic parameter and sedation score.
Results: There was no statistically significant difference found in terms of demographic data (age, sex, height, weight, or BMI), duration of procedure, basal hemodynamic parameters, and sedation scale. There was a significant reduction in propofol (227.11 ± 61.27 mg vs. 146.89 ± 31.25 mg) and fentanyl (98.11 ± 13.95 μg vs. 82.44 ± 13.34 μg) consumption in the dexmedetomidine group. There was a significant reduction in pulse rate (95.13 ± 11.00 vs. 82.89 ± 9.45) and mean arterial pressure (98.27 ± 6.40 vs. 91.44 ± 8.02) at 60 min in the dexmedetomidine group. The preprocedural sedation score was statistically significantly reduced in the dexmedetomidine group (4.80 ± 0.40 vs. 3.67 ± 0.48).
Conclusion: Intranasal administration of 1.5 μg/kg dexmedetomidine can reduce perioperative anesthetic drug requirements. It provides better preprocedural sedation score and hemodynamic profile.


Keywords: Dexmedetomidine, endoscopic retrograde pancreatography, intranasal, total intravenous anesthesia


How to cite this article:
Prakash D, Parate LH, Nagaraj M C, Pujari VS, Reddy B, Dinesh N. The study of intranasal dexmedetomidine during total intravenous anesthesia for endoscopic retrograde cholangiopancreatography. Indian Anaesth Forum 2020;21:129-33

How to cite this URL:
Prakash D, Parate LH, Nagaraj M C, Pujari VS, Reddy B, Dinesh N. The study of intranasal dexmedetomidine during total intravenous anesthesia for endoscopic retrograde cholangiopancreatography. Indian Anaesth Forum [serial online] 2020 [cited 2020 Oct 24];21:129-33. Available from: http://www.theiaforum.org/text.asp?2020/21/2/129/295393





  Introduction Top


Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure that requires deep anesthesia and analgesia as studies have shown success rate increases with the deeper level of anesthesia.[1] The various challenges for anesthesiologist are ERCP is a painful and variable duration procedure done most commonly in the prone position. The procedure is done in an endoscopy suite (outside the operation theater complex) which could be least prepared area for any cardiorespiratory disasters. Lack of vaporizers necessitates the higher dose of intravenous agents. A change in the level of sedation from deep sedation to general anesthesia may occur inadvertently, with a relatively small alteration in the dose of sedative drugs used.

There is paucity in the literature about the use of intranasal route of dexmedetomidine in tubeless total intravenous anesthesia (TIVA) technique. While the literature has proved the benefits of dexmedetomidine using the subjective assessment such as sedation scales, there are very few studies done to prove its effectiveness by assessing the actual anesthetic drug consumption.[2],[3],[4]

This study, therefore, intends to exploit the sedative, analgesic, sympatholytic properties of dexmedetomidine as a premedicant intranasally to minimize propofol and fentanyl consumption in patients under TIVA.


  Materials and Methods Top


This randomized, double-blind, placebo-controlled study was approved by the hospital ethics and research committee and registered in the clinical trial registry (CTRI/2018/04/013308). Ninety patients undergoing ERCP under TIVA were recruited in the study. Patients aged between 20 and 70 years of the American Society of Anesthesiologists (ASA) Status I to III class were included in the study, and informed consent was obtained. Pregnant patients, severely obese (body mass index [BMI] >35 kg/m2), history of OSA, nasal pathology, and chronic sedative use were excluded from the study.

All the patients recruited in the study were shifted to the preoperative room 1 h before the procedure. An 18G/20G cannula was secured. Heart rate (HR), noninvasive blood pressure, and pulse oximetry (SPO2) were monitored at the baseline and every 15 min thereafter. Patients were randomly allocated (1:1) to receive either undiluted dexmedetomidine 0.015 ml/kg (1.5 μg/kg) (Group D) or 0.9% saline (0.015 ml/kg) (Group S) intranasally 1 h before the procedure. A computer-generated random sequence was used for drug allocation. The drug was administered intranasally after dividing it into two equal volumes for each naris, with the patient in semirecumbent position and the head end elevated to around 20°–30° angle. The anaesthesiologist who was not involved in the study prepared and administered the drug. The Observer's Assessment of Alertness/Sedation (OAA/S) Scale was used to measure the level of alertness in the participants. OAA/S scale was assessed every 15 min after the administration of the test drug, and vitals as mentioned above were recorded every 15 min.

After 1 h, the patient was shifted to the procedure room and anesthesiologist unaware of group allocation conducted the anesthesia. ASA standard monitors were applied. All patients received 10% lignocaine spray, 3 sprays (10 mg/puff) orally. Oxygen was administered through nasal prongs at 4 L/min flow to all patients. Propofol 1.5 mg/kg and fentanyl 1 μg/kg were administered slowly as loading dose. Once the sedation score according to the OAA/S scale was <3, the procedure was commenced. Manual doses of propofol and fentanyl were given to maintain the depth of anesthesia as judged by the clinical signs. The usual indications for incremental doses of propofol were limb movements, facial grimace, and respiratory movements. Top up manual dose of propofol 0.25 mg/kg and fentanyl 10 μg was given. The start time was recorded when the scope was inserted into the oral cavity. HR below 50 was treated with intravenous (IV) atropine 0.6 mg. Hypotension was defined as the reduction in mean arterial pressure (MAP) by 30% and treated by IV mephentermine 6 mg. Once the procedure was complete, total dose of propofol and fentanyl and the duration of the procedure were calculated. Post procedure in the postanesthetic care unit, the patient was monitored for a further period of 30 min.

Outcome

The primary objective was total propofol and fentanyl consumption. The secondary objectives were to evaluate the hemodynamic changes and the sedation score attained preprocedure at 60 min.

Based on the study conducted by Cheung et al.,[2] statistical analysis was found that for a sample size of 50, with 25 in each group, the propofol consumption in the dexmedetomidine group after the procedure was 28 ± 23.9 mg as compared to 42.4 ± 23.5 mg in the placebo group. In this proposed study, the sample size was calculated considering an effect size of 0.5 and a power of 80% and an alpha error of 5%. The sample size worked out to be 45 in each group. Descriptive and inferential statistical analysis was carried out in the present study. The results on continuous measurements were presented on mean ± standard deviation (min–max), and the results on the categorical measurements were presented in numbers (%). Significance is assessed at 5% level of significance. Statistical software IBM©SPSS© (Statistical Package for the Social Sciences) version 18 (IBM © Corp., Armonk, NY, USA). was used for the analysis of the data. Student's t-test (two-tailed and independent) was used to find the significance of the study parameters on the continuous scale between the two groups (intergroup analysis) on metric parameters. The Chi-square/fisher's exact test was used to find the significance of study parameters on the categorical scale between two or more groups, nonparametric setting for qualitative data analysis. Fisher's exact test is used when the cell samples are very small.


  Results Top


Ninety patients who met the inclusion criterion were enrolled in the study and were allocated into either Group S or Group D (45 in each group). All patients underwent ERCP successfully without any episode of bradycardia, hypotension, and desaturation. Data of all 90 patients were analyzed. The demographic characteristics and various indications of ERCP are presented in [Table 1]. The two groups were comparable for age, weight, height, BMI, and duration of procedure.
Table 1: Demographic parameters

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The comparison of preprocedure pulse rate and mean arterial blood pressure (MAP) at various intervals is given in [Figure 1] and [Figure 2].
Figure 1: Comparison of pulse rate (bpm) between the two groups

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Figure 2: Comparison of mean arterial pressure (mm Hg) between the two groups

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Basal hemodynamic parameters and sedation scale were comparable in both groups. Comparison at 30 min onward showed a significant reduction in the pulse rate (95.13 ± 11.00 vs. 82.89 ± 9.45) and MAP (98.27 ± 6.40 vs. 91.44 ± 8.02) with maximum reduction seen at 60 min. The sedation score is given in [Figure 3]. It reveled statistical significant fall in sedation score at 30 min onward and maximum reduction achieved at 60 min (4.80 ± 0.40 vs. 3.67 ± 0.48). [Table 2] shows the comparison of total propofol and total fentanyl consumption in two groups. There was a significant reduction in the total dose of propofol (227.11 ± 61.27 mg vs. 146.89 ± 31.25 mg) and fentanyl (98.11 ± 13.95 μg vs. 82.44 ± 13.34 μg) in the dexmedetomidine group. The average reduction in propofol was 80.22 mg, whereas in fentanyl, it was 15.67 μg.
Figure 3: Comparison of sedation group between the two groups

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Table 2: Comparison of total propofol and fentanyl dose

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  Discussion Top


In our study, we found out that intranasal dexmedetomidine reduces the requirement of primary anesthetic agents such as propofol and fentanyl. In addition, it also provides excellent preprocedural sedation. Our findings are consistent with Cheung et al. who noted a significant reduction in the propofol and remifentanil consumption by using intranasal dexmedetomidine (1.5 μg/kg) in patients undergoing upper gastrointestinal endoscopy.[2] The mean reduction of propofol was 13.8 mg, and with remifentanil, it was 34.5 μg. We noticed few differences in their study and our study. First of all, they included only upper gastrointestinal endoscopy, which is less invasive and less complex compared to ERCP. ERCP poses special challenges as it is longer duration procedure, done in the prone position, requires complete immobilization of patient, and abolished gag reflex. Sphinctorotomy can elicit noxious stimuli. Other difference we noticed that their mean duration of procedure is just about 5 min while ours was 30 min.

Xiang et al. studied two doses (1 μ/kg and 2 μ/kg) of intranasal dexmedetomidine, with IV 1 μ/kg dexmedetomidine in patients undergoing hysterectomy.[4] They found out a significant reduction in propofol and remifentanil consumption by using both intranasal and IV dexmedetomidine. The maximum benefit was shown by IV dexmedetomidine with the highest episode of bradycardia requiring atropine (22.5%). While they used endotracheal anesthesia for conducting the case, ours was a tubeless total IV anesthesia technique. This technique requires meticulous attention of the airway as a sudden change in depth of anesthesia can be disastrous. Hence, we consider that the use of dexmedetomidine in the attenuating dose of propofol and fentanyl is ideal in this situation.

Many studies have already proven the benefit of IV dexmedetomidine in endoscopy.[5],[6] However, intranasal route is still not completely explored. Han et al., in their study, compared intranasal with IV route of dexmedetomidine in patients undergoing gastroscopy.[7] They found that intranasal route provides more stable cardiorespiratory parameters with less adverse reactions such as respiratory depression. IV route is known for delayed recovery.[8] In our study, none of the patient had delayed recovery.

Similar to previous studies, we also found a significant reduction in pulse rate and MAP with the onset of sedation at 30 min onward.[9] We did not study intraoperative hemodynamics as many patients received IV hyoscine butyl bromide for sphincter relaxation which is known to increase HR and blood pressure.

Propofol has a short half-life and faster recovery profile that has often been its advantage over other sedatives. Even though propofol provides excellent sedation and patient comfort, it has a narrow therapeutic window and the level of sedation can easily slip from the lighter plane of sedation to apnea. Upper gastrointestinal endoscopy may impair ready access to airway as it is a shared airway and is not protected with intubation. The loss of airway reflexes and apnea is what one must be cautious about during propofol-based sedation.

An analysis performed by the ASA closed claims database revealed that respiratory depression due to overdose of sedatives or opioids was accountable for 21% of monitored anesthesia care claims.[1] Hence, with the growing popularity of procedures done outside the operation theater, the appropriate sedation technique is must for every anesthesiologist.

Dexmedetomidine has been viewed as an ideal drug for procedural sedation.[10],[11] It has a unique way of providing sedation and analgesia. It resembles physiological sleep without causing any respiratory depression. With the increasing demand of propofol-based TIVA technique, we wished to study this strategy to reduce the propofol and fentanyl consumption. The ease of administration compared to IV route and lack of serious cardiorespiratory complications makes intranasal route, a safe alternative for dexmedetomidine administration. We feel this strategy may be useful in setup lacking target control infusion pumps for conducting TIVA.

The limitation of our study is that we exclude high-risk ASA IV, obese patients. Ideally, these are patients in whom propofol/fentanyl dose reduction strategy is most beneficial. More studies should be done to compare the intranasal and IV route for maximum benefits.


  Conclusion Top


We conclude that intranasal (1.5 μg/kg) dexmedetomidine as a premedicant is a promising drug with excellent hemodynamic profile and sedation scores. The anesthetic sparing effect of dexmedetomidine seen in our study significantly decreased the consumption of primary drugs such as propofol and fentanyl.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: A closed claims analysis. Anesthesiology 2006;104:228-34.  Back to cited text no. 1
    
2.
Cheung CW, Qiu Q, Liu T, Chu KM, Irwin MG. Intranasal dexmedetomidine in combination with patient controlled sedation during upper gastrointestinal endoscopy: A randomized controlled trial. Acta Anaesthesiol Scand 2015;59:215-23.  Back to cited text no. 2
    
3.
Uusalo P, Lehtinen M, Löyttyniemi E, Manner T, Scheinin M, Saari TI. Premedication with intranasal dexmedetomidine decreases barbiturate requirement in pediatric patients sedated for magnetic resonance imaging: A retrospective study. BMC Anesthesiol 2019;19:22.  Back to cited text no. 3
    
4.
Wu X, Hang LH, Wang H, Shao DH, Xu YG, Cui W, et al. Intranasally administered adjunctive dexmedetomidine reduces perioperative anesthetic requirements in general anesthesia. Yonsei Med J 2016;57:998-1005.  Back to cited text no. 4
    
5.
Sethi P, Mohammed S, Bhatia PK, Gupta N. Dexmedetomidine versus midazolam for conscious sedation in endoscopic reteograde chlolangio pancreatography: An open labeled randomized controlled trial. Indian J. Anaesth 2014;58:18-24.  Back to cited text no. 5
    
6.
Inatomi O, Imai T, Fujimoto T, Takahashi K, Yokota Y, Yamashita N, et al. Dexmedetomidine is safe and reduces the additional dose of midazolam for sedation during endoscopic retrograde cholangiopancreatography in very elderly patients. BMC Gastroenterol 2018;18:166.  Back to cited text no. 6
    
7.
Han G, Yu WW, Zhao P. A randomized study of intranasal vs. intravenous infusion of dexmedetomidine in gastroscopy. Int J Clin Pharmacol Ther 2014;52:756-61.  Back to cited text no. 7
    
8.
Muller S, Borowics SM, Fortis EA, Stefani LC, Soares G, Maguilnik I, et al. Clinical efficacy of dexmedetomidine alone is less than propofol for conscious sedation during ERCP. Gastrointest Endosc 2008;67:651-9.  Back to cited text no. 8
    
9.
Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg 2007;105:374-80.  Back to cited text no. 9
    
10.
Dinesh CN, Sai Tej NA, Yatish B, Vinayak PS, Mohan Kumar RM, Mohan CV. Effects of intravenous dexmedetomidine on hyperbaric bupivacaine spinal anesthesia: A randomized study. Saudi J Anaesth 2014;8:202-08.  Back to cited text no. 10
    
11.
Halaszynski TM. Dexmedetomidine: A look at a promising new avenue of use. Saudi J Anaesth 2012;6:104-6.  Back to cited text no. 11
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    Figures

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    Tables

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