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Comparison of Dexmedetomidine Vs. Pentazocine – Promethazine for Tympanoplasty Under MAC: a Randomized Double Blind Study

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Comparison of Dexmedetomidine Vs. Pentazocine – Promethazine for Tympanoplasty Under MAC: a Randomized Double Blind Study Original Research Article Indian Journal of Anesthesia and Analgesia1933 2018; 5(11): 1933­1940 DOI: http://dx.doi.org/10.21088/ijaa.2349.8471.51118.24 Comparison of Dexmedetomidine vs. Pentazocine – Promethazine for Tympanoplasty under MAC: A Randomized Double Blind Study Uttama Solanki1, Dhara Patel2, Shobhana Gupta3 1Assistant Professor 2Associate Professor 3Professor and Head, Department of Anesthesiology, GMERS Medical College and Civil Hospital, Gandhinagar, Gujarat 382012, India. Abstract Aim: To compare effectiveness of Dexmedetomidine with Pentazocine ­ Promethazine combination for intraoperative sedation under MAC for tympanoplasty under local anesthesia (LA). Methodology: Total 120 patients undergoing tympanoplasty under LA divided in to two groups randomly to receive either IV dexmedetomidine 1 mg/kg over 10mins followed by 0.2 mg/kg/h infusion (Group D) or Pentazocine 0.6mg/Kg and Inj. Promethazine 0.5 mg/kg IV diluted in 10ml normal saline over 10mins followed by 0.2 mg/kg/h infusion of normal saline (Group P). Sedation was titrated to RSS of 3. Vital parameters like HR, BP, SpO2, requirement of rescue analgesics, intraoperative bleeding scale, surgeon satisfaction score (Likert Scale) and Post Anesthesia Recovery Score (Modified Aldrete Score) were recorded and analyzed. Results: Intraoperative HR and MAP in Group D were lower than the baseline values and corresponding values in Group P (p<0.05). Intraoperative sedation in Group D was more than Group P (4 vs. 2 in a scale of 6). Intraoperative bleeding scale and surgeon satisfaction score was better in Group D than Group P (median interquartile range (IQR) 9 (8­10) vs. 8 (6.5­9.5) and 9 (8.5­9.5) vs. 8 (6.75­9.25), p = 0.0001 for both). Mean VAS for pain was more in group D than group P. Time for rescue analgesic was high with Group P while modified Aldrete score was high in Group D. Rate of occurrence of adverse drug reaction (ADR) was not statistically significant among two groups (p > 0.05). Conclusion: Dexmedetomidine is comparable to pentazocine ­ promethazine combination for sedation and analgesia in tympanoplasty with better surgical field and surgeon satisfaction, with better hemodynamic stability. Keywords: Dexmedetomidine; Pentazocine ­ Promethazine; Sedation; Tympanoplasty; Monitored Anesthesia Care. How to cite this article: Uttama Solanki, Dhara Patel, Shobhana Gupta. Comparison of Dexmedetomidine vs. Pentazocine – Promethazine for Tympanoplasty under MAC: A Randomized Double Blind Study. Indian J Anesth Analg. 2018;5(11):1933­40. Introduction done with under local anesthesia (LA) with Monitored anesthesia care (MAC). Less bleeding, cost effectiveness, early recovery and assessment of One of the commonest conditions encountered in ontable hearing during tympanoplasty are ENT outpatient department are Perforation of the advantages of using local anesthesia. Patient’s anxiety tympanic membrane and middle ear pathologies. caused by noise during surgery, dizziness and Middle ear surgeries can be carried out under general discomfort due to positioning of head and neck etc or local anesthesia [1­3]. Tympanoplasty, most are most common disadvantages of local anesthesia commonly performed ear surgery, involves during tympanoplasty [2­5]. These problems can reconstruction of perforated tympanic membrane with easily be overcome by administering appropriate or without reconstruction of ossicles [1]. It is usually sedatives as monitored anesthesia care. Most Corresponding Author: Dhara Patel, Associate Professor, Department of Anesthesia, GMERS Medical College and Civil Hospital, Gandhinagar, Gujarat 382012, India. E­mail: [email protected] Received on 20.08.2018, Accepted on 17.09.2018 ©RedIndian Flower Journal Publication of Anesthesia Pvt.Ltd and Analgesia / Volume 5 Number 11 / November 2018 1934 Uttama Solanki, Dhara Patel, Shobhana Gupta / Comparison of Dexmedetomidine vs. Pentazocine – Promethazine for Tympanoplasty under MAC: A Randomized Double Blind Study important elements of MAC are sedation, analgesia Methodology and control of anxiety [6]. During surgical procedure inhibition of movement by patient can be bring by Judicious use of MAC and patient still can respond This randomized, prospective, controlled, double to verbal commands as required for the surgical stage blind study was carried out in patients undergoing of operation. tympanoplasty surgery in otorhinolaryngology department of a tertiary care, teaching, rural hospital During MAC, wide variety of centrally active in western India. IV and inhaled drugs have been used including barbiturates, benzodiazepines, ketamine, propofol, opioid and nonopioid analgesics, a­agonists, and Ethical Consideration nitrous oxide [7,8]. Usually two or more drug The study protocol was approved by ethics the groups are combined and these drugs are institutional committee of the institute. Written administered pre­operatively in doses which can informed consent was obtained from all the achieve desired clinical response with minimal participants before enrolling them for the study. respiratory depression and hemodynamic fluctuations [9­12]. Benzodiazepines and opioids combination increases risk of hypoxia and apnoea Participant Selection [9,10]. Opioids can be used as the sole supplement Total 120 patients meeting inclusion­exclusion to local anesthetics but they fail to produce reliable criteria could be enrolled for the study after screening sedation in absence of respiratory depression. a2­ all the patients undergoing tympanoplasty. Inclusion agonists usually reduce central sympathetic criteria for the study were age of 18­50 years and of outflow and have shown to produce anxiolysis either gender, patients having grade ASA I & II, having and sedation at doses which produces relatively Mallampati grading of airway I & II and planned for very less adverse effects [11]. These drugs also help tympanoplasty under LA. Exclusion criteria were in attenuating the hemodynamic responses patients with any cardiac disease, chronic obstructive associated with anaesthesia by reducing lung disease, renal and hepatic insufficiency, CNS sympathetic outflow. Nausea­vomiting caused by disorders, pregnant and lactating female, and Pentazocine can becounteracting by a sedative sensitivity to LA drug and allergy to drugs. drug Promethazine. So, combination of pentazocine ­ promethazine is preferred for MAC [13]. Study Procedure By considering benefits of dexmedetomidine and The patients were counseled in detail about sedation, LA and operative procedure.All the patients pentazocine ­ promethazine, safety of use and were underwent Pre­anaesthetic checkup including desired therapeutic response achievement lead to detailed history, general and systemic examination increase in their use for the day care surgeries now and investigations. The visual analogue scale (VAS) a day. It is a common practice to use combinations (0­10, where 0 indicated no pain while 10 indicated of drugs for sedation and analgesia and focus is also maximum pain) was explained to the patients. shifting from the physician controlled techniques Preoperatively patients were advised to remain nil to patient controlled techniques due to level of by mouth for atleast 8 hours. Patient was shifted to stimulation and discomfort produced during operation theatre after confirming starvation and ambulatory surgical procedures varies widely consent. All baseline vital parameters; HR, SBP, DBP, among different patients. There is no standard MAP and SpO2 were recorded by multi­para monitor. dosage regimen or dosage formulation that can be Ringer lactate solution was started after Intravenous applied to all patients undergoing MAC. The need (IV) access was secured. All the patients were given of the current anesthetic practice is tailor made oxygenat 2 L/min via nasal cannula. As pre­ approach for each patient. Proper knowledge and medications, Inj. Ranitidine 1mg/kg, inj. skills are required for designing such regimens and Ondansetron 0.08mg/kg and inj. Glycopyrolate to use all the drugs effectively. 0.004mg/kg IV were given to all patients Therefore, this study was planned to compare All eligible patients were allocated in two groups effectiveness of intraoperative sedation as MAC randomly by chit method. The anesthesiologist between Dexmedetomidine and Pentazocine ­ conducting the case, patients and anesthesiologist Promethazine for tympanoplasty surgery under in the post anesthesia care unit (PACU) were all local anesthesia. blinded to group assignment.Blinded observer Indian Journal of Anesthesia and Analgesia / Volume 5 Number 11 / November 2018 Uttama Solanki, Dhara Patel, Shobhana Gupta / Comparison of Dexmedetomidine vs. Pentazocine – 1935 Promethazine for Tympanoplasty under MAC: A Randomized Double Blind Study recorded the data and the anesthesiologist who did Statistical Analysis not participate in patient management or data All the data were recorded as appropriate as collection had prepared the drugs actual frequency, percentage, mean, standard Group D: This group received Dexmedetomidine deviation. Data entry was done in Microsoft excel 1 mg/kg in 10ml normal saline (NS) over 10 minutes andepi info software was used for analyzing data. followed by it’s infusion at a rate of 0.2 mg/kg /hr The Chi Square Test was used for analyzing all the through infusion pump. qualitative data and students’ paired and unpaired Group P: This group received a standard dose of t test as appropriatefor quantitative data. p Pentazocine 0.6mg/kg and Inj.Promethazine
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