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CTRI Number  CTRI/2024/10/074979 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Opioid sparing anesthesia in laparoscopic gall bladder surgery using Dexmedetomidine  
Scientific Title of Study   Comparison of analgesic efficacy of dexmedetomidine for opioid-sparing anesthesia with conventional opioid-based anesthesia for elective laparoscopic cholecystectomy: a prospective randomized controlled study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adarsh K P 
Designation  Primary DNB Resident 
Affiliation  Aster CMI Hospital 
Address  Department of Anesthesia 2nd floor Aster CMI Hospital Sahakara Nagar Bangalore

Bangalore
KARNATAKA
560092
India 
Phone  09496471379  
Fax    
Email  kpadarsh001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun V 
Designation  Head of Department 
Affiliation  Aster CMI Hospital 
Address  Department of Anesthesia 2nd floor Aster CMI Hospital Sahakara Nagar Bangalore

Bangalore
KARNATAKA
560092
India 
Phone  9496471379  
Fax    
Email  drarun.v@asterhospital.com  
 
Details of Contact Person
Public Query
 
Name  Dr Renita M Pinto 
Designation  Consultant 
Affiliation  Aster CMI Hospital 
Address  Department of Anesthesia 2nd floor Aster CMI Hospital Sahakara Nagar Bangalore

Bangalore
KARNATAKA
560092
India 
Phone  9496471379  
Fax    
Email  rensmarina@gmail.com  
 
Source of Monetary or Material Support  
Aster CMI Hospital, Sahakar Nagar, Bangalore, India 560092 
 
Primary Sponsor  
Name  Adarsh K P 
Address  Department of Anesthesia 2nd floor Aster CMI Hospital Sahakara Nagar Bangalore 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Adarsh K P  Aster CMI Hospital  Department of Anesthesiology Second floor Aster CMI Hospital Sahakara Nagar Bangalore
Bangalore
KARNATAKA 
9496471379

kpadarsh001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Instituitional Ethics Committee of Aster CMI Hospital, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional opioid based Anesthesia   Fentanyl 2mcg/kg at induction of general anesthesia Duration of intervention will be total intraoperative period  
Comparator Agent  Opioid sparing Anesthesia   Dexmedetomidine loading dose 0.3mcg/kg over 10 minutes at induction followed by 0.5mcg/kg/hr infusion continued till skin closure of surgery. Duration of intervention will be total intraoperative period  
Intervention  Opioid sparing Anesthesia with Dexmedtomidine  One group of patients are given Dexmedetomidine infusion with loading dose 0.3mcg/kg for 10min at induction of anaesthesia, followed by 0.5mcg/kg/hr continued till skin closure. Other group will be given Fentanyl 2mcg/kg at induction. Both groups will be premedicated with Midazolam, glycopyrolate, and general anaesthesia induced with titrated dose of Propofol and atracurium. Preincisional ultrasound guided right External oblique intercostal plane block and bilateral ultrasound guided rectus sheath block is also given. Inj Fentanyl 25mcg boluses will be given as rescue analgesic intraoperatively. Inj Paracetamol and Diclofenac is also used intraoperatively.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing elective laparoscopic cholecystectomy surgery
Patients under ASA 1 and ASA2 class
Baseline Heart rate more than 50beats per minute 
 
ExclusionCriteria 
Details  Patients of ASA 3 and above
Patient refusal
Patients on betablocker drugs
Patient with history of Cardiac arrhythmia
Patients with deraged renal function
Any history of allergy to any of study drugs
Patients with history of bronchial asthma
Patients at risk of aspiration
Pregnant and lactating mothers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Total (intraoperative and postoperative) rescue Fentanyl usage for analgesia when using Dexmedetomidine infusion compared to conventional opioid based anesthesia.   Total usage at 0hour post procedure
total usage till 24hour post procedure 
 
Secondary Outcome  
Outcome  TimePoints 
incidence of postoperative nausea & vomiting  post operative period till 24 hours 
time to extubation and eye opening to call  intraoperative  
any complication associated with dexmedetomidine or opioid  intraoperative & post operative period till 24 hours 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   12/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kpadarsh001@gmail.com].

  6. For how long will this data be available start date provided 01-10-2026 and end date provided 01-10-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Laparoscopic cholecystectomy is the minimally invasive gold standard procedure for the removal of gall bladder in conditions like cholelithiasis. Unfortunately, the incidence of postoperative nausea and vomiting is as high as 55.8% which delays recovery. Perioperative opioid use is considered to be one of the reasons for it. Opioid usage is also associated with itching, respiratory depression, paralytic ileus, urinary retention, constipation, dependency, and drowsiness. Opioid-sparing anaesthesia by minimizing the perioperative opioid usage may reduce the incidence of these adverse effects and enhance recovery. In this study, Dexmedetomidine is used for opioid-sparing anaesthesia. Dexmedetomidine is a highly selective pre-synaptic alpha-2  receptor agonist having sedative, anxiolytic, hypnotic, analgesic and sympatholytic properties. 

Various studies have shown the analgesic efficacy of dexmedetomidine and its hemodynamic stability in varying doses and in conjunction with other opioid sparing techniques. Studies have established the effect of dexmedetomidine in reducing post-operative nausea and vomiting compared to opoid based anaesthesia. This study compares opioid sparing effect of dexmedetomidine in conjunction with ultrasound-guided right external oblique intercostal nerve block and bilateral rectus sheath block for elective laparoscopic cholecystectomy against conventional opioid based technique.

Objective of the study is to measure total rescue opioid requirement in intraoperatiev and post operative period in using dexmetomidine infusion compared to conventional opioid based anaesthesia. Incidence of any post operative nausea vomiting, and any complication is also compared. Time to extubation and post operative pain scores are also compared

This is a prospective open label randomised control study conducted in Aster CMI Hospital, Bangalore, in 78 patients between 18 to 65years undergoing elective Laparoscopic Cholecystectomy surgery belonging to ASA 1 and ASA2. Any patients having contraindication to study drugs is excluded from the study.

One group  of patients are given Dexmedetomidine infusion with loading dose 0.3mcg/kg for 10min at induction of anaesthesia, followed by 0.5mcg/kg/hr. Other group will be given Fentanyl 2mcg/kg at induction. Both groups will be premedicated with Midazolam, glycopyrolate, and general anaesthesia induced with titrated dose of Propofol and atracurium. Preincisional ultrasound guided right External oblique intercostal plane block and bilateral ultrasound guided rectus sheath block is also given. Inj Fentanyl 25mcg boluses will be given as rescue analgesic intraoperatively. Inj Paracetamol and Diclofenac is also used intraoperatively. 

Perioperative vitals, total Fentanyl usage, post operative pain scores and any incidence of complication will be measured, analysed and compared 

 
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