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CTRI Number  CTRI/2017/11/010456 [Registered on: 10/11/2017] Trial Registered Retrospectively
Last Modified On: 20/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of effectiveness of Dexmedetomidine in low dose to provide pain relief, when administered either Intravenously or inside abdomen during laparoscopic Cholecystectomy 
Scientific Title of Study   Comparison of post-operative Analgesic Efficacy of Low Dose Dexmedetomidine administered either Intravenous or Intraperitoneal with Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized, controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geetanjali T Chilkoti 
Designation  Associate Professor 
Affiliation  University College of Medical Sciences 
Address  Department of anaesthesiology and Critical Care, University College of Medical Sciences, GTB Hospital, Delhi

East
DELHI
110095
India 
Phone  9868399782  
Fax    
Email  geetanjalidr@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Kumar  
Designation  Postgraduate Student 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology and Critical Care, University College of Medical Sciences, GTB Hospital, Delhi

East
DELHI
110095
India 
Phone  8376901957  
Fax    
Email  kumarmanish.kumar31@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geetanjali T Chilkoti 
Designation  Associate Professor 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology and Critical Care, University College of Medical Sciences, GTB Hospital, Delhi

East
DELHI
110095
India 
Phone  9868399782  
Fax    
Email  geetanjalidr@yahoo.co.in  
 
Source of Monetary or Material Support  
University College of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi 
 
Primary Sponsor  
Name  University College of Medical Sciences and GTB Hospital 
Address  Dilshad Garden, Delhi-110095 
Type of Sponsor  Government medical college 
 
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 Geetanjali T Chilkoti  University College of Medical Sciences and GTB Hospital  Department of Anaesthesiology and Critical Care, Second floor, OT block
East
DELHI 		 9868399782

geetanjalidr@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituition Ethics Committee- Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing laparoscopic cholecystectomy for Gall stone disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group - II  Patients will receive 0.5µg/kg Dexmedetomidine infusion IV in 30 ml NS over 10 mins + 35 ml of 0.25% Bupivacaine intraperitoneal 
Intervention  Group - III  Patients will receive 30 ml NS intravenously+ 0.5µg/kg Dexmedetomidine diluted in 5 ml saline and added to 30 ml of 0.25% Bupivacaine intraperitoneal 
Comparator Agent  Group I  Patients will receive 30 ml of normal saline (NS) IV over 10 mins soon after removal of gall bladder + 35 ml of 0.25% Bupivacaine intraperitoneal 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. ASA I and II patients
2. Aged 18-50 years,
3. Undergoing laparoscopic cholecystectomy under GA 
 
ExclusionCriteria 
Details  1. BMI > 30 kg/m2

2. Allergy to any medication
3. Renal or hepatic insufficiency
4. Neurologic and psychiatric disease
4. Preoperative HR< 45/min
5. On antihypertensive medication with any α2 adrenergic agonists e.g. clonidine
6.surgical procedure converted to open cholecystectomy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to the first request of analgesia in the post‑operative period  24 hours post‑operative period 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total dose of diclofenac consumption in 24 h period (post‑operative)
2. Visual analogue scale [VAS]) pain score
3. Any adverse/side effects.
 		 24 h period post‑operative  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   11/01/2017 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Laparoscopic cholecystectomy is the most commonly used general surgical procedure for symptomatic cholelithiasis. The pain management in the immediate postoperative period is the mainstay of postoperative care in patients undergoing laparoscopic cholecystectomy. In last few years, the use of IV dexmedetomidine (alpha-2 agonist) in patients undergoing laparoscopic cholecystectomy has shown many beneficial effects like reduced anesthetic requirement, reduced inflammatory response, reduced postoperative pain, reduced shivering, better hemodynamic response to pneumoperitoneum, and recently have been found to benefit the cognitive function in elderly patients. All the aforementioned studies evaluating the postoperative analgesic effect of IV dexmedetomidine have used it in a dose of 1µg/kg bolus, followed by an infusion of 0.5µg/kg /hr. The dose of 1µg/kg is known to cause an initial rise in blood pressure which is followed by hypotension and reflex fall in HR. This ‘’Biphasic response’’ is seen more often in young, healthy patients. Recently, low dose infusion of dexmedetomidine at the rate of 0.4 mcg/kg/h without any bolus dose has been found to be a very useful anaesthesia adjuvant to control haemodynamic stress response to pneumoperitoneum and reduces the postoperative analgesic requirements without any significant adverse effects in patients undergoing laparoscopic cholecystectomy. Intraperitoneal instillation of local anaesthetic agents has become an important method to control post�’operative pain, nausea, vomiting and reduced hospital stay. Various authors have used intraperitoneal administration of dexmedetomidine 1 μg/kg combined with bupivacaine improves the quality and the duration of postoperative analgesia and provides an analgesic sparing effect compared to bupivacaine alone without significant adverse effects in patients undergoing laparoscopic colorectal cancer surgery. With this background, we undertake the present study to evaluate the postoperative analgesic efficacy of low dose dexmedetomidine (0.5µg/kg) either by intravenous or intraperitoneal route with 0.25% bupivacaine in patients undergoing laparoscopic cholecystectomy.The primary outcome being Time to first request of Analgesia and the secondary outcomes include total fdose of diclofenac consumption in 24 hr, VAS score and any adverse effects..

 

 
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