FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090006 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Two Medicines (Fentanyl and Dexmedetomidine) to Reduce Stress During Keyhole Gallbladder Surgery 
Scientific Title of Study   Fentanyl versus Dexmedetomidine infusion for attenuation of the stress response to pneumoperitoneum during laparoscopic cholecystectomy: A randomized clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NO.:A/206/REB-COMM(SP)/RIMS/2015/1121/05/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dojingla Yimchunger 
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences, Imphal  
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal West MANIPUR 795004 India

Imphal West
MANIPUR
795004
India 
Phone  9901912155  
Fax    
Email  dojinglayimchunger@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr L Pradipkumar Singh 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal West MANIPUR

Imphal West
MANIPUR
795004
India 
Phone  7005238251  
Fax    
Email  drlaithangba@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr L Pradipkumar Singh 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal West MANIPUR

Imphal West
MANIPUR
795004
India 
Phone  7005238251  
Fax    
Email  drlaithangba@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur  
 
Primary Sponsor  
Name  Dojingla Yimchunger 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur 
Type of Sponsor  Other [Post Graduate Trainee] 
 
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 
Dojingla Yimchunger  Regional Institute of Medical Sciences, Imphal, Manipur   Elective surgery operation theatre complex (OT 1-8) Department of Anaesthesiology, Regional Institute of Medical Sciences
Imphal West
MANIPUR 		 9901912155

dojinglayimchunger@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD RIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: K81||Cholecystitis, (3) ICD-10 Condition: K82||Other diseases of gallbladder, (4) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine Infusion  Dexmedetomidine 20microgram diluted in 20ml normal saline will be infused at 10ml/hr to ensure a dose of 0.2micro gram per kg per hr. 
Intervention  Fentanyl Infusion  Fentanyl 100microgram diluted in 20 ml normal saline will be given at 10ml/hr to ensure a dose of 1microgram per kg per hr.  
Comparator Agent  Normal saline infusion  This control group will receive 20ml of normal saline only at 10ml per hr. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of either sex.
2. Age groups: 18-60 years.
3. ASA (American Society of Anesthesiology)15 Grade I and II.
4. Undergoing Laparoscopic Cholecystectomy.
 
 
ExclusionCriteria 
Details  Patients with uncontrolled hypertension despite of treatment.
Patient with Diabetes Mellitus (with autonomic neuropathy) despite of treatment.
Anticipated Difficult airway.
Conversion to open cholecystectomy.
Hypersensitive to study drugs.
Refusal to give consent.
Severely deranged renal and hepatic function.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the attenuation of hemodynamic stress response to pneumoperitoneum among study groups.  Hemodynamic parameters—namely heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP)—will be recorded at multiple defined time points. These include the baseline values recorded before induction of anesthesia, just before the creation of pneumoperitoneum (when the study drug infusion is started), and at 1, 3, and 5 minutes after pneumoperitoneum. Subsequently, these parameters will be monitored at every 10-minute interval throughout the duration of pneumoperitoneum and finally at the time of deflation of the pneumoperitoneum, which also coincides with the stopping of the study drug infusion.groups. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare
1. The sedative effects and duration of analgesia.
2. The time of first rescue analgesia request.
3. Side effects such as hypotension and bradycardia.
 		 Sedative effects will be assessed using the Ramsay Sedation Score at 15 and 30 minutes after extubation in the post-anesthesia care unit (PACU). The duration of analgesia will be measured from the point of stopping the study drug infusion to the time of the first request for rescue analgesia, which is determined when the patient reports a Visual Analogue Scale (VAS) pain score of 4 or more. The exact time of this first request will be documented. In addition, side effects such as hypotension, bradycardia, and postoperative nausea and vomiting (PONV) will be monitored throughout the intraoperative period and during the first two hours of observation in the PACU. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   15/07/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

This study “Fentanyl versus Dexmedetomidine for Attenuation of the Stress Response to Pneumoperitoneum during Laparoscopic Cholecystectomy: Randomized Clinical Trial.’’ will be conducted in the department of anesthesiology, RIMS, Imphal over a period of two years starting from January 2024. After obtaining ethical clearance and written informed consent, 60 patients (18-60 years, ASA I and II) will be randomized into one of the three group (n=20).

Group A patients will receive Dexmedetomidine 0.2 g/kg/hr given at 10 ml/hr after reconstitution with normal saline. Group B patients will receive Fentanyl 1 /kg/hr given at 10ml/hr after reconstitution with normal saline. Group C (control group) will receive only normal saline 10ml/hr. Infusion will be started just before pneumoperitoneum and continue till deflation of the pneumoperitoneum. Hemodynamic parameter (HR, SBP, DBP, MAP) will be recorded at every 1, 3 and 5 minutes after pneumoperitoneum and then every 10 minutes throughout the pneumoperitoneum. Ramsay sedation score will be monitored post operatively at 15 minutes and 30 minutes at PACU. Time for the first rescue analgesia will be given with Inj Diclofenac 75mg IM (or IV if aqueous) when VAS 4. Complications like postoperative nausea and/or vomiting (PONV) will be recorded.

Data will be recorded in proforma and tabulated in the EXCEL software and analysed using SPSS software. A p-value of less than 0.05 will be considered statistically significant.

 
Close