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CTRI Number  CTRI/2024/05/067316 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized comparative study to compare the effect of intraperitoneal dexmedetomidine and intravenous dexmedetomidine on the post operative recovery and inflammatory response in patients undergoing laparoscopic cholecystectomy  
Scientific Title of Study   Effect of intraperitoneal dexmedetomidine versus intravenous dexmedetomidine on recovery profile and inflammatory response following laparoscopic cholecystectomy : a randomized comparative 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  Dr Ruchi Kapoor 
Designation  Professor 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur hospital 
Address  Room no 731A, 7th floor OT block, Dept of anaesthesiology,University College of Medical Sciences and Guru Teg Bahadur hospital, North East Delhi, 110095, India

North East
DELHI
110095
India 
Phone  9560678023  
Fax    
Email  rudoc@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Kapoor 
Designation  Professor 
Affiliation  UCMS and GTB hospital 
Address  Room no 731A, 7th floor OT block, Dept of anaesthesiology, UCMS and GTB hospital, North East Delhi, 110095, India


DELHI
110095
India 
Phone  9560678023  
Fax    
Email  rudoc@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Garg 
Designation  Post Graduate resident 1st year 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur hospital 
Address  ICU 2nd floor Department of Anaesthesiology University College of Medical Sciences and Guru Teg Bahadur Hospital Dilshad Garden North East DELHI 110095 India

North East
DELHI
110095
India 
Phone  8191059256  
Fax    
Email  ashishgarg2306@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences and Guru Teg Bahadur Hospital,Dilshad Garden,North East,Delhi,110095,India 
 
Primary Sponsor  
Name  University College of Medical Sciences and Guru Teg Bahadur Hospital 
Address  Guru Teg Bahadur hospital, Dilshad garden,New 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 Ruchi Kapoor  University College of Medical Sciences and Guru Teg Bahadur Hospital  2nd floor, Department of Anaesthesiology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi, 110095
North East
DELHI 		 9560678023

rudoc@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intraperitoneal Dexmedetomidine(IP)  Each patient will receive intravenous 50 ml normal saline over 10 minutes when the surgeon initiates dissection of the gall bladder and intraperitoneal Dexmedetomidine(0.7µg/kg) mixed with 0.2% Ropivacaine in a total volume of 40 ml solution instilled after the removal of the gall bladder.  
Comparator Agent  Intravenous Dexmedetomidine(IV)  Each patient will receive an intravenous infusion of Dexmedetomidine 0.7µg/kg diluted in 50 ml normal saline over 10 minutes when the surgeon initiates the dissection of gall bladder and intraperitoneal Ropivacaine 0.2 % in a total volume of 40ml instilled after the removal of the gall bladder.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Consenting male or female patients aged 18-60 years scheduled for elective
Laparoscopic cholecystectomy under general anaesthesia.
2. Belonging to ASA grade I or II
 
 
ExclusionCriteria 
Details 
1. Patients with abnormalities like heart block, conduction defect in pre-operative ECG
2. Patients with known allergies to the study drugs
3. Obese patients (BMI ≥ 30)
4. Patients in whom subhepatic drain is inserted after gall bladder removal
 
 
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 
Comparison of time for extubation in the two groups.  Time taken from administration of reversal drug to removal of endotracheal tube 
 
Secondary Outcome  
Outcome  TimePoints 

To compare between the two groups various inflammatory markers such as:-
i) IL-6
ii) CRP
iii) S. Cortisol
iv) S. Albumin
v) Blood Glucose
 		 pre-operative and six hours post induction 
To compare between the two groups –
1.Time to discharge from PACU using Modified Aldrete score. 2. Hemodynamic parameters at the time of extubation
3 Post-operative pain using Numeric Rating Scale (NRS)
 		 post operative 
To compare between the two groups –
Amount of rescue analgesia required in 24 hours 		 24 hours post operative 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   25/05/2024 
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="1"
Months="2"
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 - NO
Brief Summary  
Patient will be taken to OT and vital monitoring systems attached, routine steps of general anaesthesia followed.
An 18G iv cannula will be inserted blood sample collected for a baseline evaluation of biochemical markers included in the study objectives.
During gall bladder resection, the IV group receives Dexmedetomidine (0.7µg/kg) infusion, while the IP group receives normal saline alone, for 10 minutes.
Post-resection, the IV group receives 40ml 0.2% Ropivacaine, while the IP group receives a 40ml mixture of Dexmedetomidine (0.7µg/kg) with 0.2% Ropivacaine.  
10 ml of this solution will be given on either side into the subdiaphragmatic space in a fan shaped manner by the surgeon. The remaining solution will be instilled in the gall bladder bed.
Modified Aldrete scoring with a score of ≥9 will be used as a criteria to discharge the patient from PACU. 
Postoperative pain will be assessed using the NRS immediate post operatively and then at 30 min, 1 h, 2h, 6h, 12 h and 24 h postoperatively. In patients with NRS >4, a bolus dose of Tramadol 50 mg intravenous (not to be repeated before 8 hours) will be administered as rescue analgesia along with Ondansetron 0.1 mg/kg to prevent emesis. 
Time to demand of first rescue analgesic and its total consumption in 24 hours will be noted.
At 6 hours post induction, blood sample will be sent for evaluation of biochemical markers along with the routine post operative investigations.
 
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