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CTRI Number  CTRI/2024/01/061310 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 03/01/2024
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   checking the effect of fentanyl after giving two doses of injection dexmedetomidine before surgery in patients undergoing laparoscopic cholecystectomy  
Scientific Title of Study   comparison of total intraoperative rescue fentanyl consumption after two different doses of preoperative intravenous dexmedetomidine in laparoscopic cholecystectomy  
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 Deepak Thapa 
Designation  Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Anaesthesia and Intensive Care, D Block 5th floor, GMCH-32, Sector-32, Chandigarh.

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121524  
Fax    
Email  dpkthapa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Thapa 
Designation  Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Anaesthesia and Intensive Care, D Block 5th floor, GMCH-32, Sector-32, Chandigarh.


CHANDIGARH
160030
India 
Phone  9646121524  
Fax    
Email  dpkthapa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Thapa 
Designation  Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of Anaesthesia and Intensive Care, D Block 5th floor, GMCH-32, Sector-32, Chandigarh.


CHANDIGARH
160030
India 
Phone  9646121524  
Fax    
Email  dpkthapa@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, GMCH-32, Chandigarh. 
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive Care 
Address  Department of Anaesthesia and Intensive Care, D Block 5th floor, GMCH-32, Sector-32, Chandigarh. 
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 Deepak Thapa  Government Medical College and Hospital  Department of Anaesthesia and Intensive Care, D Block 5th floor, GMCH-32, Sector 32, Chandigarh.
Chandigarh
CHANDIGARH 		 9646121524

dpkthapa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ( GMCH, Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparing two different doses of dexmedetomidine   preoperative administration of two different doses intravenous dexmedetomidine for patients undergoing laparoscopic cholecystectomy and comparing total intraoperative rescue dose of fentanyl . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II of either sex
2. Age between 18 to 65 years
3. BMI ≥20 to≤35 kg m2
4. Scheduled for laparoscopic cholecystectomy surgery
 
 
ExclusionCriteria 
Details  1. Refusal by the patient
2. Patient with coagulopathy and bleeding disorder
3. Pregnant or lactating women
4. Contraindications or allergy to dexmedetomidine and fentanyl
5. Patient having hemodynamic instability.
6. Patients having pain in any area other than surgery site
 
 
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 
Total intraoperative rescue dose of fentanyl consumed.  0, 5, 15mins before induction, at the time of intubation and every 10 minutes after intubation till the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Haemodynamic response at 0, 5, 15mins before induction, at the time of intubation and every 10 minutes after intubation till the end of surgery.
2. Total induction dose of propofol consumed.
3. Post-operative VAS score at patient arrival at PACU, 5, 10, 15, 30 minutes 1, 3, 6, 12 and 24 hours.
4. Time to first rescue analgesia postoperatively.
5. Adverse effects if any.
 
 		 0 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   20/01/2024 
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="6"
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   All the patients will be evaluated preoperatively for fitness a day before the surgery for the proposed surgical procedure under General Anaesthesia.. All enrolled patients will be kept fasting after midnight and will be pre-medicated with T. Alprazolam 0.25 mg and T. Pantoprazole 40 mg orally , a night before surgery and two hours before the surgery. The patient will be shifted to the operation room and will be monitored using multi-channel monitors. Group 1 (n=25) patients will be administered intravenous dexmedetomidine 0.5 μg.kg-1 in 100 ml normal saline over 15 minutes. Group 2 (n=25) patients will be administered intravenous dexmedetomidine 0.25 μg.kg-1 in 100 ml normal saline over 15 minutes. Group NS (n=25) patients will be administered  100 ml normal saline over 15 minutes. All the patients will be administered intravenous fentanyl 2 μg.kg-1  followed by pre oxygenation with 100 % oxygen for 3 minutes.. After induction and intubation Anaesthesia will be maintained with N2O and O2 in a ratio of 60:40 with sevoflurane and intermittent boluses of intravenous vecuronium 0.01 mg.kg-1 .. Tachycardia and hypertension (20% increase in HR and MAP respectively from their baseline values) will be corrected by a rescue dose of fentanyl 0.5 μg.kg-1. Fentanyl dose will be repeated after 10 minutes in case of unresolved tachycardia and hypertension. . All patients will receive intravenous paracetamol 1g 6 hourly for 24 hours postoperatively. In postoperative period patients will be assessed for pain by using VAS pain score for 24 hrs. Patients with VAS score ≥ 4 will receive a rescue analgesia of intravenous tramadol 2mg.kg-1. 
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