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CTRI Number  CTRI/2023/06/053717 [Registered on: 09/06/2023] Trial Registered Prospectively
Last Modified On: 07/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   DO WE REALLY NEED OPIOIDS? - A STUDY DONE IN CHOLECYSTECTOMY PATIENTS. 
Scientific Title of Study   COMPARISON OF OPIOID FREE ANAESTHESIA AND CONVENTIONAL GENERAL ANAESTHESIA IN PATIENTS UNDERGOING LAPROSCOPIC CHOLECYSTECTOMY – A PROSPECTIVE RANDOMISED 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 SHWETA DHIMAN 
Designation  ASSISTANT PROFESSOR 
Affiliation  NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA. NORTH DMC MEDICAL COLLEGE. MALKA GANJ. DELHI- 110007
MALKA GANJ,DELHI-110007
North
DELHI
110029
India 
Phone  9650474249  
Fax    
Email  13shweta1990@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHWETA DHIMAN 
Designation  ASSISTANT PROFESSOR 
Affiliation  NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA, NORTH DMC MEDICAL COLLEGE. DELHI-110007
MALKA GANJ,DELHI-110007
North
DELHI
110029
India 
Phone  9650474249  
Fax    
Email  13shweta1990@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SHWETA DHIMAN 
Designation  ASSISTANT PROFESSOR 
Affiliation  NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIA, NORTH DMC MEDICAL COLLEGE. MALKA GANJ. NEW DELHI-110007
MALKA GANJ,DELHI-110007
North
DELHI
110029
India 
Phone  9650474249  
Fax    
Email  13shweta1990@gmail.com  
 
Source of Monetary or Material Support  
NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL 
 
Primary Sponsor  
Name  NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL 
Address  MALKA GANJ, DELHI- 110007 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL  MALKA GANJ, DELHI- 110007 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SHWETA DHIMAN  DEPARTMENT OF ANAESTHESIA  DEPARTMENT OF ANAESTHESIA, NORTH DMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL. MALKA GANJ, DELHI-110007
North
DELHI 		 9650474249

13shweta1990@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONVENTIONAL GENERAL ANAESTHESIA  premedication with midazolam 1 mg IV and dexamethasone 0.1 mg/kg IV. The anesthesia will be induced using fentanyl 3ug/kg IV, propofol 2.5 mg/kg IV, and vecuronium 0.1 mg/kg IV. Anesthesia will be maintained using isoflurane between 0.5–2% and a continuous infusion of normal saline 10–15 ml/h as placebo.  
Intervention  OPIOID FREE ANAESTHESIA  premedication with lidocaine 1.5 mg/ kg IV, magnesium sulfate 40 mg/kg (in 100 ml of saline without exceeding 2.5 g), ketamine 25 mg IV and dexamethasone 0.1 mg/kg IV. Induction of general anesthesia will be carried out with propofol 1.5 mg/kg IV and vecuronium 0.1 mg/kg IV. Anesthesia will be maintained using isoflurane between 0.5–2%, and an infusion containing a mixture of magnesium sulfate 40 mg/kg (without exceeding a total dose of 2.5 g/24 h taking note of the induction dose), lidocaine 1.5 mg/kg, ketamine 0.25 mg/kg in 50 ml saline @ 10-15 ml/hr. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA grade I and II
2. BMI -18-25
3. Undergoing laparoscopic cholecystectomy
4. Written informed consent
 
 
ExclusionCriteria 
Details  • history of allergy to any drug used for OFA or CGA;
• history of alcohol, opioid or drug abuse;
• chronic pain
• psychiatric illness;
• patients undergoing surgery with planned regional anesthesia,
• patients with iatrogenic surgical complications such as bowel, ureter or bladder injuries.
• Duration of surgery exceeding 90 minutes.
• pregnancy
 
 
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 
the intraoperative need to administer opioids for adequate intraoperative analgesia.  1) INTRAOPERATIVE
2) POSTOPERATIVE TILL 48 HRS AFTER THE SURGERY 
 
Secondary Outcome  
Outcome  TimePoints 
1. Occurrence of intra-operative complications e.g. hypotension, hypertension, tachycardia and bradycardia.
2. Mean alveolar concentration (MAC in %) of isoflurane used in both groups.
3. Pain intensity (assessed using the Numerical Rating scale)
4. Need for opioids for pain relief within the first 48 h of surgery;
5. Patient satisfaction (assessed on the Quality of Recovery-40 [QoR-40] questionnaire) at 24 h and 48 h postoperation
 		 intra-operative & post operative period (24 & 48 hrs) 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   03/07/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 [13shweta1990@gmail.com].

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 01-05-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Opioid free anaesthesia is a technique of providing anaesthesia by combining intravenous administration of a combination of non opioid agents to produce adequate intraoperative analgesia, hypnosis, sympatholysis and pain free awakening. Although opioid analgesics have been the mainstay of conventional general anaesthesia due to their analgesic effect, they are also associated with respiratory depression, gastrointestinal symptoms, urine retention, psychological deficiencies, inflammation modulation & immune depression. To the best of our knowledge, there is paucity of comprehensive data on the feasibility and effectiveness of opioid free anaesthesia in laproscopic surgeries. hence we propose this study to report on the feasibility, efficacy and quality of recovery with an adapted opioid free anaesthesia protocol in subjects undergoing elective laproscopic cholecystectomy.
 
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