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CTRI Number  CTRI/2024/05/068114 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison between opioid-free anaesthesia and opioid-based anaesthesia for laparoscopic tubal ligation 
Scientific Title of Study   Comparison between opioid-free anaesthesia and opioid-based anaesthesia for laparoscopic tubal ligation- A non-inferiority randomized double-blind controlled trial  
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 Priyanka 
Designation  Post graduate 
Affiliation  University college of medical science and GTB hospital 
Address  Department of anaesthesiology, UCMS and GTB Hospital, Dilshad garden

North East
DELHI
110095
India 
Phone  7827067774  
Fax    
Email  sinha6659@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka 
Designation  Post graduate 
Affiliation  University college of medical science and GTB hospital 
Address  Department of anaesthesiology, UCMS and GTB Hospital, Dilshad garden

North East
DELHI
110095
India 
Phone  7827067774  
Fax    
Email  sinha6659@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetanjali T Chilkoti 
Designation  Professor 
Affiliation  University college of medical science and GTB hospital 
Address  Department of anaesthesiology and critical care,University college of medical science and GTB hospital

East
DELHI
110095
India 
Phone  09711210772  
Fax    
Email  geetanjalidr@yahoo.in  
 
Source of Monetary or Material Support  
Main ICU, Second floor, University college of medical science and GTB Hospital, Dilshad garden , New Delhi 110095, India 
 
Primary Sponsor  
Name  UCMS and GTB Hospital 
Address  Department of anaesthesiology, 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 Priyanka  University college of medical science and GTB Hospital  Main ICU second floor, Department of anaesthesiology and critical care, OT block, University college of medical science and GTB Hospital, Dilshad garden
East
DELHI 
7827067774

sinha6659@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution 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: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, (3) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GROUP OB Opioid Based  Patients will receive the standard opioid-based anaesthesia using bolus doses of inj fentanyl as per standard protocol. 
Intervention  Group OF Opioid Free  Patients in this group will receive inj. Magnesium sulphate 40mg/kg in 100 ml of saline over 15 minutes (without exceeding 2.5gm) before induction of anaesthesia. Patients will receive inj. Dexamethasone 0.1 mg/kg (diluted making a total volume of 4 ml) after induction of anaesthesia. anaesthesia will be as per standard protocol. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Consenting ASA Physical Status I – II female patients undergoing laparoscopic tubal
ligation under general anaesthesia. 
 
ExclusionCriteria 
Details  BMI more than 35
Known case of allergy to opioids or to adjuvant drugs
Patients with a history of postoperative nausea or vomiting
Patients with history of chronic pain of any aetiology or patients who are already on
opioids
Patients having cognitive dysfunction with inability to comprehend questionnaires.  
 
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 
AUC- NRS Pain score in 24 hours   from the time of shifting
the patient from Operation theatre to post-operative area till the completion of 24 hr  
 
Secondary Outcome  
Outcome  TimePoints 
1 Pain intensity using NRS Pain at Rest (NRS-R) & Movement (NRS-M)
2 Rescue analgesic consumption in the first 24 h
3 PONV score
4 Rescue antiemetic consumption in the first 24 h
5 Time to Aldrete score more than or equal to 9
6 Quality of Recovery (QoR-15) score

 
1 Pain intensity using NRS Pain at Rest (NRS-R) & Movement (NRS-M) at the end of 3rd 6th 12th & 24th hr
2 Rescue analgesic consumption in the first 24 h
3 PONV score at at the end of 3rd 6th 12th & 24th hr
4 Rescue antiemetic consumption in the first 24hr
5 Time to Aldrete score more than or equal to 9 measure from the time of shifting the patient to post operative area
6 Quality of Recovery (QoR-15) score at the end of 24 hrs

 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 4 
Date of First Enrollment (India)   10/06/2024 
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="3"
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  

Opioids are frequently utilized under anaesthesia; however, they are associated with side effects that includes nausea, vomiting, hypotension, respiratory depression/apnoea, bradycardia, somnolence, urinary retention, and constipation, cancer recurrence etc. In recent years, the concept of opioid-free anaesthesia (OFA) has emerged. Opioid-free anaesthesia has been found to be as efficacious as conventional opioid-based anaesthesia (OBA) in terms of decreased incidence of PONV and pain management. Laparoscopic tubal ligation is a common day care laparoscopic gynaecological procedure where OFA protocol may be of greater benefit as these patients are discharged on the same day and avoiding opioids related adverse events with the use of OFA protocol may significantly improve QoR in these patients.  Hence this study has been designed with the aim to evaluate and compare the efficacy of OFA and OBA in day care laparoscopic tubal ligation. Patients will be randomly allocated into one of the two groups. Group OB will receive GA using IV fentanyl under standard institutional protocol and Group OF will   group will receive magnesium sulphate 40mg/kg in 100 ml of saline over 15 minutes (without exceeding 2.5gm) before induction of anaesthesia and inj. dexamethasone o.1 mg/kg after induction of anaesthesia. The primary outcome is AUC- NRS Pain score in 24 hours. The secondary outcomes are Pain intensity using NRS Pain at Rest (NRS-R) and Movement (NRS-M) at 0-3h, 3-6 h, 6- 12 h, 12 -24 h, Rescue analgesic consumption in the first 24 h, PONV score at 0-3h, 3-6 h, 6-12 h and 12-24 h, Rescue antiemetic consumption in the first 24 h, Intraoperative and postoperative haemodynamic, Time to Aldrete score ≥ 9, Quality of Recovery (QoR-15) score, and adverse events like constipation, urinary retention, nausea, vomiting etc.

 

 

 
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