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CTRI Number  CTRI/2024/06/069510 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 23/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of anaesthesia with and without the use of opioids in patients undergoing middle ear surgery 
Scientific Title of Study   Comparison of efficacy of opioid-free anaesthesia with opioid-based anaesthesia in patients undergoing middle ear surgery:a randomised controlled 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 Aditya 
Designation  Post graduate resident 
Affiliation  University College Of Medical Sciences and GTB Hospital 
Address  Main ICU,Second Floor,Department Of Anaesthesiology,UCMS and GTB Hospital,Dilshad Garden

East
DELHI
110095
India 
Phone  8800507657  
Fax    
Email  raoaditya83@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aditya 
Designation  Post graduate resident 
Affiliation  University College Of Medical Sciences and GTB Hospital 
Address  Main ICU,Second Floor,Department Of Anaesthesiology,UCMS and GTB Hospital,Dilshad Garden


DELHI
110095
India 
Phone  8800507657  
Fax    
Email  raoaditya83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetanjali T Chilkoti 
Designation  Professor 
Affiliation  University College Of Medical Sciences and GTB Hospital 
Address  Main ICU,Second Floor,Department Of Anaesthesiology,UCMS and GTB Hospital,Dilshad Garden

East
DELHI
110095
India 
Phone  9711210772  
Fax    
Email  geetanjalidr@yahoo.co.in  
 
Source of Monetary or Material Support  
Main Icu, Second floor, University College of medical sciences and Guru Teg Bahadur Hospital, Dilshad Garden New Delhi, India. Pin-110095 
 
Primary Sponsor  
Name  University College of medical sciences and GTB Hospital  
Address  Department of Anesthesiology, University College of medical sciences and GTB Hospital, Dilshad garden, 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 Aditya  University College of medical sciences and GTB Hospital  Second floor, ICU block Department of anaesthesiology, UCMS and GTB Hospital,Dilshad Garden,Delhi
East
DELHI 
8800507657

raoaditya83@gmail.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: H662||Chronic atticoantral suppurative otitis media, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group OB (Opioid Based)  Patients will receive the standard opioid-based anaesthesia with I.V Fentanyl at an induction dose of 2 mcg/kg via intravenous route and an additional 1 mcg/kg I.V Fentanyl will be administered every 1.5 hour till the end of the surgery. 
Intervention  Group OF (Opioid-Free)  Patients will receive non-opioid drugs intraoperatively i.e. dexmedetomidine infusion via intravenous route pre-induction at 0.5mcg/kg over 10 minutes and then at the rate of 0.3-0.7 mcg/kg/hr and ketamine infusion via intravenous route at the rate of 0.25-0.5 mg/kg/hr post-induction of anaesthesia till the end of the surgery. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Consenting ASA grade I – II patients, aged 20-60 years, undergoing middle surgeries. 
 
ExclusionCriteria 
Details  Patients with a history of PONV.
Patients with history of chronic pain of any etiology 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 Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of PONV using PONV score  At the end of 12th hour 
 
Secondary Outcome  
Outcome  TimePoints 
1 Incidence of PONV

2 Pain intensity using NRS Pain at Rest & Cough

3 Total rescue analgesic consumption in the first 24 hours

4 Total rescue antiemetic consumption in the first 24 hours


5 Time to Aldrete score more than or equal to 9 (in mins)

6 QoR-15 score at the end of 24 hrs
 
1 Incidence of PONV at various time points at the end of 3rd 6th 12th 24th & 48th hr

2 Pain intensity using NRS Pain at Rest & Cough at the end of 3th 6th 12th 24th & 48th hr

3 Total rescue analgesic consumption in first 24 hours

4 Total rescue antiemetic consumption in first 24 hours

5Time to Aldrete score more than or equal to 9 (in mins) & wlll be recorded from the time patient is shifted to postoperative area from operation theatre

6 QoR-15 score at the end of 24 hrs
 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   10/07/2024 
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, constipation and 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 post-operative nausea and vomiting (PONV) and comparable pain management. On literature search, no study has evaluated strict OFA regimen for middle ear surgery. Patients will be randomly allocated into one of the two groups. Patients in group OB will receive conventional opioid-based anaesthesia. Patients in group OF will receive opioid-free anaesthesia. For providing OFA, patients will receive dexmedetomidine infusion pre-induction at 0.5 mcg/kg over 10 minutes and then at the rate of 0.3-0.7mcg/kg/hr. Ketamine at the rate of 0.25-0.5mg/kg/hr will be administered intravenously for providing analgesia and hemodynamic stability during surgery. The infusions will be stopped approx. 30 mins before completion of surgery. The primary outcome is incidence of PONV in 0-12 h time interval. The secondary outcomes are  PONV at 0-6th hr, 6th -12th hr, 12th -24th hr and 24th-48th hr between the two groups, Severity of PONV using Nausea score at 0-48 h, Pain intensity using NRS-Pain at Rest and Cough at 0-3 h,3-6 h, 6-12 h, 12-24 h, 24-48 h, Total rescue antiemetics consumption in the first 24 hours, Rescue analgesic consumption in the first 24 hours, QoR-15 score,intraoperative and post-operative haemodynamic parameters, Time to Aldrete score ≥9, Adverse events like constipation, urinary retention, pruritus, postoperative ileus etc.

 

                                

 
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