| 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
|
|
|
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
|
|
|
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. |