| CTRI Number |
CTRI/2025/09/095164 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Opioid Free Anaesthesia (OFA): Fentanyl vs Ketodex, a randomised controlled study |
|
Scientific Title of Study
|
A single center, randomised controlled, double blinded clinical study on opioid free anaesthesia in patients undergoing minimally invasive abdominal and pelvic surgeries |
| 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 Balachandran |
| Designation |
Senior Consultant |
| Affiliation |
SIMS Hospitals |
| Address |
Department of anaesthesia and pain services
SIMS Hospitals, Metro Number 1, Jawaharlal Nehru Road, Vadapalani, Chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
9840680680 |
| Fax |
|
| Email |
balaab8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balachandran |
| Designation |
Senior Consultant |
| Affiliation |
SIMS Hospitals |
| Address |
Department of anaesthesia and pain services
SIMS Hospitals, Metro Number 1, Jawaharlal Nehru Road, Vadapalani, Chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
9840680680 |
| Fax |
|
| Email |
balaab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balachandran |
| Designation |
Senior Consultant |
| Affiliation |
SIMS Hospitals |
| Address |
Department of anaesthesia and pain services
SIMS Hospitals, Metro Number 1, Jawaharlal Nehru Road, Vadapalani, Chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
9840680680 |
| Fax |
|
| Email |
balaab8@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIMS hospitals
Department of anaesthesiology and pain services
Metro number 1, Jawaharlal Nehru road, next to Vadapalani metro, Vadapalani , Chennai 600026 |
|
|
Primary Sponsor
|
| Name |
SIMS Hospitals |
| Address |
Metro No 1, Jawaharlal Nehru Road, Vadapalani, Chennai 600026 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Balachandran |
SIMS hospitals department of anaesthesiology and pain services |
Metro number 1, Jawaharlal Nehru road next to Vadapalani metro, Vadapalani Chennai
Chennai
TAMIL NADU |
9840680680
balaab8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomine 100 mcg and ketamine 50 mg diluted with 48 ml of normal saline in a 50 ml syringe |
Run at infusion at induction at 120 ml per hour followed by reduction after 5 minutes to 5 ml per hour and titrated every 10 minutes based on hemodynamic response |
| Intervention |
Fentanyl |
Given at induction 2 mcg per kilo followed by 1 mcg per kilo every hour till end of procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of American society of anaesthesiology grade 1 and 2 Patients weighing between 40 and 80 kilos
All genders
Patients admitted for minimally invasive abdominal and pelvic surgeries Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients of American society of anaesthesiology grades 3 and above Pregnant and lactating women
Patients with allergies to any of the drugs- general and local anaesthetic agents being used Patients with h/o neuromuscular disorders, malignant hyperthermia or susceptible
individuals
Patients with any degree of heart block or with pacemaker
Minimally invasive surgeries getting converted to open surgeries Patients with anticipated possible difficult airway
Patients participating in any other clinical study
Patients not willing to participate in this study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare intraoperative combination of dexmedetomidine and ketamine (ketodex) with that of intraoperative fentanyl in terms of post operative analgesia by means of Visual Analogue Scale (VAS) |
Immediate post op, every hour till 6 hours postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor & quantify adverse effects of ketodex in terms of sedation, bradycardia, hypotension & emergence delirium
To quantify efficacy of analgesia of ketodex in terms of requirement of postoperative rescue analgesia |
postoperative period immediately & every hour till 6 hours post operative |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
20/10/2025 |
| 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="0"
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
|
this is a randomised controlled double blinded clinical study for the efficacy opioid free anaesthesia using a mixture of dexmedetomidine and ketamine as intraoperative infusion for the study group and intraoperative fentanyl as control group and compare the efficacy of opioid free anaesthesia and opioid anaesthesia in terms of postoperative pain and other side effects such as nausea, vomiting, confusion and emergence delirium |