| CTRI Number |
CTRI/2025/05/087495 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess outcomes in patient posted for surgery - with or without opioids as a part of general anaesthesia |
|
Scientific Title of Study
|
Evaluating post operative outcomes with opioid free versus opioid inclusive general anaesthesia for elective surgeries : A randomized clinical trail |
| 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 Akansha Lata |
| Designation |
Junior resident |
| Affiliation |
AIIMS , Nagpur |
| Address |
Department of anaesthesia and critical care , All India Institute of medical sciences , Nagpur
Maharashtra
441108
India
Nagpur
MAHARASHTRA
441108
India |
| Phone |
6397850633 |
| Fax |
|
| Email |
akanshalata00006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrusha Raipure |
| Designation |
Additional professor |
| Affiliation |
AIIMS , Nagpur |
| Address |
Department of anaesthesia and critical care , All India Institute of medical sciences , Nagpur
Maharashtra
Nagpur
MAHARASHTRA
441108
India |
| Phone |
8888772200 |
| Fax |
|
| Email |
dramrusha@aiimsnagpuredu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrusha Raipure |
| Designation |
Additional professor |
| Affiliation |
AIIMS , Nagpur |
| Address |
Department of anaesthesia and critical care , All India Institute of medical sciences , Nagpur
Maharashtra
Nagpur
MAHARASHTRA
441108
India |
| Phone |
8888772200 |
| Fax |
|
| Email |
dramrusha@aiimsnagpuredu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science , Dahegaon , MIHAN , Nagpur , PINCODE 441108 |
|
|
Primary Sponsor
|
| Name |
Akansha lata |
| Address |
Department of Anaesthesiologist
IPD Building All
India Institute Of Medical Sciences
MIHAN
Dahegaon
Nagpur
Maharashtra
India 441108 |
| Type of Sponsor |
Other [Self] |
|
|
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 Akansha Lata |
All India Institute of Medical Science , Nagpur |
Department of anaesthesia and critical care , All India Institute of medical sciences , Nagpur
Maharashtra
441108
India
Nagpur
MAHARASHTRA |
06397850633
akanshalata00006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee department of pharmacology AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K819||Cholecystitis, unspecified, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: N809||Endometriosis, unspecified, (5) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (6) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, (7) ICD-10 Condition: N849||Polyp of female genital tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group OBA Patients received OBA with fentanyl.
|
Patient will be premedicated with Midazolam – 0.03 mg/kg IV, Fentanyl – 2 mcg/kg IV. Induction will be done using Propofol 2 mg/kg IV followed by muscle relaxant vecuronium 0.1mg/kg IV. The patient will be intubated with an appropriate size endotracheal tube. If the surgery lasts more than 2 hrs, repeat dose of fentanyl 1mcg/kg IV will be given |
| Intervention |
Group OFA Patients received OFA with lignocaine, diclofenac and MgSO4. |
• Patient will be premedicated with Midazolam – 0.03 mg/kg IV and inj Lignocaine 1 mg/kg before intubation. Inj MgSO4 1gm in 100 ml over 30 mins will be started. Inj Diclofenac 75 mg over 20 mins will be given.
• Induction will be done using Propofol 2 mg/kg IV followed by muscle relaxant vecuronium 0.1mg/kg IV. The patient will be intubated with an appropriate size endotracheal tube.
• Repeat lignocaine 1mg/kg at insufflation/ incision.
• SOS Dexmedetomidine 1 mcg/kg bolus f/b 0.5 mcg/kg/hr for the duration of the procedure if required in case of hypertensive response, to maintain the haemodynamics within 20% of the baseline.
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Aged greater than 18 years
Booked for elective laparoscopic or superficial surgeries
American Society of Anaesthesiologists physical status grade I-II
Surgeries lasting less than 3 hrs
|
|
| ExclusionCriteria |
| Details |
Pregnant women
Body Mass Index greater than 35
Allergy to opioids
Allergy to adjuvant drugs
Persistent opioid use
Non elective surgery
Surgeries lasting more than 3 hrs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome
Pain parameters
Postoperative pain scores VAS scores (0-10)
2nd hr
8th hr
24hr
|
Primary outcome
Pain parameters
Postoperative pain scores VAS scores (0-10)
2nd hr
8th hr
24hr
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes
PONV
2HRS
8HRS
24HRS
PACU stay (hrs)
hospital Length of stay (days)
Anaesthetist satisfaction (0-10)
|
Secondary outcomes
PONV
2HRS
8HRS
24HRS
PACU stay (hrs)
hospital Length of stay (days)
Anaesthetist satisfaction (0-10)
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
21/06/2025 |
| 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="6"
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
|
Opioid free anaesthesia is a technique where the intraoperative use of systematic , neuraxial or intracavitary opioid is completely eliminated . restricting opioid use in anaesthesia has shown variable effectiveness in different surgeries and patient population . whereas on one hand , the opioid consumption is reduced intraoperatively, effective nociception and reduction in postoperative opioid consumption is still under investigation with OFA. The commonly used armamentarium of non opioid analgesia includes local anaesthetics , clonidine , dexmedetomidine, ketamine , gabapentin , magnesium sulphate and dexamethasone The spectrum of opioid free anaesthesia can be of prime utility in patient at high risk of opioid related respiratory complication such as patient with obstructive sleep apnoea , patient posted for bariatric surgeries and patient with pulmonary limitation including obstructive airway diseases Opioid free anaesthesia also offer particular advantages in opioid tolerant patient such as patient with chronic pain , cancer related pain and patient suffering from opioid addiction . |