| CTRI Number |
CTRI/2024/10/074828 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Opioid free vs opioid based anesthesia for supratentorial craniotomy |
|
Scientific Title of Study
|
A Randomised controlled single blinded trial to compare Opioid free anesthesia and Opioid based anesthesia in patients undergoing elective craniotomy for Supratentorial lesion
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bishnupriya Mohapatra |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Senior Resident , DM Neuroanesthesia , Department of Anesthesiology , Level 6, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249202
India |
| Phone |
8763330284 |
| Fax |
|
| Email |
bishnu.bishnupriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Agrawal |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Rishikesh |
| Address |
Professor and HOD, Department of Anesthesia , AIIMS Rishikesh
Dehradun
UTTARANCHAL
249202
India |
| Phone |
9761712630 |
| Fax |
|
| Email |
sanjay.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Agrawal |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Rishikesh |
| Address |
Professor and HOD, Department of Anesthesia , AIIMS Rishikesh
UTTARANCHAL
249202
India |
| Phone |
9761712630 |
| Fax |
|
| Email |
sanjay.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| department of Anesthesiology, 6th floor,AIIMS Rishikesh, Rishikesh,Uttarakhand PINCODE :249202 |
|
|
Primary Sponsor
|
| Name |
Dr Bishnupriya Mohapatra |
| Address |
Senior Resident ,DM Neuroanesthesia,Department of Anesthesiology,6th floor, AIIMS rishikesh ,Rishikesh,Uttarakhand,
PIN :249202 |
| 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 Bishnupriya Mohapatra |
AIIMS Rishikesh |
Department of Anesthesiology, level 6,AIIMS Rishikesh, Rishikesh, DEHRADUN, Uttarakhand PIN:249202
Dehradun
UTTARANCHAL |
8763330284
bishnu.bishnupriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS RISHIKESH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D330||Benign neoplasm of brain, supratentorial, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine infusion 0.5 µg/kg/hr from
induction till closure of dura. |
| Intervention |
fentanyl |
Fentanyl infusion at1µg/kg/hr starting from induction till
closure of dura . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient belonging to ASA I,II,III
Patients with pre operative GCS more than 14
Patient posted for elective supratentorial lesion |
|
| ExclusionCriteria |
| Details |
Patient posted for emergency craniotomy surgeries
3) Patient belonging to ASA IV and above
4) Patient with bradycardia (Heart rate <60 beats per minute)
5) Patient refusing to consent
6) Patient with chronic pain or on opioid medication
7) Patient with known allergy to study drugs
8) Patients with difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare duration to first rescue analgesic requirement in post operative period in
patients undergoing supratentorial craniotomy receiving opioid based anesthesia and
those receiving opioid free anesthesia |
To compare duration to first rescue analgesic requirement in post operative period in
patients undergoing supratentorial craniotomy receiving opioid based anesthesia and
those receiving opioid free anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative pain at 1,2,4,6,12 and 24 hours post operatively. |
at 1,2,4,6,12 and 24 hours post operatively. |
| total dose of rescue analgesic |
post operatively. |
incidence of side effects like bradycardia, tachycardia, hypotension ,
hypertension, post operative nausea vomiting , pruritus, respiratory depression |
post operatively. |
| total number of propofol bolus |
intra operatively. |
| compare quality of recovery (QoR- 15) score |
at 1, 6 ,12 , 24 hours post operatively
and at discharge |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
20/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 study was formulated to assess the utility and efficacy of opioid based and opioid free anesthesia in patients undergoing craniotomy for supratentorial lesions . Aim of the study is to compare the opioid free anesthesia technique to conventional opioid based technique in patients undergoing supratentorial craniotomy in patients for rescue analgesic requirement and pain scores |