| CTRI Number |
CTRI/2025/07/090756 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| 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
|
To compare the time required to awaken patients with mild head injury undergoing non-head injury surgeries using infusion fentanyl versus lignocaine general anaesthesia |
|
Scientific Title of Study
|
To compare time to awakening of patients with mild traumatic head injury undergoing non-neurosurgical surgery with and without opioid-based general anaesthesia : a randomised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shinjini Chakraborty |
| Designation |
Junior Resident Doctor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia, PGIMER, Sector 12, Madhya Marg, Chandigarh-160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8100968157 |
| Fax |
|
| Email |
bristi.saltlake@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarjyoti Hazarika |
| Designation |
Additional Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Anaesthesiology Post Graduate Institute of Medical Education and Research, Madhya Marg, Sector 12, Chandigarh 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9990238972 |
| Fax |
|
| Email |
amarjyotiorama@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarjyoti Hazarika |
| Designation |
Additional Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Anaesthesiology Post Graduate Institute of Medical Education and Research, Madhya Marg, Sector 12, Chandigarh 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9990238972 |
| Fax |
|
| Email |
amarjyotiorama@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia, Nehru Block, Post Graduate Institute of Medical Education and Research, Sector 12, Madhya Marg, Chandigarh-160012 |
| 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 Shinjini Chakraborty |
Postgraduate institute of medical education and researchOT |
Dept of Anaesthesia and intensive care, 4th floor
nehru building PGIMER,sectorn12
Chandigarh
CHANDIGARH |
8100968157
bristi.saltlake@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, (2) ICD-10 Condition: S063||Focal traumatic brain injury, (3) ICD-10 Condition: S065||Traumatic subdural hemorrhage, (4) ICD-10 Condition: S068||Other specified intracranial injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Total Intravenous Anaesthesia (TIVA) with Lignocaine and Propofol |
TIVA with injection Lignocaine bolus of 2mg/kg at induction followed by Lignocaine infusion at 2 mg/kg/hr for maintenance ; and propofol in titrating doses as per BIS monitor |
| Comparator Agent |
Total Intravenous Anaesthesia(TIVA) with Fentanyl and Propofol |
TIVA with injection fentanyl 2mcg/kg of body weight bolus at induction followed by 2mcg/kg/hr infusion for maintainence ; and propofol in titrating doses as per BIS monitor |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Polytrauma patients with mild traumatic brain injury with baseline GCS of more than or equal to 13/15, M status of 6 and baseline BIS value of more than or equal to 85 posted for non-neurosurgical surgeries within 24 hours of their injury.
b. patients with positive CT findings.
c. duration of surgery less than 4 hours.
d. patients or their relatives giving informed consent. |
|
| ExclusionCriteria |
| Details |
a. Polytrauma patients exceeding age limit
b. Baseline GCS less than 13 or baseline BIS value less than 85
c. Any contraindication to lignocaine use.
d. preoperative hypothermia.
e. dyselectrolytemia
f. Patients not requiring general anaesthesia.
g. patients or their relatives not giving consent.
h. expected duration of surgery more than 4 hours.
i. pregnant patients.
j. patients undergoing spine surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time to awakening between groups receiving opioid vs non-opioid Total Intravenous Anaesthesia |
From Time of skin closure to MOAS/S Score of more than 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare FOUR score |
at time of awakening |
| To compare GCS,VAS and percentage of patients having MOAA/S score of more than 3 |
30minutes after shifting to PACU |
| To compare Modified Aldrete Score in PACU |
time of shifting of patient |
| incidence and severity of nausea and vomitting |
|
| incidences of adverse effects (hypotension, bradycardia, arrythmia) |
|
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
Traumatic Brain Injury patients often undergo emergency non-neurosurgical surgeries. Traumatic brain Injury compromises the cerebral physiology. The preferred mode of anaesthesia for TBI patients undergoing surgeries is Total Intravenous Anaesthesia using an intravenous anaesthetic agent such as propofol and an opioid such as fentanyl. The opioids( such as fentanyl) used in TIVA is known to cause sedation and prolongation of awakening of patients thereby hampering the serial assessment of GCS. Non opioid TIVA is used in a broad spectrum of surgical cases and pathologies. However there is a dearth of literature on the effects of non-opioid TIVA on TBI patients undergoing non-neurosurgical surgeries. |