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To compare the time required to awaken patients with mild head injury undergoing non-head injury surgeries using infusion fentanyl versus lignocaine general anaesthesia

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 - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090756
Enrollment
42
Registered
2025-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S062- Diffuse traumatic brain injury Health Condition 2: S063- Focal traumatic brain injury Health Condition 3: S065- Traumatic subdural hemorrhage Health Condition 4: S068- Other specified intracranial injuries

Interventions

Intervention1: 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 maintena
and propofol in titrating doses as per BIS monitor Control Intervention1: Total Intravenous Anaesthesia(TIVA) with Fentanyl and Propofol: TIVA with injection fentanyl 2mcg/kg of body weight bolus at
and propofol in titrating doses as per BIS monitor

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To compare the time to awakening between groups receiving opioid vs non-opioid Total Intravenous AnaesthesiaTimepoint: From Time of skin closure to MOAS/S Score of more than 3—

Secondary

MeasureTime frame
To compare FOUR scoreTimepoint: at time of awakening;To compare GCS,VAS and percentage of patients having MOAA/S score of more than 3Timepoint: 30minutes after shifting to PACU;To compare Modified Aldrete Score in PACUTimepoint: time of shifting of patient;incidence and severity of nausea and vomittingTimepoint: ;incidences of adverse effects (hypotension, bradycardia, arrythmia)Timepoint:—

Countries

India

Contacts

Public ContactDr Amarjyoti Hazarika

PGIMER,Chandigarh

amarjyotiorama@gmail.com9990238972

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026