To know the dosage of drug(propofol)needed to anaesthetise a patient with head injury coming for surgery with help of a monitor called bilateral BIS ( bispectral index).

Completed

• Conditions: Traumatic subdural hemorrhage,

• Registration Number: CTRI/2018/05/013682
• Lead Sponsor: National Institute of Mental Health And Neurosciences

Brief Summary

Previous studies have demonstrated a decreased requirement of propofol in patients undergoing neurosurgical procedures as compared to non-neurological procedures. However, there is a paucity of literature with regard to the anaesthetic requirements in patients with TBI       We conducted this study  to determine the dose requirement of propofol for induction of anaesthesia in patients with TBI undergoing surgery, using a bilateral BIS monitor. Methodology: 90 patients of either sex with mild , moderate and severe head injury coming for surgery within 48 hrs of trauma will be enrolled in this study. Dose requirement of propofol in order to reduce the value of BIS to less than or equal to 40 on the uninjured side using Schnider module on target controlled infusion (TCI) pump will be determined in each group of patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-17
• Study Completion: 2018-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients of either sex, aged between 18- 60 years with mild, moderate and severe traumatic brain injury (TBI) presenting for surgery within 48 hours of trauma .

Exclusion Criteria

Patients who are hemodynamically unstable, patients with relative refusing to give consent, patients in whom BIS recording is not possible, patients with anticipated difficult airway, patients history of severe cardiac, pulmonary, liver or renal disease, or obesity (body mass index >30) and pregnancy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the dose requirement of propofol for induction of anaesthesia in patients with TBI undergoing surgery using bilateral BIS.	At the end of induction , when BIS value decreases to less than or equal to 40 on the uninjured side.

Secondary Outcome Measures

Name	Time	Method
1.To determine the baseline BIS on the injured and non-injured side in all patients of TBI undergoing surgery	2. To determine the difference in propofol requirement in male and female patients with TBI.

Trial Locations

Locations (1)

National Institute of Mental Health And neurosciences; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Mental Health And neurosciences

🇮🇳Bangalore, KARNATAKA, India

Dr Seham Syeda

Principal investigator

9886094357

sehamsyeda@gmail.com