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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).

To evaluate the dose requirement of propofol for induction of anaesthesia in patients with traumatic brain injury using bilateral Bispectral Index

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/05/013682
Enrollment
90
Registered
2018-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients with traumatic brain injury coming for surgery Health Condition 2: S065- Traumatic subdural hemorrhage

Interventions

Intervention1: NIL: NIL

Sponsors

National Institute of Mental Health And Neurosciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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. 3. To determine the difference between preoperative and postoperative BIS 4.The difference between preoperative and postoperative BIS and its correlation with short term outcome (GOSE). Timepoint: 1.At the beginning of induction. 2. At the end of the anaesthetic induction. 3. At the end of the surgical procedure. 4.At the end of 30 days from recruitment

Countries

India

Contacts

Public ContactDr Seham Syeda

National Institute of Mental Health And Neurosciences

n_bhadri@yahoo.com9448084257

Outcome results

None listed

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