Cortisol as marker to assess stress response in Traumatic Brain Injury patients.

To assess stress response to propofol infusion vs. midazolam infusion in severe traumatic brain injury (TBI) patients measured by serum cortisol levels: A randomised control trial.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/022121

Enrollment

Registered

2019-11-22

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: V229- Unspecified motorcycle rider injured in collision with two- or three-wheeled motor vehicle in traffic accident

Interventions

Intervention1: sedative in Traumatic brain injury patients: propofol infusion vs midazolam infusion comparison in reducing stress response in TBI patients using cortisol as marker. Intervention2: seda

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients of 18years and above with GCS of 8 or less with an isolated head injury on ct finding requiring mechanical ventilation for more than 48hrs.

Exclusion criteria

Exclusion criteria: 1. refusal to give consent. 2.an elapsed time between trauma and icu admission of more than 24hrs. 3.gcs of 3 persistant from the scene with bilaterally dilated fixed pupils. 4.patients undergoing operation 5.patients on haemodynamic support. 6.patients whose baseline serum cortisol level is less than 15mg/dl

Design outcomes

Primary

Measure	Time frame
TO access if intravenous Propofol provides better obtundation of stress response due to traumatic brain injury as compared to Midazolam infusion when measured by change in serum cortisol levelsTimepoint: 3months follow up on 21/12/2019	—

Secondary

Measure	Time frame
1.To assess hemodynamic changes 2.To assess GCS, ONSD 3.To assess GOS 4.TO find out fentanyl requirement 5.To recored complication 6.To record additional therapyTimepoint: 48hrs after sedation	—

Countries

India

Contacts

Public ContactMallikarjun Kurni

PGIMER

amarjyoti28@rediffmail.com9990238972

Outcome results

None listed

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