Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients

NCT03480880 | Completed Phase 4

• 1 other identifier: NIMHANS/DO/103rd IEC/2016
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted in two parts:

1. 1.This first part was designed to determine thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index monitoring - Participant and Care Provider in appropriate study arm blinded.
2. 2.As a secondary outcome, Bispectral index monitoring was used to observe changes in neuronal function in intraoperative period as well as haemodynamic changes intraoperatively - Participant and Care Provider blinded.

Conditions

Traumatic Brain Injury

Keywords

Bispectral Index

Outcome Measures

Primary Outcomes (1)

• Thiopentone requirement

  Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients.

  Beginning of anaesthetic induction till End of anaesthetic induction

Secondary Outcomes (4)

• Intraoperative Bispectral Index changes

  Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.

• Intraoperative Systolic blood pressure changes

  Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.

• Intraoperative Mean blood pressure changes

  Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.

• Intraoperative heart rate changes

  Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.

Study Arms (2)

Group BIS

EXPERIMENTAL

Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.

Device: Bispectral Index

Group Clinical

NO INTERVENTION

Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus.

Interventions

Bispectral Index DEVICE

Thiopentone was administered in 50 mg boluses during induction of anaesthesia, until reduction of Bispectral Index value to less than 50, and total dose of thiopentone recorded.

Group BIS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Head injury patients coming for surgery

You may not qualify if:

• Hypotension/Arrythmias at time of induction
• Extra Dural Hemorrhage
• Extracranial injuries
• Scalp lacerations
• History of Seizures
• No consent

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Consciousness Monitors

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Muthuchellappan Radhakrishnan, MD, DM

  National Institute of Mental Health and Neuro Sciences, India

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 1. Anaesthetic care provider in one arm of first part of study was blinded to intraoperative changes in Bispectral index. 2. Anaesthetic care provider was blinded to Bispectral Index changes in second part of study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 1. Inj. Thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index guidance. 2. Observation of Bispectral Index change in intraoperative period.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: October 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: June 15, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share