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

NCT03480880 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-29

No results posted yet for this study

Summary

This study was conducted in two parts:

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. 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

Interventions

DEVICE

Bispectral Index

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.

Sponsors & Collaborators

  • National Institute of Mental Health and Neuro Sciences, India

    lead OTHER

Principal Investigators

  • Muthuchellappan Radhakrishnan, MD, DM · National Institute of Mental Health and Neuro Sciences, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2017-05-30
Completion
2017-06-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03480880 on ClinicalTrials.gov