ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2016/11/007432
Date of registration:	04-11-2016
Prospective Registration:	Yes
Primary sponsor:	Lady Hardinge Medical College
Public title:	Relationship between two depth of anaesthesia monitors- Bispectral Index and age adjusted MAC in general anaesthesia
Scientific title:	A Study of Relationship between Bispectral Index Values and Age Adjusted Minimum Alveolar Concentration during the Maintenance Phase of General Anaesthesia in Elective Surgery.
Date of first enrolment:	07-11-2016
Target sample size:	350
Recruitment status:	Open to Recruitment
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16364
Study type:	Observational
Study design:	Single Arm Trial Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
Phase:	N/A

Countries of recruitment
India

Contacts

Name:	Dr Nishant Kumar
Address:	Dept. of Anaesthesiology Lady Hardinge Medical College SSK Hospital Dept. of Anaesthesiology Lady Hardinge Medical College SSK Hospital 110001 New Delhi, DELHI India
Telephone:	9811934659
Email:	kumarnishant@yahoo.co.uk
Affiliation:	Lady Hardinge Medical College

Name:	Dr Nishant Kumar
Address:	Dept. of Anaesthesiology Lady Hardinge Medical College SSK Hospital Dept. of Anaesthesiology Lady Hardinge Medical College SSK Hospital 110001 New Delhi, DELHI India
Telephone:	9811934659
Email:	kumarnishant@yahoo.co.uk
Affiliation:	Lady Hardinge Medical College

Key inclusion & exclusion criteria

Inclusion criteria: ASA I and II undergoing elective surgery under general anaesthesia
Exclusion criteria: Patient refusal to participate in the study

Any emergency surgeries

Patients receiving total intravenous anaesthesia

If surgical procedure or positioning of patient prevents BIS monitoring.

Patients with history of stroke or with residual neurological deficits.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- ASA I & II patients undergoing elective surgery

Intervention(s)

Primary Outcome(s)

Correlation between BIS value and age adjusted MACTimepoint: every minute during maintenance phase of anaesthesia

Secondary Outcome(s)

Variables influencing BIS and age adjusted MAC

Equation between BIS and aaMAC

Timepoint: At the end of study

Secondary ID(s)

NIL

Source(s) of Monetary Support

Infrastructure provided by Lady hardinge Medical College

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 27/10/2016
Contact:

Institutional Ethical Committee

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.