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Assessment of Intraoperative Awarness during surgical procedure

Assessment of Intraoperative Awareness with Explicit Recall: A Comparison of Two Methods

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/07/015093
Enrollment
2000
Registered
2018-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 2: K90-K95- Other diseases of the digestive system

Interventions

Intervention1: BI-spectral index ( BIS)- GA will be monitored and controlled with BIS: BIS group the anaesthesiologist will be blinded to ETAG and MAC readings, in the ETAG group BIS display will be t

Sponsors

Director Prof Jagat ram PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female gender Aged 18-65 yrs. ASA Physical Status I/II General Anaesthesia Elective Surgery Surgery duration > 30-minutes Consenting for follow-up

Exclusion criteria

Exclusion criteria: Uncompensated systemic co-morbidity Cardiac and Neurosurgical procedures Head & Neck surgery Obstetric surgery Emergency surgery Anticipated difficult airway H/O brain injury, EEG abnormality Neuropsychiatry disorders Substance abuse (opioids, alcohol, recreational drugs, benzodiazepine) Pacemakers & Electronic implants Obesity (BMI >32kg/m2) Adhesive allergy

Design outcomes

Primary

MeasureTime frame
1.To assess the incidence of intraoperative awareness following inhalational GA Timepoint: 2yr

Secondary

MeasureTime frame
1. To profile BIS scores and end-tidal inhalation agent concentration in the study groups 2. Comparison Quality Assurance and prospective assessments of awareness incidence using Michigan Awareness Classification Instrument and modified Brice interview 3Incidence of PTSD 4time to eye opening upon verbal command, tracheal extubation after discontinuation of GA, for hospital discharge and Postoperative nausea and vomiting Timepoint: 2yr

Countries

India

Contacts

Public ContactShiv Lal Soni

PGIMER, Chandigarh

dr.shivsoni@gmail.com009914208550

Outcome results

None listed

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