Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

Phase 2

• Conditions: Postoperative Delirium
• Interventions: Device: Bispectral index, as measured by a BIS processor

• Registration Number: NCT02133430
• Lead Sponsor: Chiang Mai University

Brief Summary

The purpose of this study is to compare the difference of incidence of postoperative delirium between patients received general anesthesia guided by Bispectral index (BIS) and patients received general anesthesia using standard technique.

Detailed Description

General anesthesia is one of precipitating factor of postoperative delirium which Its mechanism is still unknown. General anesthesia can affect on pattern of electroencephalograph. Previous studies showed that patients received BIS guided anesthesia could wake up faster, earlier extubation and stay in recovery room shorter compared to standard general anesthesia. Optimized level of anesthesia by BIS could reduce cognitive dysfunction in elderly patients and reduce biological marker of brain injury. Therefore, the investigators hypothesized that adjustment of general anesthesia by BIS guided could protect central nervous system and reduce incidence of postoperative delirium.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-05
• Study First Submitted: 2014-05-02
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-12
• Primary Completion: 2015-02
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients age equal or more than 65 years.
• Patients undergoing general anesthesia.
• Patients undergoing scheduled, non-cardiac surgery

Exclusion Criteria

• Patients undergoing neurosurgery.
• Patients cannot understand Thai language.
• Patients who have severe visual or hearing impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bispectral index (BIS) group	Bispectral index, as measured by a BIS processor	Bispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60

Primary Outcome Measures

Name	Time	Method
Number of patients have postoperative delirium	Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.	Assess postoperative delirium by using Confusion Assessment Method for intensive care unit (CAM-ICU) at recovery room and Confusion Assessment Method at inpatient ward.

Secondary Outcome Measures

Name	Time	Method
Time to recovery	The end of surgery	Time between end of anesthesia and eye opening, spontaneous breathing, and extubation.
Number of patients with impaired cognitive function	Up to 6 months	Assessed postoperative cognitive function by using Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA) .

Trial Locations

Locations (1)

Department of Anesthesiology, Faculty of Medicine, Chiang Mai University; 🇹🇭 Maung, Chiang Mai, Thailand