Optimized Anesthesia to Reduce Incidence of Postoperative Delirium in Elderly Undergoing Elective, Non-cardiac Surgery: a Randomized Controlled Trial (POD-II)

Chiang Mai University1 site in 1 country140 target enrollmentJanuary 2014

ConditionsPostoperative Delirium

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Postoperative Delirium
Sponsor: Chiang Mai University
Enrollment: 140
Locations: 1
Primary Endpoint: Number of patients have postoperative delirium
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

April 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chiang Mai University

Responsible Party

Principal Investigator

Dr. Yodying Punjasawadwong

Chiang Mai University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of patients have postoperative delirium

Time Frame: 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.