Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

Chiang Mai University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Postoperative Delirium

Treatments: Device: Bispectral index, as measured by a BIS processor

Study type: Interventional

Funder types: Other

Identifiers

NCT02133430

ANE-2556-01778

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 65 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Bispectral index (BIS) group

Experimental group

Description:

Bispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60

Treatment:

Device: Bispectral index, as measured by a BIS processor

Control group

No Intervention group

Description:

Clinical signs is used to guide doses of anestheitics.