Optimized Anesthesia to Reduce Incidence of Postoperative Delirium

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02133430
• Other study ID #: ANE-2556-01778
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 2, 2014
• Last updated: May 8, 2014
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2014
• Source: Chiang Mai University
• Contact: Dr. Yodying Punjasawadwong, MD
• Phone: +66819928082
• Email: typunja[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Device:
• Bispectral index, as measured by a BIS processor
Comparisons of incidence of postoperative delirium.

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of Medicine, Chiang Mai University	Maung	Chiang Mai

Sponsors (2)

Lead Sponsor	Collaborator
Chiang Mai University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients have postoperative delirium	Assess postoperative delirium by using Confusion Assessment Method for intensive care unit (CAM-ICU) at recovery room and Confusion Assessment Method at inpatient ward.	Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.	No
Secondary	Number of patients with impaired cognitive function	Assessed postoperative cognitive function by using Mini-Mental State Examination and Montreal Cognitive Assessment (MoCA) .	Up to 6 months	No
Secondary	Time to recovery	Time between end of anesthesia and eye opening, spontaneous breathing, and extubation.	The end of surgery	No

External Links

•   Sponsor's website