Recovery From General Anesthesia

NCT00165971 | Completed

• 2 other identifiers: 459-200319907000
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia allows people to have surgery without experiencing the procedure or pain. To remain unconscious, the depth of sleep must be monitored. Various monitors have been developed, one of which is BIS (short for bispectral index). BIS monitors the level of sleep during anesthesia and improves patient recovery because the amount of sleep drugs can be fine-tuned to the individual. Patients who need a lot to stay asleep get more, and those who need less get less. As a result, patients tend to wake up faster with BIS monitoring as compared to standard practice not using BIS. Little is known about the long-term effects of BIS monitoring. This study investigates whether BIS monitoring during anesthesia improves long-term outcome, well after surgery is over. The hypothesis is that it does. Two groups of patients are compared: one in which BIS monitoring was used, and one in which it was not. Groups are compared on tests of memory, concentration and mental well-being, to see if one does and feels better than the other. The investigators also take blood samples to see how well patients' bodies deal with the surgery. The investigators expect the BIS monitoring group to do better.

Conditions

Anesthesia, General; Recovery Period, Anesthesia

Keywords

Cognitive decline; Inflammation; Monitoring; Recovery; Bispectral index

Outcome Measures

Primary Outcomes (2)

• Cognitive function

• Inflammation

Secondary Outcomes (3)

• Memory function

• Depression

• Anxiety

Interventions

BIS monitoring PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective hip or knee replacement surgery, primary or revisions, under general anesthesia

You may not qualify if:

• Drug allergies
• Recent illicit drug abuse
• Mental illness, or psychoactive medication treatment
• Head trauma resulting in loss of consciousness
• Neurological disorder
• Scheduled for cardiac surgery
• Memory disorders
• Severe visual or auditory handicap
• English is not the patient's first language
• Illiteracy.

Sponsors & Collaborators

• Emory University: lead
• CogState Ltd.: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Inflammation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter S Sebel, MB BS, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Chantal Kerssens, PhD

  Emory University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: December 1, 2003
• Study Completion: February 1, 2007
• Last Updated: April 17, 2007

Record last verified: 2007-04

Locations

US (1)