Study to Determine if Patients Exposed to General Anesthesia Significant Numbers of Times Would Increase the Risk for Intraoperative Awareness.

NCT05857618 | Active Not Recruiting

• 1 other identifier: IRB 17-0929
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study will detect whether prior exposure to general anesthesia multiple times is associated with an increased incidence of awareness with explicit recall (AWR). This is especially important because patients who need to undergo multiple events of general anesthesia are medically some of the most vulnerable populations. The study hypothesizes that patients with significant exposure to general anesthesia have a higher incidence of AWR. This study may help clinicians and patients to better understand how to manage anesthesia care so that the safety and comfort of patients can be improved.

Conditions

General Anesthesia; Intraoperative Awareness

Keywords

explicit recall; Intraoperative; Intraoperative awareness; General Anesthesia; Intraoperative recall

Outcome Measures

Primary Outcomes (1)

• Intraoperative Awareness with Explicit Recall for patients who underwent more than 20 general anesthesia events

  The Number of incidences of intraoperative awareness with explicit recall with patients undergoing general anesthesia greater than 20 times using the 5-question modified Brice questionnaire

  Until study completion; up to 1 year.

Secondary Outcomes (1)

• Intraoperative Awareness with Explicit Recall for patients who underwent less than 5 general surgeries involving general anesthesia

  Until study completion; up to 1 year.

Study Arms (1)

Patients who have undergone exposer to General Anesthesia

Patients who have undergone general anesthesia at the University of Chicago Medical Center more than 20 times or patients who have general anesthesia 5 or fewer times in the past.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from the University of Chicago Medical Center who are 7 years or older who have been exposed to general anesthesia either less than 5 times or greater than 20 times.

You may qualify if:

• Patients who have been exposed to general anesthesia greater than 20 times or who have been exposed to general anesthesia 5 or fewer times between January 1, 1985 and June 15, 2017
• Patients/their Guardians who consent to participate in the study.
• Patients for whom a determination of AWR status can be made by anesthesiologists based on a standardized criteria.
• Must be at least 7 years of age or older.

You may not qualify if:

• Healthy volunteers,
• Patients who cannot recall whether or not they have experienced intraoperative awareness with explicit recall

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: May 12, 2023
• Study Start: July 19, 2017
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)