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The BALANCED Anaesthesia Study

NCT02073357 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-07-31

No results posted yet for this study

Summary

General anaesthesia is a reversible drug-induced coma. Too little can result in patients being partially conscious during surgery; too much can slow recovery after surgery. There is a range of drug doses that can be used and some anesthesiologists use more than others. There is no convincing evidence that any particular dose within the usual range is better. Consequently, there are no guidelines on the best depth of anaesthesia. This study will determine whether general anesthetic concentrations at the low end of the usual range are better than those at the high end.

Participants will randomly be assigned to lighter or deeper general anesthesia. The first day after surgery, two short questionnaires about recovery and memories of the surgery will be completed. During the rest of the participant's hospital stay, a survey about how one feels will be completed.

There will be two telephone contacts after discharge from the hospital. One month after surgery three questionnaires will be completed about performing daily tasks, how you feel and memories of the surgery. Then one year after surgery pain will be assessed.

Conditions

  • Effect of General Anesthetic Dose on Recovery From Surgery

Interventions

PROCEDURE

Light general anaesthesia (BIS = 50)

PROCEDURE

deep general anaesthesia (BIS = 35)

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Daniel Sessler · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2019-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073357 on ClinicalTrials.gov