The BALANCED Anaesthesia Study

The BALANCED Anaesthesia Study A Prospective, Randomised Clinical Trial of Two Levels of Anaesthetic Depth on Patient Outcome After Major Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Effect of General Anesthetic Dose on Recovery From Surgery
• Intervention / Treatment: Procedure: Light general anaesthesia (BIS = 50); Procedure: deep general anaesthesia (BIS = 35)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥60 years
• ASA physical status 3 or 4
• surgery expected to last ≥2 hours
• post-operative hospital stay expected to be ≥2 nights
• general anaesthesia with or without major regional block
• able to monitor BIS throughout anaesthesia

Exclusion Criteria:

• Unable to monitor BIS (e.g. cranial or intracranial surgery)
• unable to consent
• surgery with 'wake-up' test
• propofol infusion for part or all of maintenance of anaesthesia ('total intravenous anaesthesia')
• previous enrolment in Balanced study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light general anaesthesia (BIS = 50); Light general anaesthesia	Procedure: Light general anaesthesia (BIS = 50)
Experimental: deep general anaesthesia (BIS = 35); deep general anaesthesia	Procedure: deep general anaesthesia (BIS = 35)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
One-year all-cause mortality	One year

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: National Health and Medical Research Council, Australia
• Investigators: Principal Investigator: Daniel Sessler, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 13-1195