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The BALANCED Anaesthesia Study

NCT ID: NCT02073357

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Effect of General Anesthetic Dose on Recovery From Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Light general anaesthesia (BIS = 50)

Light general anaesthesia

Group Type EXPERIMENTAL

Light general anaesthesia (BIS = 50)

Intervention Type PROCEDURE

deep general anaesthesia (BIS = 35)

deep general anaesthesia

Group Type EXPERIMENTAL

deep general anaesthesia (BIS = 35)

Intervention Type PROCEDURE

Interventions

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Light general anaesthesia (BIS = 50)

Intervention Type PROCEDURE

deep general anaesthesia (BIS = 35)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Sessler

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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13-1195

Identifier Type: -

Identifier Source: org_study_id