Effect of General Anesthetic Dose on Recovery From SurgeryNCT02073357
The BALANCED Anaesthesia Study
A study testing Light general anaesthesia (BIS = 50) and deep general anaesthesia (BIS = 35) in people with Effect of General Anesthetic Dose on Recovery From Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Effect of General Anesthetic Dose on Recovery From Surgery
- What is being tested?
- Light general anaesthesia (BIS = 50) and deep general anaesthesia (BIS = 35)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Light general anaesthesia (BIS = 50), deep general anaesthesia (BIS = 35)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light general anaesthesia (BIS = 50)Procedure or surgery
deep general anaesthesia (BIS = 35)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Light general anaesthesia (BIS = 50) | Experimental | Light general anaesthesia Receives: Procedure: Light general anaesthesia (BIS = 50) |
| deep general anaesthesia (BIS = 35) | Experimental | deep general anaesthesia Receives: Procedure: deep general anaesthesia (BIS = 35) |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year all-cause mortality
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of General Anesthetic Dose on Recovery From SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Daniel Sessler, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073357
- Sponsor's protocol ID
- 13-1195
- Status last verified
- Jul 2014
- First submitted
- 25 Feb 2014
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BALANCED Anaesthesia Study A Prospective, Randomised Clinical Trial of Two Levels of Anaesthetic Depth on Patient Outcome After Major Surgery
- ClinicalTrials.gov ID
- NCT02073357
- Acronym / sponsor ID
- 13-1195
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Jul 2014
- Primary completion
- Jan 2019 (estimated)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light general anaesthesia (BIS = 50) | Experimental | Procedure: Light general anaesthesia (BIS = 50)Light general anaesthesia |
| deep general anaesthesia (BIS = 35) | Experimental | Procedure: deep general anaesthesia (BIS = 35)deep general anaesthesia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light general anaesthesia (BIS = 50) | Procedure or surgery | Light general anaesthesia (BIS = 50) |
| deep general anaesthesia (BIS = 35) | Procedure or surgery | deep general anaesthesia (BIS = 35) |
Primary outcome
One-year all-cause mortality
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Sessler principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light general anaesthesia (BIS = 50) and deep general anaesthesia (BIS = 35) in people with Effect of General Anesthetic Dose on Recovery From Surgery, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year all-cause mortality (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.