Stabilizing Hypnotic Depth and Vital Sign During Balanced AnesthesiaNCT02283866

Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil

A study testing Administering desflurane according to the patient's BIS value and Administering desflurane at 1 MAC in people with Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia
What is being tested?: Administering desflurane according to the patient's BIS value and Administering desflurane at 1 MAC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteSouth Korea
Study dates: Jun 2014to Mar 2015
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 20 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients scheduled for operation under balanced anesthesia using desflurane and remifentanil

Who cannot join

Refusal of consent
General anesthesia with agents other than desflurane and remifentanil
Patients with allergy to neuromuscular blocker, volatile anesthetics, opioids
History of malignant hyperthermia
Patients taking CNS stimulants
Chronic alcohol abuser

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Patients with severe depressed left ventricular function, EF < 30%
Patients with convulsive disorders
ASA class IV, V, VI
Patients with systolic arterial blood pressure lower than 90mmHg before surgery
Patients needing inotropic infusion during surgery
Anesthesia time less than 30 minutes

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern anesthesia. The purpose of this study is to compare two methods of administering desflurane, an volatile anesthetic during balanced anesthesia. The investigators hypothesized that administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth than administering desflurane according to the patient's BIS (bispectral index) value.

Conditions: Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia
Being tested: Administering desflurane according to the patient's BIS value, Administering desflurane at 1 MAC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Administering desflurane according to the patient's BIS valueDrug
Administering desflurane according to the patient's BIS value
Administering desflurane at 1 MACDrug
Administering desflurane at 1 MAC

Study groups in NCT02283866
Study group	Role	What they receive
Administering desflurane according to the patient's BIS value	Experimental	The anesthesiologist administers the volatile anesthetic desflurane to set the patient's BIS value at 50 during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg. Receives: Drug: Administering desflurane according to the patient's BIS value
Administering desflurane at 1 MAC	Experimental	The anesthesiologist administers the volatile anesthetic desflurane at 1 MAC during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg. Receives: Drug: Administering desflurane at 1 MAC

What is being measured

The primary outcome is the main question the study is designed to answer.

The difference of 'wobble' value of the patients' BIS value between the two groups
'Wobble' is a variable that can measure the performance measurement of a pharmacokinetic model, or the reaction of the patient to a drug. We can calculate the performance error from the target of the therapy and the actual measured value, and derive the wobble by a specific formulas, which are described below.
PE=(BISmeasured-BIStargeted)x100/BIStargeted MDPEi = median{PEij, j=1,…,Ni} MDAPEi = median{|PEij|, j=1,…,Ni} Wobblei = median{|PEij-MDPEi|, j=1,…,Ni} Divergence = slope{|PEij|, j=1,…,Ni}
Measured: Every second from 10 minutes after skin incision to 10 minutes before surgery end.

Secondary outcomes (1)

The difference of 'wobble' value of the patients' systolic arterial blood pressure value between the two groups
Described above
Measured: Every 2.5 minutes from 10 minutes after skin incision to 10 minutes before surgery end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Mar 2015

First posted5 Nov 2014 (estimated)
Study startJun 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stabilizing Hypnotic Depth and Vital Sign During Balanced AnesthesiaStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02283866
Sponsor's protocol ID: CWJung_BA
Status last verified: Jul 2015
First submitted: 3 Nov 2014
Last updated: 15 Jul 2015
Results posted: No

Publications

Yang SM, Jung YS, Jung CW, Kim WH, Yoon SB, Lee HC. Comparison of bispectral index-guided and fixed-gas concentration techniques in desflurane and remifentanil anesthesia: A randomized controlled trial. PLoS One. 2020 Nov 5;15(11):e0241828. doi: 10.1371/journal.pone.0241828. eCollection 2020.
PubMed 33152029

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil
ClinicalTrials.gov ID: NCT02283866
Acronym / sponsor ID: CWJung_BA
Conditions: Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Jun 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 5 Nov 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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Administering desflurane according to the patient's BIS value	Experimental	Drug: Administering desflurane according to the patient's BIS valueThe anesthesiologist administers the volatile anesthetic desflurane to set the patient's BIS value at 50 during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg.
Administering desflurane at 1 MAC	Experimental	Drug: Administering desflurane at 1 MACThe anesthesiologist administers the volatile anesthetic desflurane at 1 MAC during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg.

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients scheduled for operation under balanced anesthesia using desflurane and remifentanil

Key exclusion criteria (12 listed)

Refusal of consent
General anesthesia with agents other than desflurane and remifentanil
Patients with allergy to neuromuscular blocker, volatile anesthetics, opioids
History of malignant hyperthermia
Patients taking CNS stimulants

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
Administering desflurane according to the patient's BIS valueAdministering desflurane according to the patient's BIS value	Drug	Administering desflurane according to the patient's BIS value
Administering desflurane at 1 MACAdministering desflurane at 1 MAC	Drug	Administering desflurane at 1 MAC

Primary outcome

The difference of 'wobble' value of the patients' BIS value between the two groups
Time frame: Every second from 10 minutes after skin incision to 10 minutes before surgery end.
'Wobble' is a variable that can measure the performance measurement of a pharmacokinetic model, or the reaction of the patient to a drug. We can calculate the performance error from the target of the therapy and the actual measured value, and derive the wobble by a specific formulas, which are described below. PE=(BISmeasured-BIStargeted)x100/BIStargeted MDPEi = median{PEij, j=1,…,Ni} MDAPEi = median{|PEij|, j=1,…,Ni} Wobblei = median{|PEij-MDPEi|, j=1,…,Ni} Divergence = slope{|PEij|, j=1,…,Ni}

1 secondary outcome

The difference of 'wobble' value of the patients' systolic arterial blood pressure value between the two groups
Time frame: Every 2.5 minutes from 10 minutes after skin incision to 10 minutes before surgery end

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
Derived from this study: PubMed 33152029Yang SM, Jung YS, Jung CW, Kim WH, Yoon SB, Lee HC. Comparison of bispectral index-guided and fixed-gas concentration techniques in desflurane and remifentanil anesthesia: A randomized controlled trial. PLoS One. 2020 Nov 5;15(11):e0241828. doi: 10.1371/journal.pone.0241828. eCollection 2020.

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.

Chul-Woo Jung principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 12 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: finished, as of the sponsor's last update on 15 Jul 2015. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The difference of 'wobble' value of the patients' BIS value between the two groups (time frame: Every second from 10 minutes after skin incision to 10 minutes before surgery end.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283866, which also lists 1 linked publication.

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 15 Jul 2015.