Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02283866
Enrollment
48
Registered
2014-11-05
Start date
2014-06-30
Completion date
2015-03-31
Last updated
2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia

Brief summary

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.

Interventions

DRUGAdministering desflurane according to the patient's BIS value

Administering desflurane according to the patient's BIS value

DRUGAdministering desflurane at 1 MAC

Administering desflurane at 1 MAC

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for operation under balanced anesthesia using desflurane and remifentanil

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
The difference of 'wobble' value of the patients' BIS value between the two groupsEvery 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}

Secondary

MeasureTime frameDescription
The difference of 'wobble' value of the patients' systolic arterial blood pressure value between the two groupsEvery 2.5 minutes from 10 minutes after skin incision to 10 minutes before surgery endDescribed above

Other

MeasureTime frame
Eye opening time to prodding after stopping of anesthetics.1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026