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Completed

NCT Number: NCT02283866

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

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.

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Key information

Conditions

Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administering desflurane according to the patient's BIS value

Drug

Administering desflurane according to the patient's BIS value

Administering desflurane at 1 MAC

Drug

Administering desflurane at 1 MAC

Primary outcomes

  1. 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}

Secondary outcomes

  1. 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

    Described above

Other outcomes

  1. Eye opening time to prodding after stopping of anesthetics.

    Time frame: 1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2014
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.