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

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ClinicalTrials.gov Identifier: NCT02283866
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia Drug: Administering desflurane according to the patient's BIS value Drug: Administering desflurane at 1 MAC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Arm Intervention/treatment
Experimental: Administering desflurane according to the patient's BIS value
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.
Drug: Administering desflurane according to the patient's BIS value
Administering desflurane according to the patient's BIS value

Experimental: Administering desflurane at 1 MAC
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.
Drug: Administering desflurane at 1 MAC
Administering desflurane at 1 MAC




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283866


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chul-Woo Jung Seoul National University Hospital

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Responsible Party: Chul-Woo Jung, associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02283866     History of Changes
Other Study ID Numbers: CWJung_BA
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Anesthetics
Desflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General