The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

May 7, 2018 updated by: Kyoungho Ryu, Kangbuk Samsung Hospital

The Ratio of Hypnotic to Analgesic Potency of Sevoflurane and Desflurane : Randomized Controlled Trial

The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anesthetic agents vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there is no study that demonstrate the difference between analgesic potency of volatile anesthetics. The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and desflurane at equi-minimum alveolar concentration using SPI and EEG analysis.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing general anesthesia using volatile anesthetics and supraglottic airway (I-gel™)
  • patients with american society of anesthesiologist physical status I, II
  • patients aged 19-65 years
  • patients obtaining written informed consent

Exclusion Criteria:

  • patients with a history of any psychiatric or neurological disease
  • patients who had received any medication affecting the central nervous system
  • patients who had received medication affecting the sympathetic or parasympathetic nervous systems
  • patients undergoing tracheal intubation for airway management
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane
Anesthesia was maintained with sevoflurane.
Drug: Sevoflurane
Anesthesia was maintained with sevoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
Other Names:
  • SEVO
Experimental: Desflurane
Anesthesia was maintained with desflurane.
Drug: Desflurane
Anesthesia was maintained with desflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
Other Names:
  • DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical pleth index
Time Frame: the 10 min at steady-state anesthesia after endotracheal intubation
The analgesic potency of volatile anesthetics was evaluated by surgical pleth index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation).
the 10 min at steady-state anesthesia after endotracheal intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bispectral index
Time Frame: the 10 min at steady-state anesthesia after endotracheal intubation
The hypnotic potency of volatile anesthetics was evaluated by bispectral index during standardized nociceptive stimulus (30 s, 50 mA, 50 Hz tetanic stimulation).
the 10 min at steady-state anesthesia after endotracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Investigators

  • Principal Investigator: Kyoungho Ryu, M.D., Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2016

Primary Completion (Actual)

July 13, 2016

Study Completion (Actual)

July 13, 2016

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-12-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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