The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

April 8, 2024 updated by: Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and isoflurane at equi-minimum alveolar concentration using 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 isoflurane at equi-minimum alveolar concentration using 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

  • China
    • Hebei
      • Cangzhou, Hebei, China, 061001
        • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

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

Description

Inclusion Criteria:

  • patients undergoing general anesthesia using volatile anesthetics and intubation
  • patients with american society of anesthesiologist physical status I, II
  • 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 supraglottic airway 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: Treatment
  • 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: Isoflurane
Anesthesia was maintained with isoflurane.
Drug: Isoflurane
Anesthesia was maintained with isoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
Other Names:
  • ISO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qCON index
Time Frame: the 10 min at steady-state anesthesia after endotracheal intubation
The hypnotic potency of volatile anesthetics was evaluated by qCON 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
qNOX index
Time Frame: the 10 min at steady-state anesthesia after endotracheal intubation
The analgesic potency of volatile anesthetics was evaluated by qNOX 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

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Investigators

  • Principal Investigator: Ruizhao Lv, M.D, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

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)

January 1, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018CZTCWM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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