Hemodynamics for Equi-MAC Anesthesia

October 18, 2019 updated by: Kyoung-Ho Ryu, MD, Kangbuk Samsung Hospital

Comparison of Vasodilative Effects Between Sevoflurane and Desflurane Using Peripheral Perfusion Index

The aim of this study is to compare the peripheral perfusion index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ether derivative anesthetics, including sevoflurane and desflurane, have direct activity on vascular tissue and both are vasodilators. However, there has been no direct comparison of vasodilative effect between sevoflurane and desflurane in vivo in humans. Peripheral perfusion index derived from photoplethysmographic waveform reflects peripheral vasomotor tone. Therefore, the purpose of this study is to compare the peripheral perfusion index values produced by sevoflurane and desflurane at equipotent concentration in patients undergoing single-agent inhalation anesthesia.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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 aged between 19 and 65 yr
  • patients with American Society of Anesthesiologists physical status classification I or II
  • patients scheduled for elective arthroscopic knee surgery under general anesthesia
  • patients obtaining written informed consent

Exclusion Criteria:

  • patients with a history of any disease associated with the autonomic nervous system
  • patients receiving any medication affecting the sympathetic or parasympathetic nervous systems
  • patients with cardiac arrhythmia, diabetes mellitus, and alcohol or drug abuse
  • 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sevoflurane
Anesthesia is maintained with sevoflurane.
Drug: Sevoflurane
End-tidal concentration of sevoflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
Other Names:
  • Sevorane
EXPERIMENTAL: Desflurane
Anesthesia is maintained with desflurane.
Drug: Desflurane
End-tidal concentration of desflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
Other Names:
  • Suprane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peripheral perfusion index
Time Frame: After a 30-min waiting period from the induction of anesthesia
peripheral perfusion index value at a steady-state anesthesia of age-corrected 1.0 MAC
After a 30-min waiting period from the induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean arterial pressure
Time Frame: After a 30-min waiting period from the induction of anesthesia
mean arterial pressure at a steady-state anesthesia of age-corrected 1.0 MAC
After a 30-min waiting period from the induction of anesthesia
heart rate
Time Frame: After a 30-min waiting period from the induction of anesthesia
heart rate at a steady-state anesthesia of age-corrected 1.0 MAC
After a 30-min waiting period from the induction of anesthesia

Collaborators and Investigators

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

Sponsor

Kangbuk Samsung Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 18, 2018

Primary Completion (ACTUAL)

November 13, 2018

Study Completion (ACTUAL)

November 13, 2018

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 18, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-05-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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