Comparison of Analgesic Effect of Volatile Anesthetics

May 13, 2018 updated by: Kyoungho Ryu, Kangbuk Samsung Hospital

The Comparison of Analgesic Effect of Volatile Anesthetics Using Surgical Pleth Index

The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different bispectral index values. However, the difference between analgesic effects of volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index-guided remifentanil infusion.

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 balanced general anesthesia using volatile anesthetics and remifentanil
  • 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
End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
Other Names:
  • SEVO
Experimental: Desflurane
Anesthesia was maintained with desflurane.
Drug: Desflurane
End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
Other Names:
  • DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remifentanil consumption (µg/kg/min)
Time Frame: During the intraoperative period
During the intraoperative period

Secondary Outcome Measures

Outcome Measure
Time Frame
Target effective site concentration of remifentanil (ng/ml)
Time Frame: After at least 10 min of stable surgical pleth index values
After at least 10 min of stable surgical pleth index values

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

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)

July 12, 2016

Primary Completion (Actual)

October 5, 2016

Study Completion (Actual)

October 8, 2016

Study Registration Dates

First Submitted

July 9, 2016

First Submitted That Met QC Criteria

July 9, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 13, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-05-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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