Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation

July 7, 2023 updated by: Denis SCHMARTZ, Brugmann University Hospital

Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation, in Humans: A Pilot Study

Many drugs have an influence on neuromuscular transmission. In clinical practice, neuromuscular blocking agents are commonly used, but even in the absence of neuromuscular blocking agents, anesthetic drugs can influence neuromuscular transmission. Especially volatile anesthetic agents have a clinical impact on neuromuscular transmission, they have been shown to prolong and deepen the effect of neuromuscular blocking agents. But even in the absence of neuromuscular blocking agents, volatile anesthetics can impair neuromuscular transmission. One mechanism of action is the desensitization of the acetylcholine receptors by shifting them from a normal to a desensitized state. This effect can weaken neuromuscular transmission by reducing the margin of safety that normally exists at the neuromuscular junction, or can cause an apparent increase in the capacity of neuromuscular blocking agents to block transmission.

In this study, the influence of sevoflurane and propofol on the maximum force, maximum speed of contraction and relaxation will be measured at the adductor pollicis in patients having general anesthesia without the use of neuromuscular blocking agents. Maximum force and speed of contraction and relaxation will be measured before and after anesthesia by either sevoflurane or propofol. Primary outcome is the influence of either anesthetic agent on maximum muscular force and speed of contraction - relaxation, and if this influence is greater for volatile anesthetic agents than for intravenous anesthetic agents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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 Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Patients (male or female) from 18 - 80 years
  • Scheduled for surgery without the use of neuromuscular blocking agents
  • Health care insurance in Belgium
  • Written informed consent

Exclusion Criteria:

  • Any pathology involving neuromuscular transmission
  • Confirmed neuropathy of any origin
  • Expected anesthesia duration < 30 min
  • Renal insufficiency defined as a glomerular filtration rate < 40 mL/min/m2
  • Hepatic insufficiency defined as an increase > 1.5 * normal value of hepatic enzymes
  • Confirmed or suspected pregnancy
  • Language barrier
  • Any patient which will receive unplanned neuromuscular blocking agents during surgery
  • Any history of personal or familial suspected malignant hyperthermia

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane arm
In this arm, anesthesia will be maintained by sevoflurane.
Drug: Sevoflurane
Anesthesia will be maintained by sevoflurane.
Experimental: Propofol arm
In this arm, anesthesia will be maintained by propofol.
Drug: Propofol
Anesthesia will be maintained by propofol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum force at the adductor pollicis
Time Frame: 3 hours
Maximum force developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum force developped before and after anesthesia will be compared. The difference in force (Newton) will be measured.
3 hours
Maximum speed of contraction at the adductor pollicis
Time Frame: 3 hours
Maximum speed of contraction developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum speed of contraction developped before and after anesthesia will be compared. The difference in force (Newton/seconds) will be measured.
3 hours
Maximum speed of relaxation at the adductor pollicis
Time Frame: 3 hours
Maximum speed of relaxation developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum speed of relaxation developped before and after anesthesia will be compared. The difference in force (Newton/seconds) will be measured.
3 hours

Collaborators and Investigators

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

Sponsor

Brugmann University 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)

January 20, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 7, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-ITF sevo-propofol

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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