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

NCT05615025 | Completed Phase 3

• 1 other identifier: CHUB-ITF sevo-propofol
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, General; Neuromuscular Transmission Disorders

Outcome Measures

Primary Outcomes (3)

• Maximum force at the adductor pollicis

  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

  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

  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

Study Arms (2)

Sevoflurane arm

EXPERIMENTAL

In this arm, anesthesia will be maintained by sevoflurane.

Drug: Sevoflurane

Propofol arm

EXPERIMENTAL

In this arm, anesthesia will be maintained by propofol.

Drug: Propofol

Interventions

Sevoflurane DRUG

Anesthesia will be maintained by sevoflurane.

Sevoflurane arm

Propofol DRUG

Anesthesia will be maintained by propofol.

Propofol arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (16)

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  PMID: 6017421 BACKGROUND

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MeSH Terms

Conditions

Neuromuscular Junction Diseases

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologists

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: January 20, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 7, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)