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

NCT ID: NCT05615025

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2023-07-07

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, General Neuromuscular Transmission Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sevoflurane arm

In this arm, anesthesia will be maintained by sevoflurane.

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Anesthesia will be maintained by sevoflurane.

Propofol arm

In this arm, anesthesia will be maintained by propofol.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Anesthesia will be maintained by propofol.

Interventions

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Sevoflurane

Anesthesia will be maintained by sevoflurane.

Intervention Type DRUG

Propofol

Anesthesia will be maintained by propofol.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Denis SCHMARTZ

Anesthesiologists

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Reference Type BACKGROUND
PMID: 8942335 (View on PubMed)

Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a.

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Debaene B, Frasca D, Moreillon F, D'Hollander AA. 100 Hz-5 s tetanic stimulation to illustrate the presence of "residual paralysis" co-existing with accelerometric 0.90 train-of-four ratio-A proof-of-concept study. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100903. doi: 10.1016/j.accpm.2021.100903. Epub 2021 Jun 17.

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Dubois PE, Mitchell J, Regnier M, Passeraub PA, Moreillon F, d'Hollander AA. The interest of 100 versus 200 Hz tetanic stimulations to quantify low levels of residual neuromuscular blockade with mechanomyography: a pilot study. J Clin Monit Comput. 2022 Aug;36(4):1131-1137. doi: 10.1007/s10877-021-00745-6. Epub 2021 Jul 24.

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Reference Type BACKGROUND
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Karis JH, Gissen AJ, Nastuk WL. The effect of volatile anesthetic agents on neuromuscular transmission. Anesthesiology. 1967 Jan-Feb;28(1):128-34. doi: 10.1097/00000542-196701000-00014. No abstract available.

Reference Type BACKGROUND
PMID: 6017421 (View on PubMed)

Ochiai R, Guthrie RD, Motoyama EK. Effects of varying concentrations of halothane on the activity of the genioglossus, intercostals, and diaphragm in cats: an electromyographic study. Anesthesiology. 1989 May;70(5):812-6. doi: 10.1097/00000542-198905000-00018.

Reference Type BACKGROUND
PMID: 2719316 (View on PubMed)

Ochiai R, Guthrie RD, Motoyama EK. Differential sensitivity to halothane anesthesia of the genioglossus, intercostals, and diaphragm in kittens. Anesth Analg. 1992 Mar;74(3):338-44. doi: 10.1213/00000539-199203000-00004.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 8558267 (View on PubMed)

Raines DE. Anesthetic and nonanesthetic halogenated volatile compounds have dissimilar activities on nicotinic acetylcholine receptor desensitization kinetics. Anesthesiology. 1996 Mar;84(3):663-71. doi: 10.1097/00000542-199603000-00022.

Reference Type BACKGROUND
PMID: 8659795 (View on PubMed)

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Reference Type BACKGROUND
PMID: 8098919 (View on PubMed)

Simons JC, Pierce E, Diaz-Gil D, Malviya SA, Meyer MJ, Timm FP, Stokholm JB, Rosow CE, Kacmarek RM, Eikermann M. Effects of Depth of Propofol and Sevoflurane Anesthesia on Upper Airway Collapsibility, Respiratory Genioglossus Activation, and Breathing in Healthy Volunteers. Anesthesiology. 2016 Sep;125(3):525-34. doi: 10.1097/ALN.0000000000001225.

Reference Type BACKGROUND
PMID: 27404221 (View on PubMed)

Stauble CG, Stauble RB, Schaller SJ, Unterbuchner C, Fink H, Blobner M. Effects of single-shot and steady-state propofol anaesthesia on rocuronium dose-response relationship: a randomised trial. Acta Anaesthesiol Scand. 2015 Aug;59(7):902-11. doi: 10.1111/aas.12523. Epub 2015 May 12.

Reference Type BACKGROUND
PMID: 25962311 (View on PubMed)

Tassonyi E, Charpantier E, Muller D, Dumont L, Bertrand D. The role of nicotinic acetylcholine receptors in the mechanisms of anesthesia. Brain Res Bull. 2002 Jan 15;57(2):133-50. doi: 10.1016/s0361-9230(01)00740-7.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 16472137 (View on PubMed)

Other Identifiers

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CHUB-ITF sevo-propofol

Identifier Type: -

Identifier Source: org_study_id

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