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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615025
• Other study ID #: CHUB-ITF sevo-propofol
• Status: Completed
• Phase: Phase 3
• Start date: January 20, 2023
• Est. completion date: July 7, 2023

Study information

• Verified date: July 2023
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 7, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Drug:
• Sevoflurane
Anesthesia will be maintained by sevoflurane.
• Propofol
Anesthesia will be maintained by propofol.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (16)

Baurain MJ, Hoton F, D'Hollander AA, Cantraine FR. Is recovery of neuromuscular transmission complete after the use of neostigmine to antagonize block produced by rocuronium, vecuronium, atracurium and pancuronium? Br J Anaesth. 1996 Oct;77(4):496-9. doi: 10.1093/bja/77.4.496. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Feldman S, Karalliedde L. Drug interactions with neuromuscular blockers. Drug Saf. 1996 Oct;15(4):261-73. doi: 10.2165/00002018-199615040-00004. — View Citation

Gage PW. Ion channels and postsynaptic potentials. Biophys Chem. 1988 Feb;29(1-2):95-101. doi: 10.1016/0301-4622(88)87028-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pereda AE, Faber DS. Activity-dependent short-term enhancement of intercellular coupling. J Neurosci. 1996 Feb 1;16(3):983-92. doi: 10.1523/JNEUROSCI.16-03-00983.1996. — View Citation

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. — View Citation

Silverman DG, Brull SJ. The effect of a tetanic stimulus on the response to subsequent tetanic stimulation. Anesth Analg. 1993 Jun;76(6):1284-7. doi: 10.1213/00000539-199376060-00017. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yamaoka K, Vogel SM, Seyama I. Na+ channel pharmacology and molecular mechanisms of gating. Curr Pharm Des. 2006;12(4):429-42. doi: 10.2174/138161206775474468. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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