General Anesthesia With and Without Muscle Relaxation and Muscle Strength Recovery

Not Applicable

• Conditions: Rocuronium; Muscle Weakness; General Anaesthesia
• Interventions: Procedure: General anesthesia for surgery; Drug: Rocuronium

• Registration Number: NCT04760912
• Lead Sponsor: Clinical Hospital Centre Zagreb

Brief Summary

Neuromuscular blocking agents are often used during general anesthesia. Also, general anesthesia may be performed without use of neuromuscular blocking agents.

Avoiding neuromuscular relaxation enables better muscle strength recovery.

Detailed Description

Rocuronium is well used neuromuscular blocking agent during general anesthesia. Although very often used, neuromuscular blocking agents may sometimes have consequence in form of residual neuromuscular block.

Tha aim of the study is to compare influence of rocuronium during general anesthesia on muscle strength recovery measured by hand grip dynamometer. Measuremwnt of hand grip strength is perforrmed before and after general anesthesia. This research should contribute to better choice of anesthesia technique and better quality of patient recovery, as studies so far have not been detaily carried out.

Hypothesis of the research is that anesthesia without use of neuromuscular blocking agents may enable better recovery of muscle strength in immediate postoperative period.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-08
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients ASA status I-III for surgery under general anesthesia
• signed informed consent for participating in research

Exclusion Criteria

• neuromuscular disease
• poorly controled chronic or acute cardiovascular, respiratory or autoimmune disease
• known allergic reaction to any medication used in this research
• pregnancy
• refusal to participate in this research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group general anesthesia without rocuronium	General anesthesia for surgery	30 patient ASA classification 1-2 for general anesthesia. Standard anesthesia monitoring. After induction with Propofol and Sufentanil ( doses adjusted according to weight and age) anesthesia was maintained with sevorane. Muscle strength measured on three occasions with Yamar dinamometar for hand grip strength, before induciran to anesthesia and immediate after Salingeru from anesthesia, then again measured in first 24 hours.
Active comparator: general anesthesia with rocuronium	General anesthesia for surgery	30 patient ASA classification 1-2 for general anesthesia. Standard anesthesia monitoring with train-of-four (TOF). After induction with Propofol and Sufentanil (doses adjusted according to weight and age) and rocuronium 0,6 mg per kg, anesthesia maintained with sevorane. Muscle strength neasured with Yamar dinamometar for hand grip strength before induction to anesthesia and immediate after awakening from anesthesia, then again measured in first 24 hours.
Active comparator: general anesthesia with rocuronium	Rocuronium	30 patient ASA classification 1-2 for general anesthesia. Standard anesthesia monitoring with train-of-four (TOF). After induction with Propofol and Sufentanil (doses adjusted according to weight and age) and rocuronium 0,6 mg per kg, anesthesia maintained with sevorane. Muscle strength neasured with Yamar dinamometar for hand grip strength before induction to anesthesia and immediate after awakening from anesthesia, then again measured in first 24 hours.

Primary Outcome Measures

Name	Time	Method
Muscle strenght recovery after general anesthesia	Perioperative	Change in muscle strength recovery measured with hand grip dynamometer after general anesthesia with or without rocuronium. Better understanding of mechanism how neuromuscular blockade influences quality if patient recovery due to muscle strength recovery

Trial Locations

Locations (1)

UHCZagreb; 🇭🇷 Zagreb, Croatia