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Clinical Trials/NCT04760912
NCT04760912
Completed
Phase 4

Comparison of General Anesthesia With Use of Muscle Relaxation and General Anesthesia Without Muscle Relaxation on Recovery of Muscle Strength of the Patients

Clinical Hospital Centre Zagreb1 site in 1 country60 target enrollmentApril 1, 2020

Overview

Phase
Phase 4
Intervention
General anesthesia for surgery
Conditions
Rocuronium
Sponsor
Clinical Hospital Centre Zagreb
Enrollment
60
Locations
1
Primary Endpoint
Muscle strenght recovery after general anesthesia
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
September 20, 2022
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Clinical Hospital Centre Zagreb
Responsible Party
Principal Investigator
Principal Investigator

Martina Miklic Bublic, MD, PhD

Principal investigator

Clinical Hospital Centre Zagreb

Eligibility Criteria

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

Arms & Interventions

Experimental group general anesthesia without rocuronium

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.

Intervention: General anesthesia for surgery

Active comparator: general anesthesia with 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.

Intervention: Rocuronium

Active comparator: general anesthesia with 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.

Intervention: General anesthesia for surgery

Outcomes

Primary Outcomes

Muscle strenght recovery after general anesthesia

Time Frame: 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

Study Sites (1)

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