General Anesthesia With and Without Muscle Relaxation and Muscle Strength Recovery

March 6, 2022 updated by: Martina Miklic Bublic, MD, PhD, Clinical Hospital Centre Zagreb

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • UHCZagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Procedure: General anesthesia for surgery
General anesthesia with standard anesthetic monitoring,
Other Names:
  • General anesthesia
ACTIVE_COMPARATOR: 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.
Procedure: General anesthesia for surgery
General anesthesia with standard anesthetic monitoring,
Other Names:
  • General anesthesia
Drug: Rocuronium
Rocuronium used for neuromuscular blokade during anesthesia and anesthesia without rocuronium
Other Names:
  • Rocuronium bromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Centre Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (ACTUAL)

February 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022 (ITCC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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