General Anesthesia With and Without Muscle Relaxation and Muscle Strength Recovery

Sponsor

Clinical Hospital Centre Zagreb (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04760912

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rocuronium Muscle Weakness General Anaesthesia	Drug: Rocuronium Procedure: General anesthesia for surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.	Drug: Rocuronium Rocuronium used for neuromuscular blokade during anesthesia and anesthesia without rocuronium Other Names: Rocuronium bromide Procedure: General anesthesia for surgery General anesthesia with standard anesthetic monitoring, Other Names: General anesthesia

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.

Drug: Rocuronium

Rocuronium used for neuromuscular blokade during anesthesia and anesthesia without rocuronium

Other Names:

Rocuronium bromide

Procedure: General anesthesia for surgery

General anesthesia with standard anesthetic monitoring,

Other Names:

General anesthesia

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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