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General Anesthesia With and Without Muscle Relaxation and Muscle Strength Recovery

Primary Purpose

Rocuronium, Muscle Weakness, General Anaesthesia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Rocuronium
General anesthesia for surgery
Sponsored by
Clinical Hospital Centre Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rocuronium focused on measuring Rocuronium, Muscle strength, Residual blockade

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UHCZagreb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group general anesthesia without rocuronium

Active comparator: general anesthesia with rocuronium

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Muscle strenght recovery after general anesthesia
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

Secondary Outcome Measures

Full Information

First Posted
February 17, 2021
Last Updated
March 6, 2022
Sponsor
Clinical Hospital Centre Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT04760912
Brief Title
General Anesthesia With and Without Muscle Relaxation and Muscle Strength Recovery
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Centre Zagreb

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rocuronium, Muscle Weakness, General Anaesthesia
Keywords
Rocuronium, Muscle strength, Residual blockade

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group general anesthesia without rocuronium
Arm Type
Experimental
Arm Description
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.
Arm Title
Active comparator: general anesthesia with rocuronium
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Rocuronium bromide
Intervention Description
Rocuronium used for neuromuscular blokade during anesthesia and anesthesia without rocuronium
Intervention Type
Procedure
Intervention Name(s)
General anesthesia for surgery
Other Intervention Name(s)
General anesthesia
Intervention Description
General anesthesia with standard anesthetic monitoring,
Primary Outcome Measure Information:
Title
Muscle strenght recovery after general anesthesia
Description
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
Time Frame
Perioperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
UHCZagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Citations:
PubMed Identifier
2410263
Citation
Bowman WC. The neuromuscular junction: recent developments. Eur J Anaesthesiol. 1985 Mar;2(1):59-93. No abstract available.
Results Reference
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PubMed Identifier
11942873
Citation
Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. doi: 10.1034/j.1399-6576.2002.460216.x.
Results Reference
background
PubMed Identifier
28573344
Citation
Fuchs-Buder T, Schmartz D. [Residual neuromuscular blockade]. Anaesthesist. 2017 Jun;66(6):465-476. doi: 10.1007/s00101-017-0325-1. Erratum In: Anaesthesist. 2017 Aug;66(8):578. German.
Results Reference
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General Anesthesia With and Without Muscle Relaxation and Muscle Strength Recovery

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