NCT04760912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

February 17, 2021

Last Update Submit

January 17, 2026

Conditions

RocuroniumMuscle WeaknessGeneral Anaesthesia

Keywords

RocuroniumMuscle strengthResidual blockade

Outcome Measures

Primary Outcomes (1)

  • 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

    Perioperative

Study Arms (2)

Experimental group general anesthesia without rocuronium

EXPERIMENTAL

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

Active comparator: general anesthesia with rocuronium

ACTIVE COMPARATOR

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: RocuroniumProcedure: General anesthesia for surgery

Interventions

RocuroniumDRUG

Rocuronium used for neuromuscular blokade during anesthesia and anesthesia without rocuronium

Also known as: Rocuronium bromide
Active comparator: general anesthesia with rocuronium
General anesthesia for surgeryPROCEDURE

General anesthesia with standard anesthetic monitoring,

Also known as: General anesthesia
Active comparator: general anesthesia with rocuroniumExperimental group general anesthesia without rocuronium

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHCZagreb

Zagreb, 10000, Croatia

Location

Related Publications (3)

  • Bowman WC. The neuromuscular junction: recent developments. Eur J Anaesthesiol. 1985 Mar;2(1):59-93. No abstract available.

    PMID: 2410263BACKGROUND

  • 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.

    PMID: 11942873BACKGROUND

  • Fuchs-Buder T, Schmartz D. [Residual neuromuscular blockade]. Anaesthesist. 2017 Jun;66(6):465-476. doi: 10.1007/s00101-017-0325-1. German.

    PMID: 28573344BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Interventions

RocuroniumAnesthesia, GeneralSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 18, 2021

Study Start

April 1, 2020

Primary Completion

August 20, 2022

Study Completion

September 20, 2022

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

CR(1)