NCT04510337

Brief Summary

This study aim is to compare the effect of magnesium sulphate combined with low dose rocuronium versus standard dose rocuronium

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 not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

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 2, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2.9 years

First QC Date

August 10, 2020

Last Update Submit

March 4, 2021

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Onset and duration of muscle relaxant

    Onset time of muscle relaxant and duration

    90 minutes

Secondary Outcomes (1)

  • Degree of muscle relaxation

    90 minutes

Study Arms (2)

Standard rocuronium

ACTIVE COMPARATOR

patients received rocuronium 0.6mg/kg

Drug: standard rocuronium dose

Magnesium

EXPERIMENTAL

patients received 100 ml saline with 50mg/kg magnesium sulphate infusion over 10 minutes

Drug: Magnesium sulfate

Interventions

standard rocuronium doseDRUG

0.6 mg/kg rocuronium during induction of anesthesia

Also known as: standard dose rocuronium
Standard rocuronium
Magnesium sulfateDRUG

50 mg/kg magnesium sulphate added to 0.40 mg/kg rocuronium

Also known as: low dose rocuronium
Magnesium

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Laryngeal tumors
  • ASA I-II
  • Age 30-70 years

You may not qualify if:

  • Renal and or hepatic insufficiency
  • Neuromuscular disease
  • Large glottic and/or supra-glottic lesions with or without breathing difficulties
  • Known allergy to any of the used drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Interventions

RocuroniumMagnesium Sulfate

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Walaa Y Elsabeeny, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

  • Mohamed A Wadod, MD

    Lecturer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and pain management

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 12, 2020

Study Start

April 2, 2018

Primary Completion

February 20, 2021

Study Completion

February 20, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

EG(1)