AnesthesiaNCT04510337

Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects Depth of Blockade

A study testing standard rocuronium dose and Magnesium sulfate in people with Anesthesia, run by National Cancer Institute, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 30 to 70 years
Conditions the study is for: Anesthesia
What is being tested?: standard rocuronium dose and Magnesium sulfate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 2 Apr 2018to 20 Feb 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

National Cancer Institute
Cairo, 11796

Other trials in Egypt

About this study

Official title: Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects the Depth of Blockade in Cancer Patients Undergoing Direct Laryngoscope Surgical Procedures

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

Read the detailed description

Comparing the effect of magnesium sulphate combined to low dose rocuronium versus standard dose rocuronium in cancer patients undergoing direct laryngoscopy for laryngeal tumors regarding intubating conditions, intraoperative relaxation, depth of anesthesia and recovery time.

Conditions: Anesthesia
Being tested: standard rocuronium dose, Magnesium sulfate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

standard rocuronium doseDrug
Also called standard dose rocuronium
0.6 mg/kg rocuronium during induction of anesthesia
Magnesium sulfateDrug
Also called low dose rocuronium
50 mg/kg magnesium sulphate added to 0.40 mg/kg rocuronium

Study groups in NCT04510337
Study group	Role	What they receive
Standard rocuronium	Active comparator	patients received rocuronium 0.6mg/kg Receives: Drug: standard rocuronium dose
Magnesium	Experimental	patients received 100 ml saline with 50mg/kg magnesium sulphate infusion over 10 minutes Receives: Drug: Magnesium sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

Onset and duration of muscle relaxant
Onset time of muscle relaxant and duration
Measured: 90 minutes

Secondary outcomes (1)

Degree of muscle relaxation
depth of blockade
Measured: 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 201820 Feb 2021

First posted12 Aug 2020
Study start2 Apr 2018
Primary completion20 Feb 2021
Study completion20 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnesthesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04510337
Sponsor's protocol ID: 201617031.2P
Status last verified: Mar 2021
First submitted: 10 Aug 2020
Last updated: 5 Mar 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Adding Magnesium Sulphate to Low Dose Rocuronium Affects the Depth of Blockade in Cancer Patients Undergoing Direct Laryngoscope Surgical Procedures
ClinicalTrials.gov ID: NCT04510337
Acronym / sponsor ID: 201617031.2P
Conditions: Anesthesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: National Cancer Institute, EgyptUniversity, hospital or other
Study start: 2 Apr 2018 (actual)
Primary completion: 20 Feb 2021 (actual)
Study completion: 20 Feb 2021 (actual)
First posted: 12 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard rocuronium	Active comparator	Drug: standard rocuronium dosepatients received rocuronium 0.6mg/kg
Magnesium	Experimental	Drug: Magnesium sulfatepatients received 100 ml saline with 50mg/kg magnesium sulphate infusion over 10 minutes

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
standard rocuronium doseAlso: standard dose rocuronium0.6 mg/kg rocuronium during induction of anesthesia	Drug	Standard rocuronium
Magnesium sulfateAlso: low dose rocuronium50 mg/kg magnesium sulphate added to 0.40 mg/kg rocuronium	Drug	Magnesium

Primary outcome

Onset and duration of muscle relaxant
Time frame: 90 minutes
Onset time of muscle relaxant and duration

1 secondary outcome

Degree of muscle relaxation
Time frame: 90 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.

Related trials for Anesthesia

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RecruitingObservational study
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Post-induction Hypotension (PIH), Gastrointestinal Tumor Surgery
Active, not recruiting
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Atrial Fibrillation (Paroxysmal)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Walaa Y Elsabeeny, MD principal investigator

Lecturer

Mohamed A Wadod, MD study director

Lecturer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing standard rocuronium dose and Magnesium sulfate in people with Anesthesia, run by National Cancer Institute, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset and duration of muscle relaxant (time frame: 90 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04510337.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.