Does Adding Magnesium Sulphate to Low Dose Rocuronium Aff... | NCT04510337

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

NCT04510337

Sponsor

National Cancer Institute, Egypt

Status

Completed

Last Update Posted

Mar 5, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

standard rocuronium dose
Magnesium sulfate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2018Actual

Primary Completion Date

Feb 20, 2021Actual

Completion Date

Feb 20, 2021Actual

First Submitted Date

Aug 10, 2020

First Submission Date that Met QC Criteria

Aug 11, 2020

First Posted Date

Aug 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2021

Last Update Posted Date

Mar 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walaa Youssef Elsabeeny, Lecturer of anesthesia and pain management, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
standard rocuronium dose	Drug	0.6 mg/kg rocuronium during induction of anesthesia	Standard rocuronium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Onset and duration of muscle relaxant	Onset time of muscle relaxant and duration	90 minutes

Secondary Outcomes

Measure	Description	Time Frame
Degree of muscle relaxation	depth of blockade	90 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Laryngeal tumors

ASA I-II

Age 30-70 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walaa Y Elsabeeny, MD	Lecturer	Principal Investigator
Mohamed A Wadod, MD	Lecturer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute		Cairo		11796	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D000077123	Rocuronium
D008278	Magnesium Sulfate

Ancestor Terms

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided