Magnesium Versus High Dose Fentanyl in Endotracheal Intub... | NCT04544163

Studies
Magnesium Versus High Dose Fentanyl in Endotracheal Intubation

NCT04544163

Sponsor

National Cancer Institute, Egypt

Status

Completed

Last Update Posted

May 11, 2021Actual

Enrollment

160Actual

Phase

Not Applicable

Conditions

Stress Response

Interventions

Magnesium sulfate- Fentanyl
Fentanyl 4Mcg/kg
Fentanyl 2Mcg/kg
Lidocaine 1.5 mg/kg

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

May 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

Sep 5, 2020Actual

Primary Completion Date

May 2, 2021Actual

Completion Date

May 5, 2021Actual

First Submitted Date

Sep 3, 2020

First Submission Date that Met QC Criteria

Sep 3, 2020

First Posted Date

Sep 10, 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

May 8, 2021

Last Update Posted Date

May 11, 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 is designed to assess the efficacy of MgSO4 versus high dose fentanyl compared to conventional anesthesia in attenuating stress response to intubation

Detailed Description

to assess the effect of MgSO4 combined with fentanyl compared to high dose fentanyl in attenuating stress response in cancer patients undergoing surgeries under general anesthesia requiring endotracheal intubation

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

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesium sulphate- Fentanyl	Experimental	30 mg per kg MgSo4 infusion in 100 ml saline over 10 minutes	Drug: Magnesium sulfate- Fentanyl Drug: Fentanyl 2Mcg/kg
Fentanyl 4 mic	Experimental	4 mic per kg fentanyl i.v	Drug: Fentanyl 4Mcg/kg
Fentanyl	Active Comparator	2 mic per kg fentanyl i.v	Drug: Fentanyl 2Mcg/kg
Lidocaine- Fentanyl	Experimental	Lidocaine 1.5 mg/kg	Drug: Fentanyl 2Mcg/kg Drug: Lidocaine 1.5 mg/kg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium sulfate- Fentanyl	Drug	drug administration before intubation	Magnesium sulphate- Fentanyl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
heart rate values	changes in heart rate values after intubation	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
blood pressure	mean arterial blood pressure values	5 minutes
coughing during intubation	coughing during intubation	lntubation time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cancer patients undergoing surgery under general anesthesia requiring endotracheal intubation
ASA I II
18 to 60

Exclusion Criteria:

allergy to any of the used drugs
renal or hepatic impairment
hypertensive patients, patients with cardiovascular or cerebrovascular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

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
Nahla N Shehab, MD	Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walaa Y Elsabeeny		Cairo		11796	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

data will be available upon reasonable request through contacting the corresponding author

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015775	Fractures, Stress

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl
D008012	Lidocaine

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000083	Acetanilides

Browse Leaves

Not provided

Browse Branches

Not provided