NCT04544163

Completed

Magnesium Versus High Dose Fentanyl in Endotracheal Intubati...

National Cancer Institute, Egypt Source

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Other study identifiers

Sponsor study identifier

AP2007-50108

Study Type

interventional

Actual enrollment (reported)

160

Locations

1 country

Sites

1

Timeline

Study Start

September 5, 2020

Actual (reported)

Primary Completion

May 2, 2021

Actual (reported)

Study Completion

May 5, 2021

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 160 participants
Study completion date: May 5, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 3, 2020
Actual (reported)
Study Start
September 5, 2020
Actual (reported)
First Posted
September 10, 2020
Actual (reported)
Primary Completion
May 2, 2021
Actual (reported)
Study Completion
May 5, 2021
Actual (reported)

Last Updated: May 11, 2021
Status Verified: May 2021
Last Update Submitted: May 8, 2021

Conditions

Stress Response

Outcome Measures

Primary Outcomes (1)

heart rate values
changes in heart rate values after intubation
5 minutes

Secondary Outcomes (2)

blood pressure
5 minutes
coughing during intubation
lntubation time

Study Arms (4)

Magnesium sulphate- Fentanyl

EXPERIMENTAL

30 mg per kg MgSo4 infusion in 100 ml saline over 10 minutes

Drug: Magnesium sulfate- FentanylDrug: 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

Interventions

Magnesium sulfate- FentanylDrug

drug administration before intubation

Also known as: MgSo4

Magnesium sulphate- Fentanyl

Fentanyl 4Mcg/kgDrug

drug administration with induction of anesthesia

Also known as: high dose fentanyl

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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

Sponsors & Collaborators

National Cancer Institute, Egypt
Otherlead

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

MeSH Terms

Conditions

Fractures, Stress

Interventions

FentanylLidocaine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline Compounds

Study Officials

Walaa Y Elsabeeny, MD
Lecturer
PRINCIPAL INVESTIGATOR
Nahla N Shehab, MD
Lecturer
PRINCIPAL INVESTIGATOR

Enrollment

160 participants (actual enrollment reported by the registry).

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

September 3, 2020

First Posted

September 10, 2020

Study Start

September 5, 2020

Actual (reported)

NCT07470229

Transcutaneous Vagus Nerve Stimulation (tVNS) and Stress Regulation During Performance Tasks

Not ApplicableNot Yet Recruiting

NCT07533643

Preoperative Topical Lidocaine Versus Intravenous Fentanyl to Obtund the Stress of Intubation Under Anesthesia.

Not ApplicableCompleted

NCT05502211

A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease

Not ApplicableUnknown

NCT07248202

Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia in Patients With Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass

Not ApplicableCompleted

NCT03806374

Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?

Not ApplicableCompleted

NCT04138472

Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Not ApplicableUnknown

Drug: Fentanyl 2Mcg/kg

Lidocaine- Fentanyl

EXPERIMENTAL

Lidocaine 1.5 mg/kg

Drug: Fentanyl 2Mcg/kgDrug: Lidocaine 1.5 mg/kg

Fentanyl 4 mic

Fentanyl 2Mcg/kgDrug

drug administration with induction of anesthesia

Also known as: Conventional anesthesia

FentanylLidocaine- FentanylMagnesium sulphate- Fentanyl

Lidocaine 1.5 mg/kgDrug

drug administaration 90 sec before intubation

Also known as: Lidocaine

Lidocaine- Fentanyl

to 60

You may not qualify if:

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

Contact the study team to confirm eligibility.

Amines

Primary Completion

May 2, 2021

Actual (reported)

Study Completion

May 5, 2021

Actual (reported)

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing: Will share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04544163
Data provider: ClinicalTrials.gov
Source updated: 2021-05-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:30 UTC

Locations

EG(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Magnesium sulphate- Fentanyl

Fentanyl 4 mic

Fentanyl

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Lidocaine- Fentanyl

You may not qualify if:

Data Sharing

Source record

Locations