Magnesium Versus High Dose Fentanyl in Endotracheal Intubation

May 8, 2021 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Magnesium Versus High Dose Fentanyl in Attenuating Stress Response to Endotracheal Intubation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11796
        • Walaa Y Elsabeeny

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium sulphate- Fentanyl
30 mg per kg MgSo4 infusion in 100 ml saline over 10 minutes
Drug: Magnesium sulfate- Fentanyl
drug administration before intubation
Other Names:
  • MgSo4
Drug: Fentanyl 2Mcg/kg
drug administration with induction of anesthesia
Other Names:
  • Conventional anesthesia
Experimental: Fentanyl 4 mic
4 mic per kg fentanyl i.v
Drug: Fentanyl 4Mcg/kg
drug administration with induction of anesthesia
Other Names:
  • high dose fentanyl
Active Comparator: Fentanyl
2 mic per kg fentanyl i.v
Drug: Fentanyl 2Mcg/kg
drug administration with induction of anesthesia
Other Names:
  • Conventional anesthesia
Experimental: Lidocaine- Fentanyl
Lidocaine 1.5 mg/kg
Drug: Fentanyl 2Mcg/kg
drug administration with induction of anesthesia
Other Names:
  • Conventional anesthesia
Drug: Lidocaine 1.5 mg/kg
drug administaration 90 sec before intubation
Other Names:
  • Lidocaine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Principal Investigator: Nahla N Shehab, MD, lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2020

Primary Completion (Actual)

May 2, 2021

Study Completion (Actual)

May 5, 2021

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 8, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP2007-50108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Response

Clinical Trials on Magnesium sulfate- Fentanyl

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe