Comparison of Fentanyl and Magnesium to Control Reflex Hemodynamics in Patients Aged 50 and Older

March 18, 2026 updated by: Ankara City Hospital Bilkent

Magnesium and Fentanyl in Preventing Reflex Hemodynamic Response to Endotracheal Intubation in Patients Aged 50 Years and Older

This prospective, randomized, controlled trial aims to evaluate the effects of magnesium sulfate and fentanyl on the hemodynamic response to endotracheal intubation in surgical patients aged 50 years and older. A total of 75 patients will be enrolled and randomized into three groups: magnesium sulfate alone, magnesium sulfate plus fentanyl, and fentanyl alone. The primary outcome measures are changes in mean arterial pressure (MAP) and heart rate before and after intubation. Secondary outcomes include BIS, SEF, ST, TOF recovery times, intraoperative hemodynamic stability, and perioperative complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endotracheal intubation can trigger significant hemodynamic changes, such as tachycardia and hypertension, due to sympathetic activation. These responses are particularly detrimental in older patients with cardiovascular comorbidities, increasing the risk of perioperative morbidity and mortality.

The aim of this study is to compare the effectiveness of magnesium sulfate and fentanyl, administered alone or in combination, in attenuating the hemodynamic response to intubation in patients aged 50 years and older undergoing elective surgery.

This is a single-center, prospective, randomized, controlled trial. A total of 75 patients will be randomized into three groups:

Group M: Magnesium sulfate 30 mg/kg IV infusion over 10 minutes Group X: Magnesium sulfate 30 mg/kg IV infusion over 10 minutes plus fentanyl 2 mcg/kg IV Group F: Fentanyl 2 mcg/kg IV Standardized anesthesia induction and monitoring will be performed. The primary outcome measures are mean arterial pressure (MAP) and heart rate, recorded at baseline, post-induction, and at 1, 3, 5, 10, and 15 minutes after intubation. Secondary outcomes include BIS, SEF, and ST values; TOF recovery times; anesthesia duration; intraoperative blood loss; fluids and blood products administered; and perioperative complications.

The findings of this study are expected to provide valuable insights into the pharmacological management of intubation-induced hemodynamic responses in the elderly surgical population.

Study Type

Interventional

Enrollment (Actual)

76

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

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara City Hospital
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 50 years
  • Patients scheduled for elective surgery under general anesthesia
  • Patients requiring endotracheal intubation with a single-lumen tube
  • Provision of written informed consent

Exclusion Criteria:

  • Known renal or hepatic insufficiency
  • Thyroid dysfunction
  • Uncontrolled hypertension
  • Suspected difficult airway (Mallampati ≥ 3 or history of difficult intubation)
  • Known allergy or hypersensitivity to study medications
  • Myocardial infarction within the past 3 months
  • Presence of heart block
  • Preoperative hypermagnesemia

Withdrawal Criteria:

  • Laryngoscopy time exceeding 20 seconds
  • Withdrawal of informed consent
  • Patient withdrawal from the study at any time

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium Sulfate Infusion Group (30 mg/kg)
Arm M: Magnesium sulfate (30 mg/kg IV over 10 min)
Drug: magnesium sulfate
Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes
Other Names:
  • Epsom Salt
  • MgSO₄
  • Magnesium Sulphate 15% Solution
Experimental: Fentanyl Only Group (2 mcg/kg)
Participants will receive fentanyl 2 mcg/kg intravenously as a bolus
Drug: Fentanyl (IV)
Fentanyl 2 mcg/kg administered intravenously as a bolus
Other Names:
  • Fentanyl Citrate
  • Sublimaze
  • Talinat
  • Fentanyl Injection
Experimental: Combined Magnesium Sulfate (30 mg/kg) and Fentanyl (2 mcg/kg) Group
Participants will receive magnesium sulfate 30 mg/kg intravenously over 10 minutes combined with fentanyl 2 mcg/kg intravenously
Drug: magnesium sulfate
Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes
Other Names:
  • Epsom Salt
  • MgSO₄
  • Magnesium Sulphate 15% Solution
Drug: Fentanyl (IV)
Fentanyl 2 mcg/kg administered intravenously as a bolus
Other Names:
  • Fentanyl Citrate
  • Sublimaze
  • Talinat
  • Fentanyl Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure (MAP) Changes
Time Frame: Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
Change in mean arterial pressure (MAP) to assess the hemodynamic response to endotracheal intubation. MAP will be measured at baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
1. Heart Rate (HR) Changes
Time Frame: Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
Change in heart rate to assess the hemodynamic response to endotracheal intubation. Heart rate will be measured at baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Train of Four (TOF) Recovery Time
Time Frame: Intraoperatively when TOF count reaches 2.
Time required for early neuromuscular recovery following administration of rocuronium. Continuous neuromuscular monitoring will be performed, and the duration from rocuronium injection until return of TOF count to 2 will be recorded.
Intraoperatively when TOF count reaches 2.
Perioperative Complications
Time Frame: From immediately after endotracheal intubation up to 15 minutes post-intubation.
Incidence of perioperative complications, including hypotension, hypertension, bradycardia, tachycardia, and arrhythmia, recorded during the first 15 minutes after endotracheal intubation.
From immediately after endotracheal intubation up to 15 minutes post-intubation.

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 10, 2025

Primary Completion (Actual)

January 10, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 1-25-1089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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