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NCT Number: NCT07258628

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

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Key information

Conditions

Hypertension Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes

Other names: MgSO₄, Epsom Salt, Magnesium Sulphate 15% Solution

Fentanyl (IV)

Drug

Fentanyl 2 mcg/kg administered intravenously as a bolus

Other names: Fentanyl Citrate, Sublimaze, Talinat, Fentanyl Injection

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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