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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-01-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypertension Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, three-arm, randomized, parallel-group interventional trial. Participants are assigned in a 1:1:1 ratio via sealed opaque envelopes to receive MgSO₄ 30 mg/kg IV over 10 minutes, MgSO₄ 30 mg/kg IV over 10 minutes plus fentanyl 2 mcg/kg IV, or fentanyl 2 mcg/kg IV. Masking: single-blind (outcome assessor/statistician); treating anesthesiologist is open-label. Standardized induction is performed with BIS and TOF monitoring; cases with laryngoscopy time \>20 seconds are excluded. Primary endpoints are MAP and heart rate changes at baseline, post-intubation, and at 1-15 minutes after intubation.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

In this trial, the anesthesiologist administering the study drugs is not blinded to group allocation. However, statistical analyses will be performed by an independent researcher who is blinded to treatment assignment. Therefore, the outcomes assessor is blinded.

Study Groups

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Magnesium Sulfate Infusion Group (30 mg/kg)

Arm M: Magnesium sulfate (30 mg/kg IV over 10 min)

Group Type EXPERIMENTAL

magnesium sulfate

Intervention Type DRUG

Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes

Fentanyl Only Group (2 mcg/kg)

Participants will receive fentanyl 2 mcg/kg intravenously as a bolus

Group Type EXPERIMENTAL

Fentanyl (IV)

Intervention Type DRUG

Fentanyl 2 mcg/kg administered intravenously as a bolus

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

Group Type EXPERIMENTAL

magnesium sulfate

Intervention Type DRUG

Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes

Fentanyl (IV)

Intervention Type DRUG

Fentanyl 2 mcg/kg administered intravenously as a bolus

Interventions

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magnesium sulfate

Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes

Intervention Type DRUG

Fentanyl (IV)

Fentanyl 2 mcg/kg administered intravenously as a bolus

Intervention Type DRUG

Other Intervention Names

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MgSO₄ Epsom Salt Magnesium Sulphate 15% Solution Fentanyl Citrate Sublimaze Talinat Fentanyl Injection

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No