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

Ankara City Hospital

Status: Enrolling

Conditions: Hypertension; Tachycardia

Treatments: Drug: magnesium sulfate; Drug: Fentanyl (IV)

Study type: Interventional

Funder types: Other

Identifiers

NCT07258628

TABED 1-25-1089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Magnesium Sulfate Infusion Group (30 mg/kg)

Experimental group

Description:

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

Treatment:

Drug: magnesium sulfate

Fentanyl Only Group (2 mcg/kg)

Experimental group

Description:

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

Treatment:

Drug: Fentanyl (IV)

Combined Magnesium Sulfate (30 mg/kg) and Fentanyl (2 mcg/kg) Group

Experimental group

Description:

Participants will receive magnesium sulfate 30 mg/kg intravenously over 10 minutes combined with fentanyl 2 mcg/kg intravenously

Treatment:

Drug: Fentanyl (IV)

Drug: magnesium sulfate