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

NCT07258628 | Completed

• 1 other identifier: TABED 1-25-1089
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypertension; Tachycardia

Keywords

Hemodynamic response; Elderly patients / age 50 and older; Magnesium sulfate; Fentanyl; Endotracheal intubation; Tachycardia; Hypertension

Outcome Measures

Primary Outcomes (2)

• Mean Arterial Pressure (MAP) Changes

  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

  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 Outcomes (2)

• Train of Four (TOF) Recovery Time

  Intraoperatively when TOF count reaches 2.

• Perioperative Complications

  From immediately after endotracheal intubation up to 15 minutes post-intubation.

Study Arms (3)

Magnesium Sulfate Infusion Group (30 mg/kg)

EXPERIMENTAL

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

Drug: magnesium sulfate

Fentanyl Only Group (2 mcg/kg)

EXPERIMENTAL

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

Drug: Fentanyl (IV)

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

EXPERIMENTAL

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

Drug: magnesium sulfate; Drug: Fentanyl (IV)

Interventions

magnesium sulfate DRUG

Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes

Also known as: MgSO₄, Epsom Salt, Magnesium Sulphate 15% Solution

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

Fentanyl (IV) DRUG

Fentanyl 2 mcg/kg administered intravenously as a bolus

Also known as: Fentanyl Citrate, Sublimaze, Talinat, Fentanyl Injection

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (2)

Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• Misganaw A, Sitote M, Jemal S, Melese E, Hune M, Seyoum F, Sema A, Bimrew D. Comparison of intravenous magnesium sulphate and lidocaine for attenuation of cardiovascular response to laryngoscopy and endotracheal intubation in elective surgical patients at Zewditu Memorial Hospital Addis Ababa, Ethiopia. PLoS One. 2021 Jun 1;16(6):e0252465. doi: 10.1371/journal.pone.0252465. eCollection 2021.

  PMID: 34061894 BACKGROUND

• Aissaoui Y, Qamous Y, Serghini I, Zoubir M, Salim JL, Boughalem M. Magnesium sulphate: an adjuvant to tracheal intubation without muscle relaxation--a randomised study. Eur J Anaesthesiol. 2012 Aug;29(8):391-7. doi: 10.1097/EJA.0b013e328355cf35.

  PMID: 22717726 BACKGROUND

• James MF, Beer RE, Esser JD. Intravenous magnesium sulfate inhibits catecholamine release associated with tracheal intubation. Anesth Analg. 1989 Jun;68(6):772-6.

  PMID: 2735543 BACKGROUND

MeSH Terms

Conditions

Hypertension; Tachycardia

Interventions

Magnesium Sulfate; Solutions; Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Pharmaceutical Preparations; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: December 2, 2025
• Study Start: October 10, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)