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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate Infusion Group (30 mg/kg) | Experimental | Arm M: Magnesium sulfate (30 mg/kg IV over 10 min) |
|
| Fentanyl Only Group (2 mcg/kg) | Experimental | Participants will receive fentanyl 2 mcg/kg intravenously as a bolus |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium sulfate | Drug | Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Train of Four (TOF) Recovery Time | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation | Ankara | Ankara | 06800 | Turkey (Türkiye) | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34061894 | Background | 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. | |
| 22717726 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D012996 | Solutions |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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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.
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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.
|
| Fentanyl (IV) | Drug | Fentanyl 2 mcg/kg administered intravenously as a bolus |
|
|
| Perioperative Complications |
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. |
| Ankara City Hospital |
| Ankara |
| 06800 |
| Turkey (Türkiye) |
| 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. |
| 2735543 | 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. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D004364 | Pharmaceutical Preparations |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |