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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
75
Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes
Fentanyl 2 mcg/kg administered intravenously as a bolus
Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation
Ankara, Turkey (Türkiye)
NOT_YET_RECRUITINGAnkara City Hospital
Ankara, Turkey (Türkiye)
RECRUITINGMean 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.
Time frame: 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.
Time frame: Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
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.
Time frame: Intraoperatively when TOF count reaches 2.
Perioperative Complications
Incidence of perioperative complications, including hypotension, hypertension, bradycardia, tachycardia, and arrhythmia, recorded during the first 15 minutes after endotracheal intubation.
Time frame: From immediately after endotracheal intubation up to 15 minutes post-intubation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.