Hypertension, Tachycardia
Conditions
Keywords
Hemodynamic response, Elderly patients / age 50 and older, Magnesium sulfate, Fentanyl, Endotracheal intubation, Tachycardia, Hypertension
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.
Detailed 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.
Interventions
DRUGmagnesium sulfate
Magnesium sulfate 30 mg/kg administered intravenously over 10 minutes
DRUGFentanyl (IV)
Fentanyl 2 mcg/kg administered intravenously as a bolus
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Heart Rate (HR) Changes | Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation. | 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. |
| Mean Arterial Pressure (MAP) Changes | Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Train of Four (TOF) Recovery Time | Intraoperatively when TOF count reaches 2. | 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. |
| Perioperative Complications | From immediately after endotracheal intubation up to 15 minutes post-intubation. | Incidence of perioperative complications, including hypotension, hypertension, bradycardia, tachycardia, and arrhythmia, recorded during the first 15 minutes after endotracheal intubation. |
Countries
Turkey (Türkiye)
Outcome results
None listed