Hemodynamic Effects of Fentanyl Vs Dexmedetomidine in Spine Surgery

Universitas Sumatera Utara

Status and phase: Completed; Phase 4

Conditions: Spine Surgery; Hemodynamic Stability During Anesthesia

Treatments: Drug: Dexmedetomidine; Drug: fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT07238101

216 /KEPK/USU/2024

Details and patient eligibility

About

Researchers will compare dexmedetomidine to fentanyl to see which drug provides better hemodynamic stability during spinal surgery.

Participants will :

• Receive either dexmedetomidine or fentanyl as part of their anesthesia during elective surgery
• Have their mean arterial pressure and heart rate measured at several time points during the procedure
• Be monitored throughout surgery to assess intraoperative hemodynamic responses and stability

Full description

Spinal surgery is frequently associated with perioperative hemodynamic fluctuations and significant postoperative pain. Maintaining stable intraoperative blood pressure and heart rate is essential to minimize surgical bleeding, protect neural structures, and promote optimal recovery. Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, provides sedation, analgesia, and sympatholytic effects without causing respiratory depression and may contribute to improved cardiovascular stability during anesthesia. Fentanyl, a potent synthetic opioid, is widely utilized as an analgesic adjunct in general anesthesia but may offer less consistent hemodynamic control.

This study is a prospective, interventional, randomized, double-blind controlled trial conducted at Adam Malik General Hospital, Medan, Indonesia, following approval from the institutional ethics committee. A total of 50 adult patients scheduled for elective spinal surgery under general anesthesia were enrolled using consecutive sampling and randomly assigned to receive either dexmedetomidine or fentanyl as part of intraoperative management.

Eligible participants were aged 17-60 years and classified as American Society of Anesthesiologists (ASA) physical status I-III. Patients with known drug hypersensitivity, significant cardiac or vascular abnormalities, or contraindications to the study drugs were excluded.

Hemodynamic parameters, including mean arterial pressure (MAP) and heart rate, were recorded at baseline (T0) and at predetermined intraoperative time points (T1-T12). The primary outcome measure was intraoperative MAP, while secondary outcomes included heart rate and estimated blood loss. Statistical analyses were performed using independent t-tests or Wilcoxon rank-sum tests, with a significance threshold of p < 0.05.

Enrollment: 50 patients

Sex: All

Ages: 17 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 17 and 60 years old
• Classified as ASA physical status 1-3
• Scheduled for elective spinal surgery
• Provided written informed consent

Exclusion criteria

• History of drug hipersensitivity to fentanyl or dexmetomidine
• Presence of Cardiac Anatomical abnormalities
• Vsacular disorders or other conditions that may interfere with the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Dexmedetomidine Group

Experimental group

Description:

Participants in this group received dexmedetomidine at a dose of 0.5 μg/kgBW/hour intravenously as part of anesthesia management for spinal surgery. The purpose is to evaluate the effect of dexmedetomidine on hemodynamic stability, including heart rate and mean arterial pressure, during and after induction of anesthesia.

Treatment:

Drug: Dexmedetomidine

Fentanyl Group

Experimental group

Description:

Participants in this group received fentanyl at a dose of 1.5 μg/kgBW/hour intravenously as part of anesthesia management for spinal surgery. This arm serves as the comparison group to evaluate differences in hemodynamic parameters such as heart rate and mean arterial pressure compared to dexmedetomidine.

Treatment:

Drug: fentanyl