Hemodynamic Stability During Anesthesia, Spine Surgery
Conditions
Keywords
Dexmedetomidine, Fentanyl, Hemodynamics, Anesthesia, Randomized Controlled Trial, Adam Malik Hospital
Brief summary
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
Detailed 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.
Interventions
DRUGDexmedetomidine
Intravenous administration of dexmedetomidine at a dose of 0.5 μg/kgBW/hour during spinal surgery. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist with sedative and analgesic properties. The aim is to evaluate its effect on maintaining hemodynamic stability, including mean arterial pressure (MAP) and heart rate, during and after anesthesia induction.
DRUGfentanyl
Intravenous administration of fentanyl at a dose of 1.5 μg/kgBW/hour during spinal surgery. Fentanyl is a potent synthetic opioid analgesic used to manage pain and modulate hemodynamic responses during surgery. This group serves as the comparator to evaluate differences in hemodynamic parameters, particularly MAP and heart rate, compared to dexmedetomidine.
Sponsors
Universitas Sumatera Utara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Arterial Pressure (MAP) during spinal surgery | MAP will be recorded at baseline (T0), and at 5, 10, 15, 20, 25, 30, 60, 120, 180, and 240 minutes after drug administration | Measurement of mean arterial pressure (MAP) at multiple time points to compare the effects of dexmedetomidine versus fentanyl on intraoperative hemodynamic stability during spinal surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate (Pulse) during spinal surgery | Heart rate will be recorded at the same time points as MAP: baseline (T0), and at 5, 10, 15, 20, 25, 30, 60, 120, 180, and 240 minutes after drug administration | Measurement of heart rate (pulse) at multiple time points to evaluate hemodynamic response and stability between dexmedetomidine and fentanyl groups. |
Countries
Indonesia
Outcome results
None listed