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Hemodynamic Effects of Fentanyl Vs Dexmedetomidine in Spine Surgery

NCT07238101 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-20

No results posted yet for this study

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

Conditions

  • Spine Surgery
  • Hemodynamic Stability During Anesthesia

Interventions

DRUG

fentanyl

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.

DRUG

Dexmedetomidine

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.

Sponsors & Collaborators

  • Universitas Sumatera Utara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-08
Primary Completion
2024-09-20
Completion
2025-03-20

Countries

  • Indonesia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07238101 on ClinicalTrials.gov