Hemodynamic Effects of Fentanyl Vs Dexmedetomidine in Spine Surgery

November 14, 2025 updated by: Ida Julita, Universitas Sumatera Utara

Hemodynamic Effects of Fentanyl and Dexmedetomidine in Spine Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • North Sumatra
      • Medan, North Sumatra, Indonesia, 20222
        • Faculty of Medicine, Universitas Sumatera Utara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine Group
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.
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.
Experimental: Fentanyl Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Arterial Pressure (MAP) during spinal surgery
Time Frame: 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.
MAP will be recorded at baseline (T0), and at 5, 10, 15, 20, 25, 30, 60, 120, 180, and 240 minutes after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate (Pulse) during spinal surgery
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sumatera Utara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

March 20, 2025

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 216 /KEPK/USU/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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