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Spine SurgeryPhase 4NCT07238101

Hemodynamic Effects of Fentanyl Vs Dexmedetomidine in Spine Surgery

A Phase 4 study testing Dexmedetomidine and fentanyl in people with Spine Surgery and Hemodynamic Stability During Anesthesia, run by Universitas Sumatera Utara at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 17 to 60 years
What is being tested?
Dexmedetomidine and fentanyl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndonesia
Study dates
8 May 2024to 20 Mar 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Indonesia1 site

  • Faculty of Medicine, Universitas Sumatera Utara

    Medan, North Sumatra, 20222

Other trials in Indonesia

About this study

Official title: 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
Read the 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.

Keywords
Dexmedetomidine, Fentanyl, Hemodynamics, Anesthesia, Randomized Controlled Trial, Adam Malik Hospital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    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.

  • fentanylDrug

    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.

Study groups in NCT07238101
Study groupRoleWhat they receive
Dexmedetomidine GroupExperimentalParticipants 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.
Receives: Drug: Dexmedetomidine
Fentanyl GroupExperimentalParticipants 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.
Receives: Drug: fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mean Arterial Pressure (MAP) during spinal surgery

    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.

    Measured: 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 outcomes (1)

  1. Change in Heart Rate (Pulse) during spinal surgery

    Measurement of heart rate (pulse) at multiple time points to evaluate hemodynamic response and stability between dexmedetomidine and fentanyl groups.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start8 May 2024
  3. Primary completion20 Sep 2024
  4. Study completion20 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07238101
Sponsor's protocol ID
216 /KEPK/USU/2024
Status last verified
Sep 2025
First submitted
23 Sep 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang L, Li H, Deng L, Fang K, Cao Y, Huang C, Gu E, Li J. Electroencephalogram Mechanism of Dexmedetomidine Deepening Sevoflurane Anesthesia. Front Neurosci. 2022 May 12;16:913042. doi: 10.3389/fnins.2022.913042. eCollection 2022.

    PubMed 35645714

  • Hasmi. Epidemiological research methods. Jakarta: CV Trans Info Media; 2016.

  • Rizkiya P, Margarita N, Harijono B, Herawati L. Analysis of dexmedetomidine addition in elective major spinal surgery in RSUD Dr. Soetomo. Maj Anestesiol Indones. 2020;9(2):1-9.

  • Yun SH, Song SW, Park JC. Beneficial effects of the addition of intrathecal fentanyl to bupivacaine for spinal anesthesia in cesarean section. Anesth Pain Med (Seoul). 2017;12(3):233-239. doi:10.17085/apm.2017.12.3.233.

  • Park SJ, Shin S, Kim SH, Kim HW, Kim SH, Do HY, Choi YS. Comparison of Dexmedetomidine and Fentanyl as an Adjuvant to Ropivacaine for Postoperative Epidural Analgesia in Pediatric Orthopedic Surgery. Yonsei Med J. 2017 May;58(3):650-657. doi: 10.3349/ymj.2017.58.3.650.

    PubMed 28332374

  • Choi JW, Joo JD, Kim DW, In JH, Kwon SY, Seo K, Han D, Cheon GY, Jung HS. Comparison of an Intraoperative Infusion of Dexmedetomidine, Fentanyl, and Remifentanil on Perioperative Hemodynamics, Sedation Quality, and Postoperative Pain Control. J Korean Med Sci. 2016 Sep;31(9):1485-90. doi: 10.3346/jkms.2016.31.9.1485.

    PubMed 27510395

  • Kaye AD, Chernobylsky DJ, Thakur P, Siddaiah H, Kaye RJ, Eng LK, Harbell MW, Lajaunie J, Cornett EM. Dexmedetomidine in Enhanced Recovery After Surgery (ERAS) Protocols for Postoperative Pain. Curr Pain Headache Rep. 2020 Apr 2;24(5):21. doi: 10.1007/s11916-020-00853-z.

    PubMed 32240402

  • Khosravi F, Sharifi M, Jarineshin H. Comparative Study of Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in Cesarean Section: A Randomized, Double-Blind Clinical Trial. J Pain Res. 2020 Oct 7;13:2475-2482. doi: 10.2147/JPR.S265161. eCollection 2020.

    PubMed 33116789

  • Sahraei R, Ghaedi M, Haghbeen M, Sadegh M, Jahromi S. Comparison of ketamine and dexmedetomidine in reducing complications after laparoscopic cholecystectomy surgery. Med J Islam Repub Iran. 2023;12(2).

  • Emam MWM, Hassan BEDE, Abd El-Hamid HM, Ibrahim IA, Saleh MAE. Comparative study between dexmedetomidine and fentanyl as adjuvants to bupivacaine for postoperative epidural analgesia in abdominal surgery: a randomized controlled trial. Egypt J Anaesth. 2023;39(1):635-641. doi:10.1080/11101849.2023.2238520

  • Sigdel R, Lama M, Gurung S, et al. Intrathecal bupivacaine with fentanyl versus bupivacaine alone in cases undergoing elective cesarean section: comparison of hemodynamics. J Nepal Health Res Counc. 2023;21(2).

  • Hassanin AAM, Ali NS, Elhiny MMMA. Effect of dexmedetomidine versus fentanyl on recovery responses to tracheal extubation in vitrectomy: randomized controlled trial. Egypt J Anaesth. 2023;39(1):40-49. doi:10.1080/11101849.2023.2166617.

  • Ma RX, Qiao RQ, Xu MY, Li RF, Hu YC. Application of Controlled Hypotension During Surgery for Spinal Metastasis. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221105718. doi: 10.1177/15330338221105718.

    PubMed 35668701

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and fentanyl in people with Spine Surgery and Hemodynamic Stability During Anesthesia, run by Universitas Sumatera Utara at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07238101, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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