Hemodynamic Effects of Fentanyl Vs Dexmedetomidine in Spine Surgery

NCT07238101 | Completed Phase 4 DMC

• 1 other identifier: 216 /KEPK/USU/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Spine Surgery; Hemodynamic Stability During Anesthesia

Keywords

Dexmedetomidine; Fentanyl; Hemodynamics; Anesthesia; Randomized Controlled Trial; Adam Malik Hospital

Outcome Measures

Primary Outcomes (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.

  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)

• 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

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

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

Fentanyl Group

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine Group

fentanyl DRUG

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.

Fentanyl Group

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Faculty of Medicine, Universitas Sumatera Utara

Medan, North Sumatra, 20222, Indonesia

Location

Related Publications (13)

• Gilpin B. Changing the public health landscape through advocacy. Circulation. 1997 Apr 15;95(8):1978. doi: 10.1161/01.cir.95.8.1978. No abstract available.

  PMID: 9133498 RESULT

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

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 28332374 RESULT

• 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.

  PMID: 27510395 RESULT

• 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.

  PMID: 32240402 RESULT

• 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.

  PMID: 33116789 RESULT

• 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).

  RESULT

• 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

  RESULT

• 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).

  RESULT

• 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.

  RESULT

• 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.

  PMID: 35668701 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 20, 2025
• Study Start: May 8, 2024
• Primary Completion: September 20, 2024
• Study Completion: March 20, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)