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Researchers will compare dexmedetomidine to fentanyl to see which drug provides better hemodynamic stability during spinal surgery.
Participants will :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Universitas Sumatera Utara | Medan | North Sumatra | 20222 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35645714 | Result | 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. | |
| 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2025 | Nov 14, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
|
| 28332374 | 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. |
| 27510395 | 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. |
| 32240402 | 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. |
| 33116789 | 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. |
| 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. |
| 35668701 | 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. |
| D010880 |
| Piperidines |