Last reviewed · How we verify
NCT05351489
Effect of Two Different Doses of Intrathecal Dexmedetomidine as Adjuvant in Elderly Patients Undergoing HoLEP
EARLY_PHASE1 trial testing Dexmedetomidine in Transurethral Resection of Prostate in 70 participants. Completed in 31 December 2024.
30 October 2023
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 30 May 2022 |
| Primary completion | 30 October 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Dexmedetomidine (dexmedetomidine) — full drug profile →
Conditions studied
- Transurethral Resection of Prostate — all drugs for Transurethral Resection of Prostate →
Sponsor
Mansoura University
Who can join
Adults 60 to 85, male only, with Transurethral Resection of Prostate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Transurethral resection of the prostate (TURP) is the most common Surgical intervention for elderly patients with benign prostatic hyperplasia. Spinal anesthesia is the technique of choice in TURP.Intrathecal (IT)adjuvants prolong the duration of spinal anesthesia and postoperative analgesia there by reducing the requirement of postoperative supplement analgesics .The incorporation of adjuvants also lowers the overall dose of local anesthetic and associated side effects . The extended analgesic efficacy of intratheacal dexmedetomidine in the postoperative period has been shown in a few clinical studies . These authors have studied different doses (2 - 10 μg) of intrathecal dexametomedine and compared it with various other adjuvants like clonidine, fentanyl, midazolam, buprenorphine, etc., with varying results . The existing studies comparing different doses of intratheacal dexmedetomidine are few. Moreover none of these studies have stressed the dose-response relationship between different doses of intratheacal dexmedetomidine and differential analgesia (DA) defined as the time difference from the offset of motor blockade to the first analgesic requirement on numerical rating scale more than4.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05351489
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dexmedetomidine
Trials testing the same drug.
- NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
- NCT07398066 — DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial) · NA · not yet recruiting
- NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
- NCT07306702 — Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients · Phase 4 · withdrawn
- NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
Other Mansoura University trials
Trials by the same sponsor.
- NCT05785377 — Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia · NA · not yet recruiting
- NCT07509567 — Conventional Palatal Crib Versus Bonded Spurs for Anterior Open Bite Treatment · NA · not yet recruiting
- NCT07393178 — Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones · NA · not yet recruiting
- NCT07436182 — Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. · Phase 4 · not yet recruiting
- NCT07534943 — Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Period · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05351489 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University
- Last refreshed: 9 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05351489.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing