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Effect of Two Different Doses of Intrathecal Dexmedetomidine as Adjuvant in Elderly Patients Undergoing HoLEP

NCT05351489 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-05-09

No results posted yet for this study

Summary

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.

Conditions

  • Transurethral Resection of Prostate

Interventions

DRUG

Dexmedetomidine

Patients will receive intrathecal 2 mL heavy bupivacaine 0. 5% together with either dexmedetomidine 5 μg or10 μg dexmedetomidine .

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mahmoud M Othman, MD · Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university

  • Taha R Elashmawy, BCH · Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2023-10-30
Completion
2024-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351489 on ClinicalTrials.gov