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

NCT05351489 | Completed Early Phase 1 DMC

• 1 other identifier: MS.22.04.157
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The duration of analgesia

  Duration of spinal analgesia till analgesic rescue.

  perioperative time for 24 hours

Secondary Outcomes (6)

• Total dose of analgesic requirements .

  perioperative time for 24 hours

• Hemodynamic stability perioperatively.

  perioperative time for 24 hours

• Onset of sensory block after spinal anesthesia .

  Immediate after spinal anesthesia

• Dose of vasopressors required

  perioperative time for two hours postoperatively

• Perioperative hypotension

  Perioperative time for 24 hours postoperatively

Study Arms (2)

Dexmedetomidine 5 μg group (D5 group )

EXPERIMENTAL

Dexmedetomidine 5 μg group (D5 group ): Patients will receive 2 mL heavy bupivacaine 0.5% and Dexmedetomidine 5 μg intrathecal.

Drug: Dexmedetomidine

Dexmedetomidine 10 μg group (D10 group )

ACTIVE COMPARATOR

dexmedetomidine 10 μg group (D10 group ): Patients will receive 2 mL heavy bupivacaine 0.5% and Dexmedetomidine 10 μg intrathecal .

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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

Also known as: Group (D 5):Patients will receive intrathecal 2 mL heavy bupivacaine 0. 5% together with dexmedetomidine 5 μg dexmedetomidine ., Group (D10):Patients will receive intrathecal 2 mL heavy bupivacaine 0. 5% together with dexmedetomidine 10 μg dexmedetomidine

Dexmedetomidine 10 μg group (D10 group ); Dexmedetomidine 5 μg group (D5 group )

Eligibility Criteria

• Age: 60 Years - 85 Years
• Gender Eligibility Details: Study will carried out for elderly male patients undergoing transuretheral resection of prostate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly patients undergoing transurtheral resection of Prostate.
• American Society of Anesthesiologists (ASA) physical status I/II

You may not qualify if:

• Any contraindication to subarachnoid block.
• On chronic analgesic therapy.
• Patients refuse to contribute in the study.
• Cognitive impairment.
• Not able to understand numerical rating pain scale (NRS). 6.-Significant comorbid conditions like uncontrolled hypertension, congestive heart failure myocardial infarction in the past 6 months..

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Population Groups

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Demography; Population Characteristics

Study Officials

• Mahmoud M Othman, MD

  Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university

  PRINCIPAL INVESTIGATOR

• Taha R Elashmawy, BCH

  Department of anesthesia ,Urology and nephrology center ,Faculty of medicine,Mansoura university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double- blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor of anesthesia and surgical Intensive care

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 28, 2022
• Study Start: May 30, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year
• Access Criteria: Pubmed

Locations

EG (1)