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Clinical Trials/NCT05525819
NCT05525819
Recruiting
Not Applicable

The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate

Tanta University1 site in 1 country75 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Control group
Conditions
Dexmedetomidine
Sponsor
Tanta University
Enrollment
75
Locations
1
Primary Endpoint
Time to first analgesic request
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

This study was conducted to compare the effects of intrathecal versus intravenous dexmedetomidine administration in patients undergoing Transurethral resection of the prostate under spinal anesthesia.

Detailed Description

Multiple prostatic pathologies become evident in the elderly males. Of them, benign prostatic hyperplasia is one of the most prevalent issues in aging men and transurethral resection of the prostate (TURP) still represents the standard surgical treatment. Most transurethral resection of the prostate (TURP) procedures are performed under spinal anesthesia. Spinal anesthesia has many advantages including, easy application, low cost, decreasing the risk of aspiration, decreasing intraoperative bleeding, eliminating the need for mechanical ventilation together with the decreased risk of intraoperative cardiac events or post-operative hypoxic episode. The management of post-operative pain following spinal anesthesia using a short-acting anesthetic still constitutes a major problem for anesthesiologists and pain physicians. However, the duration and efficacy of spinal anesthesia could be improved by adjuvants. Dexmedetomidine is an alpha 2 receptor agonist that have antinociceptive action for both visceral and somatic pain. At low doses, it has sedative and hypnotic effects without having a negative impact on respiration. Multiple studies have reported that intrathecal and intravenous administration of this drug could prolong the duration of spinal anesthesia and post-operative analgesia.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
April 29, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laila Elahwal

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

Eligibility Criteria

Inclusion Criteria

  • Cases aged between 50 and 70 years
  • Having class I or II according to the American society of anesthesiologists (ASA)

Exclusion Criteria

  • Cases with heart block
  • Dysrhythmia
  • Contraindications for spinal anesthesia
  • Known allergy to the study medications
  • Classified as ASA class \> II
  • Alpha 2 agonist or antagonist therapy.

Arms & Interventions

Control group

Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg.

Intervention: Control group

Intrathecal group

Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg.

Intervention: Intrathecal group

Intravenous group

Cases will receive hyperbaric bupivacaine (10 mg), in addition to IV dexmedetomidine (1 μg/kg loading dose, followed by 0.4 μg/kg/h maintenance dose).

Intervention: Intravenous group

Outcomes

Primary Outcomes

Time to first analgesic request

Time Frame: 24 hours postoperatively

Time to first analgesic request will be recorded

Secondary Outcomes

  • The degree of motor block(24 hours Postoperatively)
  • The onset of sensory(24 hours Postoperatively)
  • Total analgesic requirements(48 hours Postoperatively)
  • Sedation level(Intraoperativley)
  • The incidence of side effects(48 hours Postoperatively)

Study Sites (1)

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