Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

Not Applicable

Recruiting

• Conditions: Dexmedetomidine; Transurethral Resection of Prostate; Analgesia
• Interventions: Drug: Control group; Drug: Intrathecal group; Drug: Intravenous group

• Registration Number: NCT05525819
• Lead Sponsor: Tanta University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-30
• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Posted: 2022-09-02
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-06
• Primary Completion: 2023-04-29
• Study Completion: 2023-04-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 75

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg.
Intrathecal group	Intrathecal group	Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg.
Intravenous 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).

Primary Outcome Measures

Name	Time	Method
Time to first analgesic request	24 hours postoperatively	Time to first analgesic request will be recorded

Secondary Outcome Measures

Name	Time	Method
The degree of motor block	24 hours Postoperatively	The degree of motor block will be assessed using the modified Bromage Score. Grade 0 No motor block Grade 1 Inability to raise extended leg, able to move knees and feet Grade 2 Inability to raise extended leg and move knee, able to move feet Grade 3 Complete motor block of the lower limbs.
The onset of sensory	24 hours Postoperatively	Time to reach T7 sensory block will be recorded
Total analgesic requirements	48 hours Postoperatively	Total analgesic requirements will be recorded
Sedation level	Intraoperativley	Patients level of sedation will be assessed via Ramsay sedation score. This score is numbered from 1 to 6, based on patient responsiveness.
The incidence of side effects	48 hours Postoperatively	The incidence of side effects including (bradycardia, hypotension, nausea, vomiting, and pruritis) will be recorded..

Trial Locations

Locations (1)

Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt; 🇪🇬 Tanta, ElGharbia, Egypt