NCT05525819

Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: Male
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dexmedetomidine
• Transurethral Resection of Prostate
• Analgesia

Interventions

Type	Name	Description
DRUG	Control group	The cases will be subjected to spinal anesthesia with a 3 ml volume (2.5 ml of hyperbaric bupivacaine 10 mg in addition to 0.5 normal saline). 50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation.
DRUG	Intrathecal group	The cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg in the saline component. 50 ml of normal saline was infused over a ten-minute period, followed by 200 ml infusion till the end of operation.
DRUG	Intravenous group	The intravenous group will receive 2.5 ml of hyperbaric bupivacaine (10 mg), in addition to intravenous dexmedetomidine, which will be started at 1 μg/kg loading dose diluted in 50 ml saline administered within 10 min, followed by maintenance at a 0.4 μg/kg/h dose diluted in 200 ml saline till the end of the procedure.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-04-29
• Completion: 2023-04-29
• First posted: 2022-09-02
• Last updated: 2022-09-06

Locations

1 site across 1 country: Egypt