Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

Tanta University

Status: Enrolling

Conditions: Dexmedetomidine; Transurethral Resection of Prostate; Analgesia

Treatments: Drug: Intravenous group; Drug: Intrathecal group; Drug: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05525819

34141/9/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Control group

Experimental group

Description:

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

Treatment:

Drug: Control group

Intrathecal group

Experimental group

Description:

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

Treatment:

Drug: Intrathecal group

Intravenous group

Experimental group

Description:

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).

Treatment:

Drug: Intravenous group