Clinical trial NCT05525819: Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection
Official title: The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dexmedetomidine
Transurethral Resection of Prostate
Analgesia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 75
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to first analgesic request
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: The onset of sensory
timeFrame: 24 hours Postoperatively
measure: The degree of motor block
timeFrame: 24 hours Postoperatively
measure: Sedation level
timeFrame: Intraoperativley
measure: Total analgesic requirements
timeFrame: 48 hours Postoperatively
measure: The incidence of side effects
timeFrame: 48 hours Postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt
state: ElGharbia
Study officials:
References: