Intrathecal Versus Intravenous Dexmedetomidine in Prostate Transurethral Resection

Study 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.

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

Conditions
-----------------
Dexmedetomidine, Transurethral Resection of Prostate, Analgesia

Intervention / Treatment
-----------------
* Drug: Control group
* Drug: Intrathecal group
* Drug: Intravenous group


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg. | Drug: Control group<br>* 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.<br>|
| Experimental: Intrathecal group<br>Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg. | Drug: Intrathecal group<br>* 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.<br>|
| Experimental: Intravenous group<br>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). | Drug: Intravenous group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic request | Time to first analgesic request will be recorded | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The onset of sensory | Time to reach T7 sensory block will be recorded | 24 hours Postoperatively | 
| The degree of motor block | 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. | 24 hours Postoperatively | 
| Sedation level | Patients level of sedation will be assessed via Ramsay sedation score. This score is numbered from 1 to 6, based on patient responsiveness. | Intraoperativley | 
| Total analgesic requirements | Total analgesic requirements will be recorded | 48 hours Postoperatively | 
| The incidence of side effects | The incidence of side effects including (bradycardia, hypotension, nausea, vomiting, and pruritis) will be recorded.. | 48 hours Postoperatively |