Intrathecal Versus Intravenous Dexmeditomedine in Transurethral Resection of the Prostate

Phase 4

• Conditions: Intrathecal; Dexmedetomidine; Transurethral Resection of Prostate; Intravenous
• Interventions: Drug: control group; Drug: Intrathecal dexmedetomidine; Drug: Intravenous dexmedetomidine

• Registration Number: NCT04618965
• Lead Sponsor: Tanta University

Brief Summary

This study is to evaluate The analgesic effect of intrathecal versus intravenous dexmeditomedine in transurethral resection of the prostate

Detailed Description

This study will carried out in Tanta University hospital on75 male patients Patients will randomly classified into 3 groups Group I: will receive intrathecal hyperbaric bupivacaine 10mg in 2.5 ml and .5 ml saline with 3ml total volume Group II: will receive dexmeditomedine 5Mic diluted in.5 ml saline and hyperbaric bupivacaine 10mg in 2.5ml with 3ml total volume Group IIl: Will receive intravenous dexmeditomedine started at loading dose of 1 mic/kg diluted in 50 ml saline and administered within 10 min as loading dose , followed by maintenance at a dose of .4mic/kg/h diluted in200 ml saline till the end of surgery and hyperbaric bupivacaine 10 mg in 2.5 ml total volume

Study Timeline

• Study First Submitted: 2020-10-26
• Status Verified: 2020-11
• Study Start: 2020-11-01
• Study First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-05
• Study First Posted: 2020-11-06
• Last Update Posted: 2020-11-06
• Primary Completion: 2021-04-26
• Study Completion: 2021-06-26

Recruitment & Eligibility

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

Inclusion Criteria

• male gender
• 50:70years old
• ASA:I,II

Exclusion Criteria

• contraindications of spinal anesthesia
• Patient refusal
• Patient taking alpha agonist or antagonist
• Uncontrolled cardiac diseases
• Allergy to local anesthetic drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Placebo) group	control group	Each patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
Intrathecal dexmedetomidine group	Intrathecal dexmedetomidine	Each patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
Intravenous dexmedetomidine group	Intravenous dexmedetomidine	Each patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume.

Primary Outcome Measures

Name	Time	Method
The time to first rescue analgesic	24 hours postoperative	The duration between the administration of spinal block and the first desire for supplemental analgesia (onset of 1st post-operative analgesic dose).; First post-operative analgesic dose will be1 μg/kg intravenous fentanyl when visual analogue pain score (VAS) is 4 or more

Secondary Outcome Measures

Name	Time	Method
Intraoperative and postoperative complications	Intraoperative and 24 hours postoperative	e.g. hypotension, bradycardia and vomiting
Postoperative pain score Total dose of analgesic consumption I the first postoperative day Intraoperative and postoperative complications	24 hours postoperative	Visual analogue score (VAS) between 0 and 10{0= no pain, 10=most severe pain}
Total analgesic consumption	24 hours postoperative	The pain score will be assessed every 4 h in 24 h and fentanyl will be given in a dose of 1 μg /kg when Visual analogue score (VAS) is 4 or more. Any out breaking pain will be treated with increments of fentanyl in a dose of 0.5μg/kg.