Intrathecal Versus Intravenous Dexmeditomedine in Transurethral Resection of the Prostate

Tanta University

Status and phase: Unknown; Phase 4

Conditions: Intrathecal; Intravenous; Dexmedetomidine; Transurethral Resection of Prostate

Treatments: Drug: Intravenous dexmedetomidine; Drug: Intrathecal dexmedetomidine; Drug: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04618965

Pain relief for prostatictomy

Details and patient eligibility

About

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

Full 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

Enrollment: 75 estimated patients

Sex: Male

Ages: 59 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

Control (Placebo) group

Placebo Comparator group

Description:

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.

Treatment:

Drug: control group

Intrathecal dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Intrathecal dexmedetomidine

Intravenous dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Intravenous dexmedetomidine