NCT06620614

A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group.

Comparative Study on Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine in Patients Undergoing Transurethral Resection of Prostate Surgery Under Subarachnoid Block.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: National Academy of Medical Sciences, Nepal · Other Government
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing Transurethral Resection of Prostate(TURP) surgery under Subarachnoid block(SAB). Seventy-two patients aged 50 years and above belonging to American Physical status I and II are divided into two study group. Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.

Detailed description

The aim of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing TURP surgery under SAB. Seventy-two patients aged 50 years and above belonging to American Physical status I and II undergoing transurethral resection of prostate for benign enlargement of prostate under subarachnoid block are enrolled and are divided into two groups having 36 patients in each. Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec. Intraoperative mean arterial pressure (MAP), heart rate, onset of sensory and motor block, duration of sensory and motor block, and total intraoperative consumption of vasopressor are observed and compared between the groups.

Conditions

• Prostatic Hyperplasia, Benign

Interventions

Type	Name	Description
COMBINATION_PRODUCT	0.5% Heavy Bupivacaine	There are two groups.

Timeline

• Start date: 2022-10-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2024-10-01
• Last updated: 2024-10-08

Locations

1 site across 1 country: Nepal

Regulatory

• FDA-regulated device study