Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620614
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study on Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine in Patients Undergoing Transurethral Resection of Prostate Surgery Under Subarachnoid Block
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ProstateTURP surgery under Subarachnoid blockSAB
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 05 hyperbaric bupivacaine 25 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially ie 16 ml and remaining one third dose ie 09 ml after 60 seconds at the rate of 02mlsec
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 05 hyperbaric bupivacaine 25 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially ie 16 ml and remaining one third dose ie 09 ml after 60 seconds at the rate of 02mlsec
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 05 hyperbaric bupivacaine 25 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially ie 16 ml and remaining one third dose ie 09 ml after 60 seconds at the rate of 02mlsec
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
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 05 hyperbaric bupivacaine 25 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially ie 16 ml and remaining one third dose ie 09 ml after 60 seconds at the rate of 02mlsec
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None