ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients

Not Applicable

Completed

• Conditions: Old Age
• Interventions: Drug: Bupivacaine

• Registration Number: NCT03704441
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

Brief Summary

As people age, the incidence of prostate hyperplasia increases. So patients under Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP) are mostly ole age people. Most old age patient has several underlying disease. So patients can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes, old age patients can develop severe complication after spinal anesthesia. So we started this study to know the adequate drug concentration for Spinal anesthesia taken for Prostate Resection surgery.

Detailed Description

As people age, the incidence of prostate hyperplasia increases. So patients under Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP) are mostly ole age people. Most old age patient has several underlying disease. So patients can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes, old age patients can develop severe hypotension and vital unstability due to unintentional high sensory and motor blocks. These complications are due to the decreased cerebrospinal fluid volume with increase of age. So we started this study to know the adequate drug concentration for Spinal anesthesia taken for Prostate Resection surgery.

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Study Start: 2018-11-01
• Status Verified: 2020-04
• Primary Completion: 2020-05-31
• Study Completion: 2020-09-01
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

• Patients scheduled for TURP & HoLEP under spinal anesthesia
• Male between 65 and 100
• The American Society of Anesthesiologists physical status class 1 or 2

Exclusion Criteria

• Patients with coagulopathy
• Patients with infectious disease
• Patients with a drug allergy
• Patients under 50kg or over 100kg
• In case of switching to general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine 8mg	Bupivacaine	bupivacaine 8mg
bupivacaine 10mg	Bupivacaine	bupivacaine 10mg
bupivacaine 9mg	Bupivacaine	bupivacaine 9mg
bupivacaine 6mg	Bupivacaine	bupivacaine 6mg
bupivacaine 7mg	Bupivacaine	bupivacaine 7mg
bupivacaine 11mg	Bupivacaine	bupivacaine 11mg
bupivacaine 12mg	Bupivacaine	bupivacaine 12mg

Primary Outcome Measures

Name	Time	Method
ED50 and ED95 of intrathecal hyperbaric bupivacaine with fentanyl for transurethral prostatectomy in elderly patients	2years	ED50(50% Effective dose) and ED95(95% Effective dose) of intrathecal hyperbaric bupivacaine with fentanyl for transurethral prostatectomy in elderly patients

Secondary Outcome Measures

Name	Time	Method
comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period	2years	comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period

Trial Locations

Locations (1)

Kangnam sacred heart hospital; 🇰🇷 Seoul, Yeongdeungpo-gu, Korea, Republic of