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

Overview

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.

Full Title of Study: “ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients : a Prospective Double-blinded Randomized Trial”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: May 31, 2020

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.

Interventions

• Drug: Bupivacaine
  • bupivacaine dose

Arms, Groups and Cohorts

• Other: bupivacaine 6mg
  • bupivacaine 6mg
• Other: bupivacaine 7mg
  • bupivacaine 7mg
• Other: bupivacaine 8mg
  • bupivacaine 8mg
• Other: bupivacaine 9mg
  • bupivacaine 9mg
• Other: bupivacaine 10mg
  • bupivacaine 10mg
• Other: bupivacaine 11mg
  • bupivacaine 11mg
• Other: bupivacaine 12mg
  • bupivacaine 12mg

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

• comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period
  • Time Frame: 2years
  • comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 65 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Hallym University Kangnam Sacred Heart Hospital
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Eun Mi Choi, MD, Study Director, Hallym University Kangnam Sacred Heart Hospital
• Overall Contact(s)
  • Eun Mi Choi, MD, 821090576639, emchoi96@hanmail.net