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

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

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.

Study Overview

• Status: Completed
• Conditions: Old Age
• Intervention / Treatment: Drug: Bupivacaine

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yeongdeungpo-gu
    • Seoul, Yeongdeungpo-gu, Korea, Republic of, KS013
      • KangNam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: bupivacaine 6mg	Drug: Bupivacaine; bupivacaine dose
Other: bupivacaine 7mg	Drug: Bupivacaine; bupivacaine dose
Other: bupivacaine 8mg	Drug: Bupivacaine; bupivacaine dose
Other: bupivacaine 9mg	Drug: Bupivacaine; bupivacaine dose
Other: bupivacaine 10mg	Drug: Bupivacaine; bupivacaine dose
Other: bupivacaine 11mg	Drug: Bupivacaine; bupivacaine dose
Other: bupivacaine 12mg	Drug: Bupivacaine; bupivacaine dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• Investigators: Study Director: Eun Mi Choi, MD, Hallym University Kangnam Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Spinal anesthesia in old age
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: KangnamAnes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No