NCT03704441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 21, 2022

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

August 1, 2018

Last Update Submit

March 18, 2022

Conditions

Old Age

Keywords

Spinal anesthesia in old age

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period

    2years

Study Arms (7)

bupivacaine 6mg

OTHER

bupivacaine 6mg

Drug: Bupivacaine

bupivacaine 7mg

OTHER

bupivacaine 7mg

Drug: Bupivacaine

bupivacaine 8mg

OTHER

bupivacaine 8mg

Drug: Bupivacaine

bupivacaine 9mg

OTHER

bupivacaine 9mg

Drug: Bupivacaine

bupivacaine 10mg

OTHER

bupivacaine 10mg

Drug: Bupivacaine

bupivacaine 11mg

OTHER

bupivacaine 11mg

Drug: Bupivacaine

bupivacaine 12mg

OTHER

bupivacaine 12mg

Drug: Bupivacaine

Interventions

BupivacaineDRUG

bupivacaine dose

bupivacaine 10mgbupivacaine 11mgbupivacaine 12mgbupivacaine 6mgbupivacaine 7mgbupivacaine 8mgbupivacaine 9mg

Eligibility Criteria

Age65 Years - 100 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangnam sacred heart hospital

Seoul, Yeongdeungpo-gu, KS013, South Korea

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Eun Mi Choi, MD

    Hallym University Kangnam Sacred Heart Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

October 12, 2018

Study Start

November 1, 2018

Primary Completion

May 31, 2020

Study Completion

September 1, 2020

Last Updated

March 21, 2022

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)