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NCT Number: NCT03704441

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

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.

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Key information

Conditions

Old Age

Age range

65 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kangnam sacred heart hospital

Seoul, Yeongdeungpo-gu, KS013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

bupivacaine dose

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 12, 2018
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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