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

Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704441
• Other study ID #: KangnamAnes
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: April 2020
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 1, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Old Age

Intervention

Drug:
• Bupivacaine
bupivacaine dose

Locations

Country	Name	City	State
Korea, Republic of	Kangnam sacred heart hospital	Seoul	Yeongdeungpo-gu

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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