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

• Sponsor: Hallym University Kangnam Sacred Heart Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03704441
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 7
• Actual Duration (Months): 22
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Old Age	Drug: Bupivacaine	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients : a Prospective Double-blinded Randomized Trial
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ED50 and ED95 of intrathecal hyperbaric bupivacaine with fentanyl for transurethral prostatectomy in elderly patients [2years]

   ED50(50% Effective dose) and ED95(95% Effective dose) of intrathecal hyperbaric bupivacaine with fentanyl for transurethral prostatectomy in elderly patients

Secondary Outcome Measures

1. comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period [2years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kangnam sacred heart hospital	Seoul	Yeongdeungpo-gu	Korea, Republic of	KS013

Sponsors and Collaborators

• Hallym University Kangnam Sacred Heart Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hallym University Kangnam Sacred Heart Hospital
• ClinicalTrials.gov Identifier: NCT03704441
• Other Study ID Numbers: KangnamAnes
• First Posted: Oct 12, 2018
• Last Update Posted: Mar 21, 2022
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hallym University Kangnam Sacred Heart Hospital: Spinal anesthesia in old age
• Additional relevant MeSH terms: Bupivacaine

Study Results

No Results Posted as of Mar 21, 2022