Clinical trial NCT03704441: ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients
Official title: ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients : a Prospective Double-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Age
Keywords: Spinal anesthesia in old age
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 13
Sex: MALE
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ED50 and ED95 of intrathecal hyperbaric bupivacaine with fentanyl for transurethral prostatectomy in elderly patients
timeFrame: 2years
Secondary outcomes:
measure: comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period
timeFrame: 2years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam sacred heart hospital
state: Yeongdeungpo-gu
Study officials:
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Eun Mi Choi, MD
role: STUDY_DIRECTOR
References: