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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Old Age

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: bupivacaine 6mg<br>bupivacaine 6mg | Drug: Bupivacaine<br>* bupivacaine dose<br>|
| Other: bupivacaine 7mg<br>bupivacaine 7mg | Drug: Bupivacaine<br>* bupivacaine dose<br>|
| Other: bupivacaine 8mg<br>bupivacaine 8mg | Drug: Bupivacaine<br>* bupivacaine dose<br>|
| Other: bupivacaine 9mg<br>bupivacaine 9mg | Drug: Bupivacaine<br>* bupivacaine dose<br>|
| Other: bupivacaine 10mg<br>bupivacaine 10mg | Drug: Bupivacaine<br>* bupivacaine dose<br>|
| Other: bupivacaine 11mg<br>bupivacaine 11mg | Drug: Bupivacaine<br>* bupivacaine dose<br>|
| Other: bupivacaine 12mg<br>bupivacaine 12mg | Drug: Bupivacaine<br>* bupivacaine dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal anesthesia in old age