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

Hallym University Kangnam Sacred Heart Hospital

Status: Completed

Conditions: Old Age

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03704441

KangnamAnes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Male

Ages: 65 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

13 participants in 7 patient groups

bupivacaine 6mg

Other group

Description:

bupivacaine 6mg

Treatment:

Drug: Bupivacaine

bupivacaine 7mg

Other group

Description:

bupivacaine 7mg

Treatment:

Drug: Bupivacaine

bupivacaine 8mg

Other group

Description:

bupivacaine 8mg

Treatment:

Drug: Bupivacaine

bupivacaine 9mg

Other group

Description:

bupivacaine 9mg

Treatment:

Drug: Bupivacaine

bupivacaine 10mg

Other group

Description:

bupivacaine 10mg

Treatment:

Drug: Bupivacaine

bupivacaine 11mg

Other group

Description:

bupivacaine 11mg

Treatment:

Drug: Bupivacaine

bupivacaine 12mg

Other group

Description:

bupivacaine 12mg

Treatment:

Drug: Bupivacaine