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Trial record 57 of 151 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

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

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ClinicalTrials.gov Identifier: NCT03704441
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hallym University Kangnam Sacred Heart Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
bupivacaine 6mg
bupivacaine 6mg
Drug: Bupivacaine
bupivacaine dose

bupivacaine 7mg
bupivacaine 7mg
Drug: Bupivacaine
bupivacaine dose

bupivacaine 8mg
bupivacaine 8mg
Drug: Bupivacaine
bupivacaine dose

bupivacaine 9mg
bupivacaine 9mg
Drug: Bupivacaine
bupivacaine dose

bupivacaine 10mg
bupivacaine 10mg
Drug: Bupivacaine
bupivacaine dose

bupivacaine 11mg
bupivacaine 11mg
Drug: Bupivacaine
bupivacaine dose

bupivacaine 12mg
bupivacaine 12mg
Drug: Bupivacaine
bupivacaine dose




Primary Outcome Measures :
  1. ED50 and ED95 of intrathecal hyperbaric bupivacaine with fentanyl for transurethral prostatectomy in elderly patients [ Time Frame: 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 [ Time Frame: 2years ]
    comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period



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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704441


Contacts
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Contact: Eun Mi Choi, MD 821090576639 emchoi96@hanmail.net

Locations
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Korea, Republic of
Kangnam sacred heart hospital Recruiting
Seoul, Yeongdeungpo-gu, Korea, Republic of, KS013
Contact: Eun Mi Choi, MD    821090576639    Emchoi96@hanmail.net   
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
Investigators
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Study Director: Eun Mi Choi, MD Hallym University Kangnam Sacred Heart Hospital

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Responsible Party: Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03704441     History of Changes
Other Study ID Numbers: KangnamAnes
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General