Old AgeNCT03704441
ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients
A study testing Bupivacaine in people with Old Age, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Old Age
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients scheduled for TURP \& HoLEP under spinal anesthesia
- Male between 65 and 100
- The American Society of Anesthesiologists physical status class 1 or 2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Kangnam sacred heart hospital
Seoul, Yeongdeungpo-gu, KS013
About this study
Official title: ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients : a Prospective Double-blinded Randomized Trial
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.
Read the 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.
- Conditions
- Old Age
- Being tested
- Bupivacaine
- Keywords
- Spinal anesthesia in old age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
bupivacaine dose
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine 6mg | Other | bupivacaine 6mg Receives: Drug: Bupivacaine |
| bupivacaine 7mg | Other | bupivacaine 7mg Receives: Drug: Bupivacaine |
| bupivacaine 8mg | Other | bupivacaine 8mg Receives: Drug: Bupivacaine |
| bupivacaine 9mg | Other | bupivacaine 9mg Receives: Drug: Bupivacaine |
| bupivacaine 10mg | Other | bupivacaine 10mg Receives: Drug: Bupivacaine |
| bupivacaine 11mg | Other | bupivacaine 11mg Receives: Drug: Bupivacaine |
| bupivacaine 12mg | Other | bupivacaine 12mg Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2years
Secondary outcomes (1)
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
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Nov 2018
- Primary completion31 May 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eun Mi Choi, MD, Study director, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704441
- Sponsor's protocol ID
- KangnamAnes
- Status last verified
- Apr 2020
- First submitted
- 1 Aug 2018
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients : a Prospective Double-blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT03704441
- Acronym / sponsor ID
- KangnamAnes
- Conditions
- Old Age
- Keywords
- Spinal anesthesia in old age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| bupivacaine 6mg | Other | Drug: Bupivacainebupivacaine 6mg |
| bupivacaine 7mg | Other | Drug: Bupivacainebupivacaine 7mg |
| bupivacaine 8mg | Other | Drug: Bupivacainebupivacaine 8mg |
| bupivacaine 9mg | Other | Drug: Bupivacainebupivacaine 9mg |
| bupivacaine 10mg | Other | Drug: Bupivacainebupivacaine 10mg |
| bupivacaine 11mg | Other | Drug: Bupivacainebupivacaine 11mg |
| bupivacaine 12mg | Other | Drug: Bupivacainebupivacaine 12mg |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for TURP \& HoLEP under spinal anesthesia
- Male between 65 and 100
- The American Society of Anesthesiologists physical status class 1 or 2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacainebupivacaine dose | Drug | bupivacaine 10mg, bupivacaine 11mg, bupivacaine 12mg, bupivacaine 6mg, bupivacaine 7mg, bupivacaine 8mg, bupivacaine 9mg |
Primary outcome
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
1 secondary outcome
comparison of incidence of complications(hypotension, nausea/vomiting and shivering) during perioperative period
Time frame: 2years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Mi Choi, MD study director
Hallym University Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine in people with Old Age, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED50 and ED95 of intrathecal hyperbaric bupivacaine with fentanyl for transurethral prostatectomy in elderly patients (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.