SurgeryNCT01147146
The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery
A study testing propofol, fentanyl, atracurium, bupivacaine and bupivacaine, Midazolam in people with Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The effects of anesthetic method on cerebral oxygen saturation in geriatric patients undergoing transurethral surgery. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Surgery
- What is being tested?
- propofol, fentanyl, atracurium, bupivacaine and bupivacaine, Midazolam
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Dec 2010
- 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 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- male patients (ASA physical status I and II) aged over 65 yrs and scheduled elective transurethral surgery
Who cannot join
- cardiovascular, renal, liver disease, or cerebrovascular disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
The effects of anesthetic method on cerebral oxygen saturation in geriatric patients undergoing transurethral surgery.
- Conditions
- Surgery
- Being tested
- propofol, fentanyl, atracurium, bupivacaine, bupivacaine, Midazolam
- Keywords
- transurethral surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol, fentanyl, atracuriumDrug
Also called propofol 2mg/kg, fentanyl 50mg, atracurium 0.5mg/kg
general anesthesia
bupivacaineDrug
Also called bupivacaine 8-10mg
spinal anesthesia
bupivacaine, MidazolamDrug
Also called Bupivacine 8-10mg, Midazolam 0.5mg/kg
spinal anesthesia \& sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Jeong-Yeon Hong, MD, Principal investigator, Anesthesiology & Pain Medicine, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147146
- Sponsor's protocol ID
- 4-2010-0133
- Status last verified
- May 2011
- First submitted
- 17 Jun 2010
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery
- ClinicalTrials.gov ID
- NCT01147146
- Acronym / sponsor ID
- 4-2010-0133
- Conditions
- Surgery
- Keywords
- transurethral surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jun 2010 (estimated)
- 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.
The effects of anesthetic method on cerebral oxygen saturation in geriatric patients undergoing transurethral surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- male patients (ASA physical status I and II) aged over 65 yrs and scheduled elective transurethral surgery
Key exclusion criteria (1 listed)
- cardiovascular, renal, liver disease, or cerebrovascular disorder
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 |
|---|---|---|
| propofol, fentanyl, atracuriumAlso: propofol 2mg/kg, fentanyl 50mg, atracurium 0.5mg/kggeneral anesthesia | Drug | – |
| bupivacaineAlso: bupivacaine 8-10mgspinal anesthesia | Drug | – |
| bupivacaine, MidazolamAlso: Bupivacine 8-10mg, Midazolam 0.5mg/kgspinal anesthesia \& sedation | Drug | – |
Primary outcome
Not reported in the source record.
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 13 May 2011.
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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.
Jeong-Yeon Hong, MD principal investigator
Anesthesiology & Pain Medicine, Severance 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 propofol, fentanyl, atracurium, bupivacaine and bupivacaine, Midazolam in people with Surgery, run by Yonsei University 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 1 inclusion and 1 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 13 May 2011. 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.
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 13 May 2011.