Surgery Related to Lower Extremity Under Spinal AnesthesiaNCT02173340
Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol
An observational study of Surgery Related to Lower Extremity Under Spinal Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent bolus of sedative frequently results in inappropriate sedation which comes with various side effects such as patients' discomfort and apnea. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Surgery Related to Lower Extremity Under Spinal Anesthesia
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Sep 2014
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who have lower extremity surgery under spinal anesthesia at Gangnam Severance Hospital
Who may be able to join
- patients who have lower extremity surgery under spinal anesthesia and who want to be sedated
Who cannot join
- patients who have deafness, neurologic deficit, Glasgow coma scale less than 15, history of drug allergy and who are on central nervous system-related drugs,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol in Patients Undergoing Spinal Anesthesia
Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent bolus of sedative frequently results in inappropriate sedation which comes with various side effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use target-controlled infusion(TCI) to provide proper sedation without serious side effects.
In this study, the investigators try to find the appropriate propofol target concentration with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol target concentration and side effects.
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation score
Sedation score will be assessed with 'Modified Observer's assessment of alertness/sedation (OAA/S) score'. It has 5 scales from 1 to 5 as followed.
- responds readily to name spoken in normal tone
- lethargic response to name spoken in normal tone
- responds only after name is spoken loudly and/or repeatedly
- responds only after mild prodding or shaking
- does not respond to mild prodding or shaking
After induction of spinal anesthesia, patient will be sedated with propofol via TCI device. The infusion dose will be adjusted every 5 minutes until the OAA/S score reaches 4. The patient's OAA/S score will be assessed overtime the infusion dose is adjusted during sedation. At the same time, airway obstruction score will be assessed and if the score reaches 4, the dose will be reduced.
Measured: every 5 minutes when the dose is adjusted up to 1 hour
Secondary outcomes (1)
airway obstruction score
Airway obstruction score will be assessed as followed.
- normal breathing
- deep breathing
- snoring
- severe airway obstruction
After induction of spinal anesthesia, patient will be sedated with propofol via TCI device. The infusion dose will be adjusted every 5 minutes until the OAA/S score reaches 4. The patient's OAA/S score will be assessed overtime the infusion dose is adjusted during sedation. At the same time, airway obstruction score will be assessed and if the score reaches 4, the dose will be reduced.
Measured: every 5 minutes when the dose is adjusted up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery Related to Lower Extremity Under Spinal AnesthesiaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Woo Han, MD, PhD, Principal investigator, Yonsei University Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173340
- Sponsor's protocol ID
- 3-2011-0247
- Status last verified
- Jul 2015
- First submitted
- 19 May 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol in Patients Undergoing Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02173340
- Acronym / sponsor ID
- 3-2011-0247
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Jun 2014 (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.
Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent bolus of sedative frequently results in inappropriate sedation which comes with various side effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use target-controlled infusion(TCI) to provide proper sedation without serious side effects.
In this study, the investigators try to find the appropriate propofol target concentration with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol target concentration and side effects.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have lower extremity surgery under spinal anesthesia at Gangnam Severance Hospital
Key inclusion criteria (1 listed)
- patients who have lower extremity surgery under spinal anesthesia and who want to be sedated
Key exclusion criteria (1 listed)
- patients who have deafness, neurologic deficit, Glasgow coma scale less than 15, history of drug allergy and who are on central nervous system-related drugs,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sedation score
Time frame: every 5 minutes when the dose is adjusted up to 1 hour
Sedation score will be assessed with 'Modified Observer's assessment of alertness/sedation (OAA/S) score'. It has 5 scales from 1 to 5 as followed. 1. responds readily to name spoken in normal tone 2. lethargic response to name spoken in normal tone 3. responds only after name is spoken loudly and/or repeatedly 4. responds only after mild prodding or shaking 5. does not respond to mild prodding or shaking After induction of spinal anesthesia, patient will be sedated with propofol via TCI device. The infusion dose will be adjusted every 5 minutes until the OAA/S score reaches 4. The patient's OAA/S score will be assessed overtime the infusion dose is adjusted during sedation. At the same time, airway obstruction score will be assessed and if the score reaches 4, the dose will be reduced.
1 secondary outcome
airway obstruction score
Time frame: every 5 minutes when the dose is adjusted up to 1 hour
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 29 Jul 2015.
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.
Dong Woo Han, MD, PhD principal investigator
Yonsei University Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery Related to Lower Extremity Under Spinal Anesthesia, 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 29 Jul 2015. 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?
sedation score (time frame: every 5 minutes when the dose is adjusted up to 1 hour). 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 29 Jul 2015.