Short StatureNCT02826902
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
A study testing propofol and remifentanil and desflurane and remifentanil in people with Short Stature and Osteoarthritis, run by Yonsei University at 1 site in South Korea.
Trial summary
The effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the quality of recovery from surgery has been reported in several different types of operations. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Short Stature, Osteoarthritis
- What is being tested?
- propofol and remifentanil and desflurane and remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Sep 2016to 9 Nov 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult patients over the age of 19 scheduled for cosmetic lower limg lengthening for short stature, or correctional tibial osteotomy for osteoarthritis
Who cannot join
- Patient refusal
- Patients with altered mental status
- Ejection fraction under 55%
- Recent MI, CVA, or major cardiovascular surgery
- 3rd degree AV block, 2nd degree AV block with P:QRS ration greater than 3:1
- Hemodynamically unstable patients requiring vasopressors or oxygen therapy
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- Febrile patients
- Patients with decreased renal function (serum Cr > 0.1 mg/dL)
- Patients with known allergies to propofol
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
About this study
The effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the quality of recovery from surgery has been reported in several different types of operations. The Quality of Recovery 40 (QoR-40) questionnaire is designed multi-dimensionally to assess the degree of recovery after anesthesia and surgery, and has been validated in previous studies. The present study aims to compare the quality of recovery with the QoR-40 questionnaire, in patients undergoing correctional tibial osteotomy under general anesthesia with either TIVA with propofol or inhalational anesthesia with desflurane.
- Conditions
- Short Stature, Osteoarthritis
- Being tested
- propofol and remifentanil, desflurane and remifentanil
- Keywords
- Total intravenous anesthesia, desflurane, QoR-40, correctional tibial osteotomy
- Medical subject headings
- Dwarfism, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol and remifentanilDrug
Anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil
desflurane and remifentanilDrug
Anesthesia is induced and maintained with desflurane and remifentanil
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Active comparator | Not described Receives: Drug: propofol and remifentanil |
| Inhalation anesthesia group | Active comparator | Not described Receives: Drug: desflurane and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-40 score
Measured: 24 hours after surgery
Secondary outcomes (1)
QoR-40 score
Measured: preoperative period to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start27 Sep 2016
- Primary completion9 Nov 2019
- Study completion9 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short StatureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826902
- Sponsor's protocol ID
- 4-2016-0164
- Status last verified
- Mar 2020
- First submitted
- 6 Jul 2016
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02826902
- Acronym / sponsor ID
- 4-2016-0164
- Conditions
- Short Stature, Osteoarthritis
- Keywords
- Total intravenous anesthesia, desflurane, QoR-40, correctional tibial osteotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 9 Nov 2019 (actual)
- Study completion
- 9 Nov 2019 (actual)
- First posted
- 11 Jul 2016 (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 effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the quality of recovery from surgery has been reported in several different types of operations. The Quality of Recovery 40 (QoR-40) questionnaire is designed multi-dimensionally to assess the degree of recovery after anesthesia and surgery, and has been validated in previous studies. The present study aims to compare the quality of recovery with the QoR-40 questionnaire, in patients undergoing correctional tibial osteotomy under general anesthesia with either TIVA with propofol or inhalational anesthesia with desflurane.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Active comparator | Drug: propofol and remifentanil |
| Inhalation anesthesia group | Active comparator | Drug: desflurane and remifentanil |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult patients over the age of 19 scheduled for cosmetic lower limg lengthening for short stature, or correctional tibial osteotomy for osteoarthritis
Key exclusion criteria (10 listed)
- Patient refusal
- Patients with altered mental status
- Ejection fraction under 55%
- Recent MI, CVA, or major cardiovascular surgery
- 3rd degree AV block, 2nd degree AV block with P:QRS ration greater than 3:1
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 and remifentanilAnesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil | Drug | TIVA group |
| desflurane and remifentanilAnesthesia is induced and maintained with desflurane and remifentanil | Drug | Inhalation anesthesia group |
Primary outcome
QoR-40 score
Time frame: 24 hours after surgery
1 secondary outcome
QoR-40 score
Time frame: preoperative period to 48 hours after surgery
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 16 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and remifentanil and desflurane and remifentanil in people with Short Stature and Osteoarthritis, 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 10 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 16 Mar 2020. 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?
QoR-40 score (time frame: 24 hours after surgery). 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 16 Mar 2020.