Vitrectomy Operation Under General AnesthesiaNCT02212340
Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40 in Vitrectomy
A study testing fresofol and remifentanil and desflurane and remifentanil in people with Vitrectomy Operation Under General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia in vitrectomy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Vitrectomy Operation Under General Anesthesia
- What is being tested?
- fresofol and remifentanil and desflurane and remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Mar 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (20-80 years old) scheduled for vitrectomy surgery undergoing general anesthesia.
- ASA 1-3
Who cannot join
- Patients with allergy to anesthetic agents
- Anticipated difficult airway
- BMI > 30 kg/m2
- Chronic obstructive pulmonary disease
- Heart failure 6. Unstable angina
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia in vitrectomy. In this study, the investigators compare the functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40 questionnaire in vitrectomy.
- Being tested
- fresofol and remifentanil, desflurane and remifentanil
- Keywords
- propofol, desflurane, quality of recovery, vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fresofol and remifentanilDrug
Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.
desflurane and remifentanilDrug
Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Experimental | Anesthesia is maintained with fresofol and remifentanil Receives: Drug: fresofol and remifentanil |
| Des group | Active comparator | Anesthesia is maintained with desflurane and remifentanil 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: at 6 hours later after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitrectomy Operation Under General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 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
- NCT02212340
- Sponsor's protocol ID
- 3-2014-0104
- Status last verified
- Sep 2016
- First submitted
- 6 Aug 2014
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40 in Vitrectomy
- ClinicalTrials.gov ID
- NCT02212340
- Acronym / sponsor ID
- 3-2014-0104
- Keywords
- propofol, desflurane, quality of recovery, vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Aug 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.
Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia in vitrectomy. In this study, the investigators compare the functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40 questionnaire in vitrectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Experimental | Drug: fresofol and remifentanilAnesthesia is maintained with fresofol and remifentanil |
| Des group | Active comparator | Drug: desflurane and remifentanilAnesthesia is maintained with desflurane and remifentanil |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients (20-80 years old) scheduled for vitrectomy surgery undergoing general anesthesia.
- ASA 1-3
Key exclusion criteria (5 listed)
- Patients with allergy to anesthetic agents
- Anticipated difficult airway
- BMI > 30 kg/m2
- Chronic obstructive pulmonary disease
- Heart failure 6. Unstable angina
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 |
|---|---|---|
| fresofol and remifentanilAnesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group. | Drug | TIVA group |
| desflurane and remifentanilAnesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group. | Drug | Des group |
Primary outcome
QoR-40 score
Time frame: at 6 hours later 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 27 Sep 2016.
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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 fresofol and remifentanil and desflurane and remifentanil in people with Vitrectomy Operation Under General 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 2 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 27 Sep 2016. 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: at 6 hours later 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 27 Sep 2016.