General AnesthesiaNCT02515968
Comparison of Desflurane and Propofol on Quality of Recovery in Patients Undergoing Robotic or Laparoscopic Gastrectomy
A study testing Desflurane and Propofol in people with General Anesthesia, run by Yonsei University.
Trial summary
The purpose of this study is to investigate whether propofol can improve quality of recovery compared to desflurane in patients undergoing robotic or laparoscopic gastrectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Desflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients aged over 20 yrs who are scheduled for laparoscopic or robotic gastrectomy, ASA 1 or 2.
Who cannot join
- patients with allergy to anesthetic agents
- body mass index more than 35 kg/m2
- pregnancy
About this study
The purpose of this study is to investigate whether propofol can improve quality of recovery compared to desflurane in patients undergoing robotic or laparoscopic gastrectomy.
- Conditions
- General Anesthesia
- Being tested
- Desflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Anesthesia is maintained with desflurane in Desflurane group according to the randomly allocated groups.
PropofolDrug
Also called Anesthesia is maintained with propofol in Propofol group according to the randomly allocated groups.
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Active comparator | Anesthesia is maintained with desflurane during surgery. Receives: Drug: Desflurane |
| Propofol | Experimental | Anesthesia is maintained with propofol during surgery. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
The quality of recovery will be assessed with QoR-40 score.
Measured: Within 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: The paper is about to publish on the same subject abroad, so the investigator decieded to stopped the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 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
- NCT02515968
- Sponsor's protocol ID
- 4-2015-0509
- Status last verified
- Feb 2019
- First submitted
- 3 Aug 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Desflurane and Propofol on Quality of Recovery in Patients Undergoing Robotic or Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT02515968
- Acronym / sponsor ID
- 4-2015-0509
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The paper is about to publish on the same subject abroad, so the investigator decieded to stopped the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 5 Aug 2015 (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 purpose of this study is to investigate whether propofol can improve quality of recovery compared to desflurane in patients undergoing robotic or laparoscopic gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Active comparator | Drug: DesfluraneAnesthesia is maintained with desflurane during surgery. |
| Propofol | Experimental | Drug: PropofolAnesthesia is maintained with propofol during surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients aged over 20 yrs who are scheduled for laparoscopic or robotic gastrectomy, ASA 1 or 2.
Key exclusion criteria (3 listed)
- patients with allergy to anesthetic agents
- body mass index more than 35 kg/m2
- pregnancy
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 |
|---|---|---|
| DesfluraneAnesthesia is maintained with desflurane in Desflurane group according to the randomly allocated groups. | Drug | Desflurane |
| PropofolAlso: Anesthesia is maintained with propofol in Propofol group according to the randomly allocated groups. | Drug | Propofol |
Primary outcome
Quality of recovery
Time frame: Within 24 hours after the end of surgery
The quality of recovery will be assessed with QoR-40 score.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane and Propofol in people with General Anesthesia, run by Yonsei University.
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 3 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: withdrawn, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Quality of recovery (time frame: Within 24 hours after the end of 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 15 Feb 2019.