Breast AugmentationNCT04036487
Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation
A study testing Desflurane and Propofol in people with Breast Augmentation and Inhalation Anesthesia, run by Chih-Cheng Hung at 1 site in Taiwan.
Trial summary
Among aesthetic or cosmetic surgeries, breast augmentation was the most frequently performed and the endoscopic transaxillary approach has become the preferred incision for Asian women. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Breast Augmentation, Inhalation Anesthesia, Total Intravenous Anesthesia
- What is being tested?
- Desflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jul 2017to 31 May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are appropriate for undergoing transaxillary endoscopic breast augmentation
- Age between 20-65 years
- Physical Status I or II as defined by the American Society of Anesthesiologists (ASA) Physical Status Classification System
Who cannot join
- Having difficulty reading or hearing
- Diagnosed with addictive disorder
- Diagnosed with psychiatric disorder
- Physical Status III-VI as defined by the ASA Physical Status Classification System
- Presence of acute infection or inflammatory condition (e.g., fever).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chimay Plastic Surgery Clinic, Taipei
Among aesthetic or cosmetic surgeries, breast augmentation was the most frequently performed and the endoscopic transaxillary approach has become the preferred incision for Asian women. As breast augmentation must be performed under general anesthesia accompanied by its effects and potential complications, types of general anesthesia may affect the quality of recovery. Currently, the two most common techniques of general anesthesia are inhalation anesthesia (IH) and total intravenous anesthesia (TIVA). The effects of these types of general anesthesia on the quality of recovery have been investigated for numerous surgical procedures. However, no prior studies have analyzed different types of anesthesia used for performing transaxillary endoscopic breast augmentation. This prospective, parallel, randomized controlled study will evaluate the effects of inhalation anesthesia vs. total intravenous anesthesia on the quality of recovery in patients undergoing transaxillary endoscopic breast augmentation.
- Conditions
- Breast Augmentation, Inhalation Anesthesia, Total Intravenous Anesthesia, Quality of Recovery
- 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 by desflurane in an oxygen air mixture of 60/40%. If inadequate depth of anesthesia is observed, the end-expiratory concentration of desflurane would be increased.
PropofolDrug
Anesthesia is maintained by propofol 100-200 μg/kg/min. If inadequate depth of anesthesia is observed, the rate of propofol infusion would be increased.
| Study group | Role | What they receive |
|---|---|---|
| IH group | Experimental | Inhalation anesthesia will be given during transaxillary endoscopic breast augmentation. Receives: Drug: Desflurane |
| TIVA group | Active comparator | Total intravenous anesthesia will be given during transaxillary endoscopic breast augmentation. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery, postoperative day one
Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.
Measured: On the 1st postoperative day
Quality of recovery, postoperative day two
Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.
Measured: On the 2nd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start28 Jul 2017
- Primary completion30 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chih-Cheng Hung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chih-Cheng Hung, Chimay Plastic Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036487
- Sponsor's protocol ID
- CMTMU201701
- Status last verified
- Aug 2019
- First submitted
- 25 Jul 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chimay Plastic Surgery Clinic, Taipei
- ClinicalTrials.gov ID
- NCT04036487
- Acronym / sponsor ID
- CMTMU201701
- Conditions
- Breast Augmentation, Inhalation Anesthesia, Total Intravenous Anesthesia, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chih-Cheng HungUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 29 Jul 2019 (actual)
- 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.
Among aesthetic or cosmetic surgeries, breast augmentation was the most frequently performed and the endoscopic transaxillary approach has become the preferred incision for Asian women. As breast augmentation must be performed under general anesthesia accompanied by its effects and potential complications, types of general anesthesia may affect the quality of recovery. Currently, the two most common techniques of general anesthesia are inhalation anesthesia (IH) and total intravenous anesthesia (TIVA). The effects of these types of general anesthesia on the quality of recovery have been investigated for numerous surgical procedures. However, no prior studies have analyzed different types of anesthesia used for performing transaxillary endoscopic breast augmentation. This prospective, parallel, randomized controlled study will evaluate the effects of inhalation anesthesia vs. total intravenous anesthesia on the quality of recovery in patients undergoing transaxillary endoscopic breast augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IH group | Experimental | Drug: DesfluraneInhalation anesthesia will be given during transaxillary endoscopic breast augmentation. |
| TIVA group | Active comparator | Drug: PropofolTotal intravenous anesthesia will be given during transaxillary endoscopic breast augmentation. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are appropriate for undergoing transaxillary endoscopic breast augmentation
- Age between 20-65 years
- Physical Status I or II as defined by the American Society of Anesthesiologists (ASA) Physical Status Classification System
Key exclusion criteria (5 listed)
- Having difficulty reading or hearing
- Diagnosed with addictive disorder
- Diagnosed with psychiatric disorder
- Physical Status III-VI as defined by the ASA Physical Status Classification System
- Presence of acute infection or inflammatory condition (e.g., fever).
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 by desflurane in an oxygen air mixture of 60/40%. If inadequate depth of anesthesia is observed, the end-expiratory concentration of desflurane would be increased. | Drug | IH group |
| PropofolAnesthesia is maintained by propofol 100-200 μg/kg/min. If inadequate depth of anesthesia is observed, the rate of propofol infusion would be increased. | Drug | TIVA group |
Primary outcome
Quality of recovery, postoperative day one
Time frame: On the 1st postoperative day
Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.
Quality of recovery, postoperative day two
Time frame: On the 2nd postoperative day
Quality of recovery is assessed by the 15-item Quality of Recovery (QoR-15) questionnaire. The total score of the 15-item QoR ranges from 0 to 150, and a higher score indicates a better outcome.
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 12 Aug 2019.
- 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 Desflurane and Propofol in people with Breast Augmentation and Inhalation Anesthesia, run by Chih-Cheng Hung at 1 site in Taiwan.
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 3 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 12 Aug 2019. 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 Taiwan. 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?
Quality of recovery, postoperative day one (time frame: On the 1st postoperative day). The study lists 2 primary outcomes in all. 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 12 Aug 2019.