DesfluraneNCT04805775
Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery
A study testing Desflurane Inhalation in people with Desflurane and Propofol, run by Zhongnan Hospital at 1 site in China.
Trial summary
This study intends to investigate the effects of desflurane on postoperative sleep quality to guide perioperative patient management. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Desflurane, Propofol, Postoperative Sleep
- What is being tested?
- Desflurane Inhalation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2021to 10 Mar 2023
- 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 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing elective breast surgery
- Age 18-75 years old
- ASA-PS grade I or II
- Those who voluntarily participate in the research and sign the informed consent
Who cannot join
- Cognitive impairment (MMSE <27) before the operation
- The patients received adjuvant chemotherapy before the operation
- At present, they are taking psychoactive, opioid, anti-anxiety, and hypnotic drugs
- Known or treated patients with obstructive sleep apnea
- Patients with other cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Desflurane on Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery: A Non-inferiority Randomized Controlled Trial
This study intends to investigate the effects of desflurane on postoperative sleep quality to guide perioperative patient management.
- Conditions
- Desflurane, Propofol, Postoperative Sleep, PSQI, Breast Tumor
- Being tested
- Desflurane Inhalation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desflurane InhalationDrug
Subjects were randomized in a 1:1 ratio to undergo breast surgery under maintenance of anesthesia with the classical intravenous anesthetic drug propofol (reference group) or the inhaled anesthetic drug desflurane (test group).
| Study group | Role | What they receive |
|---|---|---|
| Desflurane Inhalation Group | Experimental | Anesthesia maintenance: Desflurane inhalation (MAC 1.0-1.2) Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min) Receives: Drug: Desflurane Inhalation |
| Propofol Group | Active comparator | Anesthesia maintenance: Propofol TCI: 3-4ug / ml Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min) Receives: Drug: Desflurane Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index
Measured: Postoperative 3rd day
Secondary outcomes (7)
Pittsburgh sleep quality index
Measured: Postoperative 7th, and 30th days
Total sleep time (TST), Rapid eye movement time (REM), Wakefulness after sleep onset (WASO)
Fitbit Charge 2™ objectively measured
Measured: Postoperative 1st, 2nd, and 3rd days
Self-Rating Anxiety Scale Scores
Measured: Postoperative 3rd, 7th, and 30th days
Self-Rating Depression Scale Scores
Measured: Postoperative 3rd, 7th and 30th days
Visual analogue scale scores
Measured: Postoperative 3rd, 7th and 30th days
Flurbiprofen dose
Measured: Postoperative 1st, 2nd, and 3rd days
Recovery time and quality (steward scores)
Measured: Up to 2 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start21 Oct 2021
- Primary completion9 Sep 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DesfluraneStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805775
- Sponsor's protocol ID
- B076201420067
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Xiong B, Wu T, Liu X, Li K, Wang S, Deng MG, Peng M. Effect of desflurane maintenance on postoperative sleep quality in patients undergoing elective breast surgery: A non-inferiority randomized controlled trial. Sleep Med. 2024 Sep;121:287-294. doi: 10.1016/j.sleep.2024.07.022. Epub 2024 Jul 17.
PubMed 39038404
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Desflurane on Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery: A Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04805775
- Acronym / sponsor ID
- B076201420067
- Conditions
- Desflurane, Propofol, Postoperative Sleep, PSQI, Breast Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 18 Mar 2021 (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.
This study intends to investigate the effects of desflurane on postoperative sleep quality to guide perioperative patient management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane Inhalation Group | Experimental | Drug: Desflurane InhalationAnesthesia maintenance: Desflurane inhalation (MAC 1.0-1.2) Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min) |
| Propofol Group | Active comparator | Drug: Desflurane InhalationAnesthesia maintenance: Propofol TCI: 3-4ug / ml Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing elective breast surgery
- Age 18-75 years old
- ASA-PS grade I or II
- Those who voluntarily participate in the research and sign the informed consent
Key exclusion criteria (5 listed)
- Cognitive impairment (MMSE <27) before the operation
- The patients received adjuvant chemotherapy before the operation
- At present, they are taking psychoactive, opioid, anti-anxiety, and hypnotic drugs
- Known or treated patients with obstructive sleep apnea
- Patients with other cancers
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 |
|---|---|---|
| Desflurane InhalationSubjects were randomized in a 1:1 ratio to undergo breast surgery under maintenance of anesthesia with the classical intravenous anesthetic drug propofol (reference group) or the inhaled anesthetic drug desflurane (test group). | Drug | Desflurane Inhalation Group, Propofol Group |
Primary outcome
Pittsburgh sleep quality index
Time frame: Postoperative 3rd day
7 secondary outcomes
Pittsburgh sleep quality index
Time frame: Postoperative 7th, and 30th days
Total sleep time (TST), Rapid eye movement time (REM), Wakefulness after sleep onset (WASO)
Time frame: Postoperative 1st, 2nd, and 3rd days
Self-Rating Anxiety Scale Scores
Time frame: Postoperative 3rd, 7th, and 30th days
Self-Rating Depression Scale Scores
Time frame: Postoperative 3rd, 7th and 30th days
Visual analogue scale scores
Time frame: Postoperative 3rd, 7th and 30th days
Flurbiprofen dose
Time frame: Postoperative 1st, 2nd, and 3rd days
Recovery time and quality (steward scores)
Time frame: Up to 2 hours after operation
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 31 May 2023.
- Derived from this study: PubMed 39038404Wang X, Xiong B, Wu T, Liu X, Li K, Wang S, Deng MG, Peng M. Effect of desflurane maintenance on postoperative sleep quality in patients undergoing elective breast surgery: A non-inferiority randomized controlled trial. Sleep Med. 2024 Sep;121:287-294. doi: 10.1016/j.sleep.2024.07.022. Epub 2024 Jul 17.
- 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 Inhalation in people with Desflurane and Propofol, run by Zhongnan Hospital at 1 site in China.
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 4 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 31 May 2023. 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 China. 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?
Pittsburgh sleep quality index (time frame: Postoperative 3rd day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805775, which also lists 1 linked publication.
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 31 May 2023.