Postoperative Sleep QualityPhase 4NCT02146976
Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy
A Phase 4 study testing propofol and sevoflurane in people with Postoperative Sleep Quality, run by China Medical University, China at 1 site in China.
Trial summary
The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Sleep Quality
- What is being tested?
- propofol and sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2015
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were deemed eligible if they were candidates for general anesthesia undergoing thyroidectomy
Who cannot join
- Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a Pittsburgh Sleep Quality Index global scores higher than 6, had an anesthesia time longer than 4 hours, had a history of cardiovascular, neurological, or psychiatric disease, had cervical lymph node metastasis, were treated with sedative and analgesics during the postoperative BIS-Vista monitoring period, were allergic to drugs used in the study, or had been diagnosed with Graves' disease or hyperthyroidism or hypothyroidism.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.
Read the detailed description
The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.The bispectral index score (BIS) was monitored during the operation and the first postoperative night.
- Conditions
- Postoperative Sleep Quality
- Being tested
- propofol, sevoflurane
- Keywords
- postoperative, sleep quality, propofol, sevoflurane
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
introvenious infusion of propofol
sevofluraneDrug
sevoflurane (1.0-1.3 Minimum Alveolar Concentration)
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | introvenious infusion of propofol Receives: Drug: propofol |
| Inhaled anaesthetic (Sevoflurane) | Experimental | sevoflurane (1.0-1.3% Minimum Alveolar Concentration) Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of postoperative sleep quality
The primary outcome was the postoperative sleep quality, which was measured by the BIS-Vista monitor on the first night after surgery.
Measured: preoperation, first postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sleep QualityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
- Investigators
- Hong Ma, M.D.,Ph.D., Study chair, the Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146976
- Sponsor's protocol ID
- 20140522
- Status last verified
- Nov 2015
- First submitted
- 22 May 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy
- ClinicalTrials.gov ID
- NCT02146976
- Acronym / sponsor ID
- 20140522
- Conditions
- Postoperative Sleep Quality
- Keywords
- postoperative, sleep quality, propofol, sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 May 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.
The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.
Detailed description
The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.The bispectral index score (BIS) was monitored during the operation and the first postoperative night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: propofolintrovenious infusion of propofol |
| Inhaled anaesthetic (Sevoflurane) | Experimental | Drug: sevofluranesevoflurane (1.0-1.3% Minimum Alveolar Concentration) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants were deemed eligible if they were candidates for general anesthesia undergoing thyroidectomy
Key exclusion criteria (1 listed)
- Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a Pittsburgh Sleep Quality Index global scores higher than 6, had an anesthesia time longer than 4 hours, had a history of cardiovascular, neurological, or psychiatric disease, had cervical lymph node metastasis, were treated with sedative and analgesics during the postoperative BIS-Vista monitoring period, were allergic to drugs used in the study, or had been diagnosed with Graves' disease or hyperthyroidism or hypothyroidism.
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 |
|---|---|---|
| propofolintrovenious infusion of propofol | Drug | Propofol |
| sevofluranesevoflurane (1.0-1.3 Minimum Alveolar Concentration) | Drug | Inhaled anaesthetic (Sevoflurane) |
Primary outcome
The Change of postoperative sleep quality
Time frame: preoperation, first postoperative night
The primary outcome was the postoperative sleep quality, which was measured by the BIS-Vista monitor on the first night 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 29 Jan 2016.
- Individual participant dataSharing planned: Undecided
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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.
Hong Ma, M.D.,Ph.D. study chair
the Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol and sevoflurane in people with Postoperative Sleep Quality, run by China Medical University, China 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 1 inclusion and 1 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 29 Jan 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Change of postoperative sleep quality (time frame: preoperation, first postoperative night). 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 29 Jan 2016.