Sleep DisorderPhase 4NCT05325762
Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders
A Phase 4 study testing Propofol, Dexmedetomidine and Saline in people with Sleep Disorder, run by Xiangya Hospital of Central South University at 4 sites in China.
Trial summary
This study intends to conduct postoperative sleep intervention for elderly patients with sleep disorders undergoing surgery. We hope to explore whether propofol can improve the postoperative sleep quality of elderly patients with sleep disorders, prevent the occurrence of postoperative delirium in elderly patients… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Propofol, Dexmedetomidine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 4 sitesChina
- Study dates
- 1 Dec 2022to 25 Dec 2023
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 60 years old
- Chronic insomnia
- Pittsburgh Sleep Quality Index>5 points
- Daytime functional impairment (component Ⅶ ≥2 points in PSQI)
- Patients undergoing elective surgery
- Patients to be admitted to ICU after surgery
- Voluntarily participate in the study and sign the informed consent
Who cannot join
- Subjects with severe hemodynamic instability
- Subjects with difficult airway
- Patients with other sleep disorders (including sleep apnea syndrome, exercise-related sleep disorders and other types of sleep disorders)
- Subjects requiring sedation, mechanical ventilation, or sleep prior to medication;
- Severe liver dysfunction (Child-Pugh GRADE C)
- Severe renal dysfunction (requiring dialysis before surgery)
- Patients with allergies to study drugs and related ingredients
- Patients with severe dementia, low cognitive function, language impairment, severe hearing or vision impairment, mental disorder, coma and other conditions cannot complete the assessment
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders: a Multicentre, Randomized, Controlled Clinical Study
This study intends to conduct postoperative sleep intervention for elderly patients with sleep disorders undergoing surgery. We hope to explore whether propofol can improve the postoperative sleep quality of elderly patients with sleep disorders, prevent the occurrence of postoperative delirium in elderly patients, relieve patients' pain, promote patients' postoperative rehabilitation, and provide reference for realizing the rapid rehabilitation of elderly patients with sleep disorders through intravenous administration of research drugs, on the premise of improving patient comfort and ensuring patient safety.
Read the detailed description
The purpose of this multicenter, randomized, controlled clinical study was to evaluate the efficacy and safety of propofol compared with normal saline and dexmedetomidine in the effect of postoperative sleep quality in elderly subjects with sleep disorders. Subjects were randomly assigned to propofol group, dexmedetomidine group or normal saline control group. Propofol group: At 21:00 on the night of tracheal extubation, propofol was administered intravenously. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration.Dexmedetomidine group: treated with dexmedetomidine at 21 PM on the day of tracheal extubation. During administration, patients were evaluated with MOAA/S every 2min. Normal saline control group: 21 on the night of tracheal extubation: Normal saline was injected intravenously at the rate of 0.5ml/(kg.h) beginning at 00. During the administration, patients were evaluated with MOAA/S every 2min. The effect of drugs on sleep improvement was evaluated by subjective scale and objective electrical monitoring.
- Conditions
- Sleep Disorder
- Being tested
- Propofol, Dexmedetomidine, Saline
- Keywords
- Sleep Disorder, Propofol, Dexmedetomidine
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
At 21:00 on the night of tracheal extubation, propofol was administered intravenously with a microinjection pump for 2min. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration.
DexmedetomidineDrug
Dexmedetomidine was at 21 PM on the day of tracheal extubation: Dexmedetomidine was injected intravenously beginning at 00. During administration, patients were evaluated with MOAA/S every 2min.
SalineDrug
At 21:00 PM on the day of tracheal extubation, normal saline was injected intravenously. During the administration, patients were evaluated with MOAA/S every 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Not described Receives: Drug: Propofol |
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep improvement efficiency
The total score of The Leeds Sleep Evaluation Questionaire was > 100 （The score ranges from 0 to 100， a higher scores mean a better outcome.）, the incubation period of sleep was < 30min, the sleep duration was > 5h, and the sleep quality was good. Assess changes at several points in time.
Measured: Preoperative, postoperative 1-7 days, postoperative 30 days
Secondary outcomes (2)
Safety of drug use
Adverse events and serious adverse events.
Measured: The first night after surgery
Sleep scale assessment
Preoperative and postoperative sleep was assessed using Pittsburgh sleep quality index. Assess changes at several points in time.
Measured: Preoperative, postoperative 1-7 days, postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Dec 2022 (estimated)
- Primary completion25 Oct 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were evaluated with MOAA/S by intravenous administration of propofol, dexmedetomidine, or normal saline until successful sleep (MOAA/S≤2)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325762
- Sponsor's protocol ID
- XiangyaH1
- Status last verified
- Feb 2022
- First submitted
- 27 Feb 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol on Postoperative Sleep Quality in Elderly Patients With Sleep Disorders: a Multicentre, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05325762
- Acronym / sponsor ID
- XiangyaH1
- Conditions
- Sleep Disorder
- Keywords
- Sleep Disorder, Propofol, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 25 Oct 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 13 Apr 2022 (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 conduct postoperative sleep intervention for elderly patients with sleep disorders undergoing surgery. We hope to explore whether propofol can improve the postoperative sleep quality of elderly patients with sleep disorders, prevent the occurrence of postoperative delirium in elderly patients, relieve patients' pain, promote patients' postoperative rehabilitation, and provide reference for realizing the rapid rehabilitation of elderly patients with sleep disorders through intravenous administration of research drugs, on the premise of improving patient comfort and ensuring patient safety.
Detailed description
The purpose of this multicenter, randomized, controlled clinical study was to evaluate the efficacy and safety of propofol compared with normal saline and dexmedetomidine in the effect of postoperative sleep quality in elderly subjects with sleep disorders. Subjects were randomly assigned to propofol group, dexmedetomidine group or normal saline control group. Propofol group: At 21:00 on the night of tracheal extubation, propofol was administered intravenously. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration.Dexmedetomidine group: treated with dexmedetomidine at 21 PM on the day of tracheal extubation. During administration, patients were evaluated with MOAA/S every 2min. Normal saline control group: 21 on the night of tracheal extubation: Normal saline was injected intravenously at the rate of 0.5ml/(kg.h) beginning at 00. During the administration, patients were evaluated with MOAA/S every 2min. The effect of drugs on sleep improvement was evaluated by subjective scale and objective electrical monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients were evaluated with MOAA/S by intravenous administration of propofol, dexmedetomidine, or normal saline until successful sleep (MOAA/S≤2)
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Propofol |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
| saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥ 60 years old
- Chronic insomnia
- Pittsburgh Sleep Quality Index>5 points
- Daytime functional impairment (component Ⅶ ≥2 points in PSQI)
- Patients undergoing elective surgery
Key exclusion criteria (8 listed)
- Subjects with severe hemodynamic instability
- Subjects with difficult airway
- Patients with other sleep disorders (including sleep apnea syndrome, exercise-related sleep disorders and other types of sleep disorders)
- Subjects requiring sedation, mechanical ventilation, or sleep prior to medication;
- Severe liver dysfunction (Child-Pugh GRADE C)
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 |
|---|---|---|
| PropofolAt 21:00 on the night of tracheal extubation, propofol was administered intravenously with a microinjection pump for 2min. MOAAS/S was used to evaluate subjects 30 seconds after the end of administration. | Drug | Propofol |
| DexmedetomidineDexmedetomidine was at 21 PM on the day of tracheal extubation: Dexmedetomidine was injected intravenously beginning at 00. During administration, patients were evaluated with MOAA/S every 2min. | Drug | Dexmedetomidine |
| SalineAt 21:00 PM on the day of tracheal extubation, normal saline was injected intravenously. During the administration, patients were evaluated with MOAA/S every 2 minutes. | Drug | saline |
Primary outcome
Sleep improvement efficiency
Time frame: Preoperative, postoperative 1-7 days, postoperative 30 days
The total score of The Leeds Sleep Evaluation Questionaire was > 100 （The score ranges from 0 to 100， a higher scores mean a better outcome.）, the incubation period of sleep was < 30min, the sleep duration was > 5h, and the sleep quality was good. Assess changes at several points in time.
2 secondary outcomes
Safety of drug use
Time frame: The first night after surgery
Sleep scale assessment
Time frame: Preoperative, postoperative 1-7 days, postoperative 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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.
4 sites 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, Dexmedetomidine and Saline in people with Sleep Disorder, run by Xiangya Hospital of Central South University at 4 sites 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact e wang, M.D. (18874889950 ext. +86, ewang324@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep improvement efficiency (time frame: Preoperative, postoperative 1-7 days, postoperative 30 days). 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 3 Oct 2022.