Gynecological Day SurgeryPhase 4NCT07094945
The Effect of Remimazolam on Postoperative Sleep Quality
A Phase 4 study testing Remimazolam and Propofol in people with Gynecological Day Surgery, run by Tongji Hospital.
Trial summary
A large amount of clinical evidence shows that after surgery, especially major surgery, the sleep quality of patients often drops significantly immediately, with the most obvious decline on the first night after surgery, which can last for several days to several months. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Gynecological Day Surgery
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 30 Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA classification grades I - II.
- BMI: 18.5-24 kg/m ².
- Be able to correctly understand and complete the assessment scale independently.
- The operation time shall not exceed one hour.
- Informed consent for this research.
Who cannot join
- PSQI > 7 points (with sleep disorders requiring medical intervention within the last month).
- Suffering from central nervous system diseases or mental disorders.
- Patients with sleep apnea syndrome or other serious respiratory diseases.
- Have functional disorders of important organs.
- Alcohol abuse or a history of opioid, benzodiazepine or other known drug abuse that may affect sleep.
- Allergic to the research medication.
About this study
Official title: The Effect of Remimazolam on Postoperative Sleep Quality of Patients Undergoing Gynecological Day Surgery
A large amount of clinical evidence shows that after surgery, especially major surgery, the sleep quality of patients often drops significantly immediately, with the most obvious decline on the first night after surgery, which can last for several days to several months. Remimazolam is a new type of benzodiazepine drug and a super-short-acting GABAA receptor agonist. Compared with propofol, remimazolam can largely avoid adverse reactions such as hemodynamic fluctuations, excessive sedation and injection pain caused by propofol. It has good safety and is superior to propofol. However, there are currently only a few clinical research results regarding the impact of remimazolam on the sleep quality of patients under general anesthesia or sedation. Therefore, this study intends to observe the effect of remimazolam on the sleep quality of patients in gynecological day surgery. It is expected that by optimizing the anesthesia plan, the postoperative sleep quality of patients can be improved, and ultimately the postoperative recovery of patients can be promoted.
- Conditions
- Gynecological Day Surgery
- Being tested
- Remimazolam, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam 0.3 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 0.6-1.0 mg/kg·h is used for anesthesia maintenance.
PropofolDrug
Propofol 2 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 4-12 mg/kg·h is used for anesthesia maintenance
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Grop | Experimental | Remimazolam 0.3mg/kg for induction and 0.6-1.0 mg/kg·h for maintenance of anesthesia Receives: Drug: Remimazolam |
| Propofol Group | Active comparator | Propofol 2 mg/kg for induction and 4-12 mg/kg·h for maintenance of anesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richard Campbell's Sleep Scale score
Range: 0 points (optimal sleep) to 10 points (optimal sleep). Direction: The higher the score, the more severe the sleep problem
Measured: The night of the first to third postoperative day
Secondary outcomes (3)
Blood Pressure
Measured: Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed
Heart rate
Measured: Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed.
Postoperative adverse reactions
such as postoperative pain, nausea, vomiting, and fatigue.
Measured: 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological Day SurgeryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094945
- Sponsor's protocol ID
- 2025S076
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 31 Jul 2025
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remimazolam on Postoperative Sleep Quality of Patients Undergoing Gynecological Day Surgery
- ClinicalTrials.gov ID
- NCT07094945
- Acronym / sponsor ID
- 2025S076
- Conditions
- Gynecological Day Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 Jul 2025 (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.
A large amount of clinical evidence shows that after surgery, especially major surgery, the sleep quality of patients often drops significantly immediately, with the most obvious decline on the first night after surgery, which can last for several days to several months. Remimazolam is a new type of benzodiazepine drug and a super-short-acting GABAA receptor agonist. Compared with propofol, remimazolam can largely avoid adverse reactions such as hemodynamic fluctuations, excessive sedation and injection pain caused by propofol. It has good safety and is superior to propofol. However, there are currently only a few clinical research results regarding the impact of remimazolam on the sleep quality of patients under general anesthesia or sedation. Therefore, this study intends to observe the effect of remimazolam on the sleep quality of patients in gynecological day surgery. It is expected that by optimizing the anesthesia plan, the postoperative sleep quality of patients can be improved, and ultimately the postoperative recovery of patients can be promoted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Grop | Experimental | Drug: RemimazolamRemimazolam 0.3mg/kg for induction and 0.6-1.0 mg/kg·h for maintenance of anesthesia |
| Propofol Group | Active comparator | Drug: PropofolPropofol 2 mg/kg for induction and 4-12 mg/kg·h for maintenance of anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA classification grades I - II.
- BMI: 18.5-24 kg/m ².
- Be able to correctly understand and complete the assessment scale independently.
- The operation time shall not exceed one hour.
- Informed consent for this research.
Key exclusion criteria (6 listed)
- PSQI > 7 points (with sleep disorders requiring medical intervention within the last month).
- Suffering from central nervous system diseases or mental disorders.
- Patients with sleep apnea syndrome or other serious respiratory diseases.
- Have functional disorders of important organs.
- Alcohol abuse or a history of opioid, benzodiazepine or other known drug abuse that may affect sleep.
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 |
|---|---|---|
| RemimazolamRemimazolam 0.3 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 0.6-1.0 mg/kg·h is used for anesthesia maintenance. | Drug | Remimazolam Grop |
| PropofolPropofol 2 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 4-12 mg/kg·h is used for anesthesia maintenance | Drug | Propofol Group |
Primary outcome
Richard Campbell's Sleep Scale score
Time frame: The night of the first to third postoperative day
Range: 0 points (optimal sleep) to 10 points (optimal sleep). Direction: The higher the score, the more severe the sleep problem
3 secondary outcomes
Blood Pressure
Time frame: Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed
Heart rate
Time frame: Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed.
Postoperative adverse reactions
Time frame: 24 hours after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam and Propofol in people with Gynecological Day Surgery, run by Tongji Hospital.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 31 Jul 2025. 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
Richard Campbell's Sleep Scale score (time frame: The night of the first to third postoperative day). 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 31 Jul 2025.