AnesthesiaPhase 2NCT05635955
Remimazolam Versus Propofol for Painless Abortion
A Phase 2 study testing Remimazolam, Propofol and Esketamine in people with Anesthesia and Abortion Early, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety of propofol vs. remimazolam in combine use of esketamine in women with early pregnancy undergoing painless abortion. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia, Abortion Early
- What is being tested?
- Remimazolam, Propofol and Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 30 Sep 2022
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- early intrauterine pregnancy less than 12 weeks confirmed by transabdominal ultrasound and blood HCG
- the American Society of Anesthesiologists (ASA) physical status ranked I-II
- competent to provide informed consent
Who cannot join
- chronic pain
- psychiatric disorders
- liver or kidney failure
- severe metabolic disorders
- poor respiratory functions
- cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430000
About this study
Official title: Remimazolam Versus Propofol, in Combination With Esketamine for Painless Abortion
The goal of this clinical trial is to compare the efficacy and safety of propofol vs. remimazolam in combine use of esketamine in women with early pregnancy undergoing painless abortion. The main questions it aims to answer are:
- whether remimazolam plus esketamine (R+E) has a better sedative and analgesic effectiveness than propofol plus esketamine (P+E).
- whether R+E has less adverse events than P+E.
Read more
Participants will be randomly allocated to two groups: R+E and P+E group.
- For those in group R+E: they will be administered with 0.3mg/kg remimazolam and 0.3mg/kg esketamine before the abortion surgery.
- For those in group P+E: they will be administered with 2mg/kg propofol and 0.3mg/kg esketamine before the abortion surgery.
We will compare R+E with P+E to see if the time to loss of conscious and time to recover from the sedation will be shorter and if there will be less severe adverse events in R+E.
- Conditions
- Anesthesia, Abortion Early
- Being tested
- Remimazolam, Propofol, Esketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Total intravenous anaesthesia will be induced with 0.3mg/kg remimazolam and 0.3mg/kg esketamine, slow injection.
During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.2 mg/kg remimazolam (IV) will be administrated.
PropofolDrug
Total intravenous anaesthesia will be induced with 2mg/kg propofol and 0.3mg/kg esketamine, slow injection.
During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.25 mg/kg propofol (IV) will be administrated.
EsketamineDrug
0.3mg/kg esketamine will be co-administrated in both arms
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Intravenous Remimazolam will be co-administrated with esketamine. Receives: Drug: Remimazolam; Drug: Esketamine |
| Propofol | Active comparator | Intravenous Propofol will be co-administrated with esketamine. Receives: Drug: Propofol; Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to loss of consciousness
The time from the study drug administration to loss of consciousness
Measured: 5 - 30 minutes
Secondary outcomes (6)
Success rate of sedation
Defined as completing the induction of anesthesia without an additional dosage
Measured: Intraoperative period, 30 minutes - 1.5 hours
Recovery time
Time to fully awake, defined as by a modified Aldrete score which will be recorded every 3 minutes from the end of the procedure with a recovery index (MAS) of 9 or more.
Measured: Postoperative 30 minutes
Mean arterial pressure (MAP)
MAP level will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), in sedation when vaginal dilator is placed (Time 1), in sedation when curettage begins (Time 2), and postoperative awakening (Time 3).
Measured: Intraoperative period, 30 minutes - 1.5 hours
Heart rate (HR)
HR will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), in sedation when vaginal dilator is placed (Time 1), in sedation when curettage begins (Time 2), and postoperative awakening (Time 3).
Measured: Intraoperative period, 30 minutes - 1.5 hours
Adverse events
The adverse events will be monitored and recorded during the operation and post-operation. AE will include: respiratory depression (defined as SpO2< 95%), hypotension (defined as systolic arterial pressure < 80 mmHg, or decreased baseline systolic blood pressure > 20%), hypertension, bradycardia (defined as decrease in HR < 50/min), number of body movements, injection site pain and nausea and vomiting.
Measured: Intraoperative and post-operation, 30 minutes - 1.5 hours
Post-operative pain
It will be assessed by Visual Analogue Scale (VAS) pain score. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Post-operation after fully awake, 30 minutes - 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Aug 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Li Na, Maternal and Child Health Hospital of Hubei Province
- Investigators
- Na Li, MD, Principal investigator, Maternal and Child Health Hospital of Hubei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635955
- Sponsor's protocol ID
- MCHH_001
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 2 Dec 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam Versus Propofol, in Combination With Esketamine for Painless Abortion
- ClinicalTrials.gov ID
- NCT05635955
- Acronym / sponsor ID
- MCHH_001
- Conditions
- Anesthesia, Abortion Early
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 2 Dec 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.
The goal of this clinical trial is to compare the efficacy and safety of propofol vs. remimazolam in combine use of esketamine in women with early pregnancy undergoing painless abortion. The main questions it aims to answer are:
- whether remimazolam plus esketamine (R+E) has a better sedative and analgesic effectiveness than propofol plus esketamine (P+E).
- whether R+E has less adverse events than P+E.
Participants will be randomly allocated to two groups: R+E and P+E group.
- For those in group R+E: they will be administered with 0.3mg/kg remimazolam and 0.3mg/kg esketamine before the abortion surgery.
- For those in group P+E: they will be administered with 2mg/kg propofol and 0.3mg/kg esketamine before the abortion surgery.
We will compare R+E with P+E to see if the time to loss of conscious and time to recover from the sedation will be shorter and if there will be less severe adverse events in R+E.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam, Drug: EsketamineIntravenous Remimazolam will be co-administrated with esketamine. |
| Propofol | Active comparator | Drug: Propofol, Drug: EsketamineIntravenous Propofol will be co-administrated with esketamine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- early intrauterine pregnancy less than 12 weeks confirmed by transabdominal ultrasound and blood HCG
- the American Society of Anesthesiologists (ASA) physical status ranked I-II
- competent to provide informed consent
Key exclusion criteria (6 listed)
- chronic pain
- psychiatric disorders
- liver or kidney failure
- severe metabolic disorders
- poor respiratory functions
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 |
|---|---|---|
| RemimazolamTotal intravenous anaesthesia will be induced with 0.3mg/kg remimazolam and 0.3mg/kg esketamine, slow injection. During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.2 mg/kg remimazolam (IV) will be administrated. | Drug | Remimazolam |
| PropofolTotal intravenous anaesthesia will be induced with 2mg/kg propofol and 0.3mg/kg esketamine, slow injection. During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.25 mg/kg propofol (IV) will be administrated. | Drug | Propofol |
| Esketamine0.3mg/kg esketamine will be co-administrated in both arms | Drug | Propofol, Remimazolam |
Primary outcome
Time to loss of consciousness
Time frame: 5 - 30 minutes
The time from the study drug administration to loss of consciousness
6 secondary outcomes
Success rate of sedation
Time frame: Intraoperative period, 30 minutes - 1.5 hours
Recovery time
Time frame: Postoperative 30 minutes
Mean arterial pressure (MAP)
Time frame: Intraoperative period, 30 minutes - 1.5 hours
Heart rate (HR)
Time frame: Intraoperative period, 30 minutes - 1.5 hours
Adverse events
Time frame: Intraoperative and post-operation, 30 minutes - 1.5 hours
Post-operative pain
Time frame: Post-operation after fully awake, 30 minutes - 1 hour
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 2 Dec 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.
Na Li, MD principal investigator
Maternal and Child Health Hospital of Hubei Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remimazolam, Propofol and Esketamine in people with Anesthesia and Abortion Early, run by Maternal and Child Health Hospital of Hubei Province 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 3 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: finished, as of the sponsor's last update on 2 Dec 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to loss of consciousness (time frame: 5 - 30 minutes). 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 2 Dec 2022.