Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2022-08-01
2022-09-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Remimazolam
Intravenous Remimazolam will be co-administrated with esketamine.
Remimazolam
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.
Esketamine
0.3mg/kg esketamine will be co-administrated in both arms
Propofol
Intravenous Propofol will be co-administrated with esketamine.
Propofol
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.
Esketamine
0.3mg/kg esketamine will be co-administrated in both arms
Interventions
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Remimazolam
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.
Propofol
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.
Esketamine
0.3mg/kg esketamine will be co-administrated in both arms
Eligibility Criteria
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Inclusion Criteria
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* competent to provide informed consent
Exclusion Criteria
* psychiatric disorders
* liver or kidney failure
* severe metabolic disorders
* poor respiratory functions
* cardiovascular diseases
18 Years
65 Years
FEMALE
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Maternal and Child Health Hospital of Hubei Province
OTHER
Responsible Party
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Li Na
Deputy Chief Physician
Principal Investigators
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Na Li, MD
Role: PRINCIPAL_INVESTIGATOR
Maternal and Child Health Hospital of Hubei Province
Locations
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Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China
Countries
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Other Identifiers
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MCHH_001
Identifier Type: -
Identifier Source: org_study_id
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