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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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.
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.
0.3mg/kg esketamine will be co-administrated in both arms
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China
Time to loss of consciousness
The time from the study drug administration to loss of consciousness
Time frame: 5 - 30 minutes
Success rate of sedation
Defined as completing the induction of anesthesia without an additional dosage
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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').
Time frame: Post-operation after fully awake, 30 minutes - 1 hour
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