Remimazolam Versus Propofol for Painless Abortion
- Conditions
- AnesthesiaAbortion Early
- Interventions
- Registration Number
- NCT05635955
- Lead Sponsor
- Maternal and Child Health Hospital of Hubei Province
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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
- chronic pain
- psychiatric disorders
- liver or kidney failure
- severe metabolic disorders
- poor respiratory functions
- cardiovascular diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol Esketamine Intravenous Propofol will be co-administrated with esketamine. Remimazolam Esketamine Intravenous Remimazolam will be co-administrated with esketamine. Remimazolam Remimazolam Intravenous Remimazolam will be co-administrated with esketamine. Propofol Propofol Intravenous Propofol will be co-administrated with esketamine.
- Primary Outcome Measures
Name Time Method Time to loss of consciousness 5 - 30 minutes The time from the study drug administration to loss of consciousness
- Secondary Outcome Measures
Name Time Method Success rate of sedation Intraoperative period, 30 minutes - 1.5 hours Defined as completing the induction of anesthesia without an additional dosage
Recovery time Postoperative 30 minutes 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.
Mean arterial pressure (MAP) Intraoperative period, 30 minutes - 1.5 hours 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).
Heart rate (HR) Intraoperative period, 30 minutes - 1.5 hours 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).
Adverse events Intraoperative and post-operation, 30 minutes - 1.5 hours 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.
Post-operative pain Post-operation after fully awake, 30 minutes - 1 hour 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').
Trial Locations
- Locations (1)
Maternal and Child Health Hospital of Hubei Province
🇨🇳Wuhan, Hubei, China