Abortion Early, Anesthesia
Conditions
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.
Interventions
DRUGRemimazolam
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.
DRUGPropofol
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.
DRUGEsketamine
0.3mg/kg esketamine will be co-administrated in both arms
Sponsors
The Hong Kong Polytechnic University
Maternal and Child Health Hospital of Hubei Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* chronic pain * psychiatric disorders * liver or kidney failure * severe metabolic disorders * poor respiratory functions * cardiovascular diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to loss of consciousness | 5 - 30 minutes | The time from the study drug administration to loss of consciousness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Success rate of sedation | Intraoperative period, 30 minutes - 1.5 hours | Defined as completing the induction of anesthesia without an additional dosage |
| 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'). |
| 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). |
Countries
China
Outcome results
None listed