Remimazolam Versus Propofol for Painless Abortion

Study Overview
=================
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.

Official Title
-----------------
Remimazolam Versus Propofol, in Combination With Esketamine for Painless Abortion

Conditions
-----------------
Anesthesia, Abortion Early

Intervention / Treatment
-----------------
* Drug: Remimazolam
* Drug: Propofol
* Drug: Esketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br>Intravenous Remimazolam will be co-administrated with esketamine. | Drug: Remimazolam<br>* 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.<br>Drug: Esketamine<br>* 0.3mg/kg esketamine will be co-administrated in both arms<br>|
| Active Comparator: Propofol<br>Intravenous Propofol will be co-administrated with esketamine. | Drug: Propofol<br>* 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.<br>Drug: Esketamine<br>* 0.3mg/kg esketamine will be co-administrated in both arms<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to loss of consciousness | The time from the study drug administration to loss of consciousness | 5 - 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of sedation | Defined as completing the induction of anesthesia without an additional dosage | 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. | 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). | 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). | 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. | 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'). | Post-operation after fully awake, 30 minutes - 1 hour |