Remimazolam Versus Propofol for Painless Abortion

Remimazolam Versus Propofol, in Combination With Esketamine for Painless Abortion

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 Overview

• Status: Completed
• Conditions: Anesthesia; Abortion Early
• Intervention / Treatment: Drug: Remimazolam; Drug: Esketamine; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Maternal and Child Health Hospital of Hubei Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Hubei Province
• Collaborators: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Na Li, MD, Maternal and Child Health Hospital of Hubei Province

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Propofol; Esketamine
• Other Study ID Numbers: MCHH_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No