Remimazolam Versus Propofol for Painless Abortion

Anesthesia Clinical Trial

Official title:

Remimazolam Versus Propofol, in Combination With Esketamine for Painless Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05635955
• Other study ID #: MCHH_001
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Maternal and Child Health Hospital of Hubei Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion Early
• Anesthesia

Intervention

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.
• 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.
• Esketamine
0.3mg/kg esketamine will be co-administrated in both arms

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Hubei Province	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Maternal and Child Health Hospital of Hubei Province	The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to loss of consciousness	The time from the study drug administration to loss of consciousness	5 - 30 minutes
Secondary	Success rate of sedation	Defined as completing the induction of anesthesia without an additional dosage	Intraoperative period, 30 minutes - 1.5 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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