Remimazolam Versus Propofol for Painless Abortion

Maternal and Child Health Hospital of Hubei Province

Status and phase: Completed; Phase 2

Conditions: Abortion Early; Anesthesia

Treatments: Drug: Propofol; Drug: Remimazolam; Drug: Esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05635955

MCHH_001

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Remimazolam

Experimental group

Description:

Intravenous Remimazolam will be co-administrated with esketamine.

Treatment:

Drug: Remimazolam

Drug: Esketamine

Propofol

Active Comparator group

Description:

Intravenous Propofol will be co-administrated with esketamine.

Treatment:

Drug: Propofol

Drug: Esketamine