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Completed

NCT Number: NCT05635955

Remimazolam Versus Propofol 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.

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Key information

Conditions

Anesthesia Abortion Early

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. Time to loss of consciousness

    Time frame: 5 - 30 minutes

    The time from the study drug administration to loss of consciousness

Secondary outcomes

  1. Success rate of sedation

    Time frame: Intraoperative period, 30 minutes - 1.5 hours

    Defined as completing the induction of anesthesia without an additional dosage

  2. Recovery time

    Time frame: 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.

  3. Mean arterial pressure (MAP)

    Time frame: 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).

  4. Heart rate (HR)

    Time frame: 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).

  5. Adverse events

    Time frame: 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.

  6. Post-operative pain

    Time frame: 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').

Sponsors and collaborators

Lead sponsor

Maternal and Child Health Hospital of Hubei Province

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Official study title

Remimazolam Versus Propofol, in Combination With Esketamine for Painless Abortion

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2022
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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