NCT05635955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

November 15, 2022

Last Update Submit

November 22, 2022

Conditions

AnesthesiaAbortion Early

Outcome Measures

Primary Outcomes (1)

  • Time to loss of consciousness

    The time from the study drug administration to loss of consciousness

    5 - 30 minutes

Secondary Outcomes (6)

  • Success rate of sedation

    Intraoperative period, 30 minutes - 1.5 hours

  • Recovery time

    Postoperative 30 minutes

  • Mean arterial pressure (MAP)

    Intraoperative period, 30 minutes - 1.5 hours

  • Heart rate (HR)

    Intraoperative period, 30 minutes - 1.5 hours

  • Adverse events

    Intraoperative and post-operation, 30 minutes - 1.5 hours

  • +1 more secondary outcomes

Study Arms (2)

Remimazolam

EXPERIMENTAL

Intravenous Remimazolam will be co-administrated with esketamine.

Drug: RemimazolamDrug: Esketamine

Propofol

ACTIVE COMPARATOR

Intravenous Propofol will be co-administrated with esketamine.

Drug: PropofolDrug: Esketamine

Interventions

RemimazolamDRUG

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.

Remimazolam
PropofolDRUG

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.

Propofol
EsketamineDRUG

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

PropofolRemimazolam

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • chronic pain
  • psychiatric disorders
  • liver or kidney failure
  • severe metabolic disorders
  • poor respiratory functions
  • cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Interventions

remimazolamPropofolEsketamine

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Na Li, MD

    Maternal and Child Health Hospital of Hubei Province

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief Physician

Study Record Dates

First Submitted

November 15, 2022

First Posted

December 2, 2022

Study Start

August 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations

CN(1)