Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia

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Capital Medical University

Status

Enrolling

Conditions

Post-anesthesia Recovery

Treatments

Drug: Saline
Drug: Esketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT06430645
esketamine_2024

Details and patient eligibility

About

Esketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor different from other gamma-aminobutyric acid (GABA) receptor agonists. Recent studies showed that subanesthetic doses of ketamine not only deepen anesthesia but also accelerate recovery from isoflurane anesthesia in mice. It is necessary to verify if it applies to human. Besides inducing behavioral unresponsiveness, an optimal and important goal of general anesthesia is to prevent connected consciousness. The results of many studies support the conclusion that anesthesia-related unconsciousness is a consistent functional disconnection of lateral frontoparietal networks.The goal of this clinical trial is to learn if subanaesthetic doses of esketamine works to accelerate the recovery of consciousness from propofol anesthesia. It will also learn about the change of brain network when administrated the esketamine during propofol anesthesia. The main questions it aims to answer are: 1. Does subanaesthetic doses of esketamine can accelerate recovery from propofol anaesthesia? 2. What will happen to brain network connection after different doses of esketamine during propofol anesthesia?

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged from 18 years to 50 years
  • Patients scheduled for elective operative hysteroscopy
  • Willing to sign informed consent

Exclusion criteria

  • Contraindications of propofol and esketamine
  • Contraindications for EEG;
  • ASA≥III;
  • BMI≥30 kg/m2 or BMI<18 kg/m2;
  • The MMSE scale score is lower than the normal value;
  • Alcohol or drug abuse;
  • Untreated or under-treated hypertension, hyperthyroidism, risk of increased intracranial pressure, audio-visual impairment, history of psychiatric disorders or neurological diseases, malignant tumors or other major diseases;
  • Use of other neurological drugs or drugs known to interact with propofol and esketamine in the past 2 weeks;
  • Pregnant and lactating women;
  • The operation duration is shorter than 15 minutes or longer than 60 minutes.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 3 patient groups

low dose of esketamine
Experimental group
Description:
Drug:esketamine (0.3mg/kg)
Treatment:
Drug: Esketamine
Drug: Esketamine
high dose of esketamine
Experimental group
Description:
Drug:esketamine(0.6mg/kg)
Treatment:
Drug: Esketamine
Drug: Esketamine
control group
Experimental group
Description:
Drug:0.9% saline
Treatment:
Drug: Saline

Trial contacts and locations

1

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Central trial contact

Yang Li, Master

Data sourced from clinicaltrials.gov

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