Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esketamine, Esketamine, Saline.
- Who it may be relevant to
- Registry conditions: Post-anesthesia Recovery. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Interventions
- Drug Esketamine
Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). Esketamine hydrochloride (0.3mg/kg total body weight) single intravenous injection after stable plasma concentration of propofol deep sedation. - Drug Esketamine
Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). Esketamine hydrochloride (0.6mg/kg total body weight) single intravenous injection after stable plasma concentration of propofol deep sedation. - Drug Saline
Sufentanil(0.1ug/kg) and flurbiprofen axetil(50mg) are administered before induction. Propofol (10 mg/ml) is infused via target-controlled infusions (TCIs). The same volume of 0.9% saline instead of esketamine will be given to the control group after stable plasma concentration of propofol deep sedation.
Primary outcome measures
- Recovery time [Time frame: 2 hours]
Secondary outcome measures (7)
- Explicit memory scores and implicit memory scores [Time frame: 2 hours]
- Subjective experience report [Time frame: 2 hours]
- Grooved Pegboard Test points [Time frame: 2 hours]
- Patients state index [Time frame: 2 hours]
- Spectral edge frequency [Time frame: 2 hours]
- Burst suppression ratio [Time frame: 2 hours]
- Original EEG [Time frame: 2 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
China · 1 center
- Beijing Tiantan Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06430645 · esketamine_2024