Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
Location status: Recruiting
Recruiting
NCT Number: NCT06430645
Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia
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?
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Esketamine
DrugSufentanil(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.
Saline
DrugSufentanil(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 outcomes
-
Recovery time
Time frame: 2 hours
Recovery time will be defined as the time from terminating propofol administration to opening eyes to verbal stimuli (participants addressed by name) or, if necessary, mild tactile stimuli (a tap in the shoulder) every 30 seconds.
Secondary outcomes
-
Explicit memory scores and implicit memory scores
Time frame: 2 hours
The task includes process-dissociation procedure with the word-stem completion. The value ranges from -1 to 1. If the value is less than or equal to 0, it means no memory. If the value is more than 0, it means memory is detected.
-
Subjective experience report
Time frame: 2 hours
The judges of structured interviews includes three main categories: reports of no recall of any experiences, white reports and reports with specific content.
-
Grooved Pegboard Test points
Time frame: 2 hours
Time to complete the Grooved Pegboard Test with dominant and non-dominant hand.
-
Patients state index
Time frame: 2 hours
Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). Patients state index (PSI) uses a proprietary algorithm that incorporates a combination of quantitative EEG parameters and ranges from 0 to 100, with 100 being associated with wakefulness and 0 with an isoelectric EEG.
-
Spectral edge frequency
Time frame: 2 hours
Spectral edge frequency (SEF) is calculated from the power in frequency ranges. The area under the curve of the power spectrum is calculated and the SEF95 is derived by calculating the frequency at which power is separated into 95 and 5%. SEF90 is calculated in a similar way.
-
Burst suppression ratio
Time frame: 2 hours
Burst-suppression ratio would be 1.0 for an isoelectric EEG signal and 0 for an EEG signal without any isoelectric periods and represents the percentage of the previous 63 seconds epoch of EEG recognized as those periods longer than 0.5 second, during which the EEG voltage does not exceed approximately +5 to - 5 μV, indicating a severe reduction in the brain's neuronal activity and metabolic rate.
-
Original EEG
Time frame: 2 hours
Four simultaneous channels of frontal EEG waveforms reflect electrical activity of the frontal and pre-frontal cortices of the brain.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Beijing Tiantan Hospital
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- May 28, 2024
- Registry last updated
- Aug 5, 2024
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Ketamine Effect on Isoflurane Anesthesia
NCT03290495
Post-anesthesia Recovery
Minya, Minya Governorate, Egypt
View Trial Details
Completed
Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time
NCT01567852
Behavior, Orientation
Albuquerque, New Mexico, United States
View Trial Details