Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia

Post-anesthesia Recovery Clinical Trial

Official title:

Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430645
• Other study ID #: esketamine_2024
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Beijing Tiantan Hospital
• Contact: Yang Li, Master
• Phone: +86 18810637134
• Email: liyang0519[@]mail.ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post-anesthesia Recovery

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery time	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.	2 hours
Secondary	Explicit memory scores and implicit memory scores	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.	2 hours
Secondary	Subjective experience report	The judges of structured interviews includes three main categories: reports of no recall of any experiences, white reports and reports with specific content.	2 hours
Secondary	Grooved Pegboard Test points	Time to complete the Grooved Pegboard Test with dominant and non-dominant hand.	2 hours
Secondary	Patients state index	Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration.	2 hours
Secondary	Spectral edge frequency	Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration.	2 hours
Secondary	Burst suppression duration	Processed EEG will be recorded using Sedline (Masimo, Irvine, CA, USA). This includes patients state index (PSI), spectral edge frequency(SEF), and burst suppression duration.	2 hours
Secondary	Original EEG	Four simultaneous channels of frontal EEG waveforms reflect electrical activity of the frontal and pre-frontal cortices of the brain.	2 hours