Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia

NCT06430645 | Recruiting

• 1 other identifier: esketamine_2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does subanaesthetic doses of esketamine can accelerate recovery from propofol anaesthesia?
2. 2.What will happen to brain network connection after different doses of esketamine during propofol anesthesia?

Conditions

Post-anesthesia Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Explicit memory scores and implicit memory scores

  2 hours

• Subjective experience report

  2 hours

• Grooved Pegboard Test points

  2 hours

• Patients state index

  2 hours

• Spectral edge frequency

  2 hours

Study Arms (3)

low dose of esketamine

EXPERIMENTAL

Drug：esketamine (0.3mg/kg)

Drug: Esketamine

high dose of esketamine

EXPERIMENTAL

Drug：esketamine(0.6mg/kg)

Drug: Esketamine

control group

EXPERIMENTAL

Drug：0.9% saline

Drug: Saline

Interventions

Esketamine DRUG

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.

low dose of esketamine

Saline DRUG

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.

control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Interventions

Esketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ruquan Han, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Li, Master

CONTACT

+86 18810637134; liyang0519@mail.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 28, 2024
• Study Start: May 5, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

CN (1)