Post-anesthesia RecoveryNCT06430645
Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia
A study testing Esketamine and Saline in people with Post-anesthesia Recovery, run by Beijing Tiantan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Post-anesthesia Recovery
- What is being tested?
- Esketamine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged from 18 years to 50 years
- Patients scheduled for elective operative hysteroscopy
- Willing to sign informed consent
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Ruquan Han, Ph.D, 86-13701285393, ruquan.han@ccmu.edu.cn
About this study
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:
- Does subanaesthetic doses of esketamine can accelerate recovery from propofol anaesthesia?
- What will happen to brain network connection after different doses of esketamine during propofol anesthesia?
- Conditions
- Post-anesthesia Recovery
- Being tested
- Esketamine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
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.
EsketamineDrug
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.
SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| low dose of esketamine | Experimental | Drug：esketamine (0.3mg/kg) Receives: Drug: Esketamine |
| high dose of esketamine | Experimental | Drug：esketamine(0.6mg/kg) Receives: Drug: Esketamine |
| control group | Experimental | Drug：0.9% saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (7)
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.
Measured: 2 hours
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.
Measured: 2 hours
Grooved Pegboard Test points
Time to complete the Grooved Pegboard Test with dominant and non-dominant hand.
Measured: 2 hours
Patients state index
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.
Measured: 2 hours
Spectral edge frequency
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.
Measured: 2 hours
Burst suppression ratio
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.
Measured: 2 hours
Original EEG
Four simultaneous channels of frontal EEG waveforms reflect electrical activity of the frontal and pre-frontal cortices of the brain.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start5 May 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-anesthesia RecoveryStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430645
- Sponsor's protocol ID
- esketamine_2024
- Status last verified
- Aug 2024
- First submitted
- 9 May 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia
- ClinicalTrials.gov ID
- NCT06430645
- Acronym / sponsor ID
- esketamine_2024
- Conditions
- Post-anesthesia Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does subanaesthetic doses of esketamine can accelerate recovery from propofol anaesthesia?
- What will happen to brain network connection after different doses of esketamine during propofol anesthesia?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose of esketamine | Experimental | Drug: EsketamineDrug：esketamine (0.3mg/kg) |
| high dose of esketamine | Experimental | Drug: EsketamineDrug：esketamine(0.6mg/kg) |
| control group | Experimental | Drug: SalineDrug：0.9% saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged from 18 years to 50 years
- Patients scheduled for elective operative hysteroscopy
- Willing to sign informed consent
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineSufentanil(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 | low dose of esketamine |
| EsketamineSufentanil(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 | high dose of esketamine |
| SalineSufentanil(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. | Drug | control group |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruquan Han, PhD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and Saline in people with Post-anesthesia Recovery, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Li, Master (+86 18810637134, liyang0519@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.