## Protocol Section
### Identification Module
**NCT ID:** NCT06430645

**Brief Title:** Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia

**Official Title:** Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia

#### Organization Study ID Info
**ID:** esketamine_2024
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tiantan Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-05

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Tiantan Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing Tiantan Hospital

**Investigator Full Name:** Ruquan Han

**Investigator Title:** Director of Anesthesiology Department

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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. 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?

### Conditions Module

**Conditions:**

- Post-anesthesia Recovery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Drug：esketamine (0.3mg/kg)

**Intervention Names:**

- Drug: Esketamine

**Label:** low dose of esketamine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Drug：esketamine(0.6mg/kg)

**Intervention Names:**

- Drug: Esketamine

**Label:** high dose of esketamine

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Drug：0.9% saline

**Intervention Names:**

- Drug: Saline

**Label:** control group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- low dose of esketamine

**Description:** 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.

**Name:** Esketamine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- high dose of esketamine

**Description:** 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.

**Name:** Esketamine

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- control group

**Description:** 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.

**Name:** Saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Recovery time

**Time Frame:** 2 hours

#### Secondary Outcomes

**Description:** 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.

**Measure:** Explicit memory scores and implicit memory scores

**Time Frame:** 2 hours

**Description:** The judges of structured interviews includes three main categories: reports of no recall of any experiences, white reports and reports with specific content.

**Measure:** Subjective experience report

**Time Frame:** 2 hours

**Description:** Time to complete the Grooved Pegboard Test with dominant and non-dominant hand.

**Measure:** Grooved Pegboard Test points

**Time Frame:** 2 hours

**Description:** 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.

**Measure:** Patients state index

**Time Frame:** 2 hours

**Description:** 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.

**Measure:** Spectral edge frequency

**Time Frame:** 2 hours

**Description:** 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.

**Measure:** Burst suppression duration

**Time Frame:** 2 hours

**Description:** Four simultaneous channels of frontal EEG waveforms reflect electrical activity of the frontal and pre-frontal cortices of the brain.

**Measure:** Original EEG

**Time Frame:** 2 hours

### Eligibility Module

**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.

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** liyang0519@mail.ccmu.edu.cn

**Name:** Yang Li, Master

**Phone:** +86 18810637134

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** ruquan.han@ccmu.edu.cn

- **Name:** Ruquan Han, Ph.D

- **Phone:** 86-13701285393

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Tiantan Hospital, Capital Medical University

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100070

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing Tiantan Hospital

**Name:** Ruquan Han, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M271980

- Name: Esketamine

- Relevance: HIGH

- As Found: Days per week

- ID: M18307

- Name: Propofol

- Relevance: LOW

- As Found: Unknown

- ID: M19684

- Name: Sufentanil

- Relevance: LOW

- As Found: Unknown

- ID: M8608

- Name: Flurbiprofen

- Relevance: LOW

- As Found: Unknown

- ID: M117729

- Name: Dsuvia

- Relevance: LOW

- As Found: Unknown

- ID: M256863

- Name: Flurbiprofen axetil

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000629870

- Term: Esketamine

### Misc Info Module

- Version Holder: 2024-05-31
