## Protocol Section
### Identification Module
**NCT ID:** NCT06414941

**Brief Title:** The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy

**Official Title:** Dexmedetomidine Combined With Esketamine Effects the Quality of Sleep

#### Organization Study ID Info
**ID:** errtg555
#### Organization
**Class:** OTHER
**Full Name:** Anqing Municipal Hospital
### Status Module
#### Completion Date
**Date:** 2024-10-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

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

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Anqing Municipal Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine improve the quality of sleep after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better improve the the quality of sleep after modified radical mastectomy.

METHODS: One hundred and five women with elective modified radical mastectomy were randomly divided into 3 groups: Patients in group D received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation. Patients in group DE1 received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. Patients in group DE2 received received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. Primary outcome was the quality of sleep (PSQI) at the day after surgery and 1 day after surgery. The secondary outcomes included MAP, HR, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea and vomiting, hallucination, as well as agitation, drowness, postoperative rescue analgesics and anti-emetics, recovery time, and extubation time.

### Conditions Module

**Conditions:**

- Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality

**Keywords:**

- Esketamine

- Sleep quality

- Dexmedetomidine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 105

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Dexmedetomidine infusion Patients received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation

**Intervention Names:**

- Drug: Dexmedetomidine administration

- Drug: Dexmedetomidine plus low-dose esketamine administration

- Drug: Dexmedetomidine plus high-dose esketamine administration

**Label:** Dexmedetomidine on sleep quality with radical mastectomy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Dexmedetomidine and low-dose eskeamine combined infusion Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively.

**Intervention Names:**

- Drug: Dexmedetomidine administration

- Drug: Dexmedetomidine plus low-dose esketamine administration

- Drug: Dexmedetomidine plus high-dose esketamine administration

**Label:** Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Dexmedetomidine and high-dose eskeamine combined infusion Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively.

**Intervention Names:**

- Drug: Dexmedetomidine administration

- Drug: Dexmedetomidine plus low-dose esketamine administration

- Drug: Dexmedetomidine plus high-dose esketamine administration

**Label:** Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dexmedetomidine on sleep quality with radical mastectomy

- Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy

- Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy

**Description:** atients received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation

**Name:** Dexmedetomidine administration

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Dexmedetomidine on sleep quality with radical mastectomy

- Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy

- Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy

**Description:** Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively.

**Name:** Dexmedetomidine plus low-dose esketamine administration

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Dexmedetomidine on sleep quality with radical mastectomy

- Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy

- Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy

**Description:** Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively.

**Name:** Dexmedetomidine plus high-dose esketamine administration

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Our primary outcome was Pittsburgh sleep quality index (PSQI) at the day after surgery

**Measure:** Pittsburgh sleep quality index (PSQI)

**Time Frame:** the day after surgery

#### Secondary Outcomes

**Description:** Our primary outcome was Pittsburgh sleep quality index (PSQI) on 1 day after surgery

**Measure:** Pittsburgh sleep quality index (PSQI)

**Time Frame:** 1 day after surgery

**Description:** Our primary outcome was pain visual analogue scale scores

**Measure:** pain visual analogue scale scores

**Time Frame:** The first 48 hours after operation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ
* Scheduled for elective modified radical mastectomy

Exclusion Criteria:

* Severe respiratory disease
* Renal or hepatic insufficiency
* History of preoperative psychiatric
* Preoperative bradycardia
* Preoperative atrioventricular block
* Preoperative hypertension
* BMI\>30

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 25 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** errtg555@163.com

**Name:** Xu si qi, Doctor

**Phone:** 13865192106

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Anqing

**Country:** China

**Facility:** Department of Anqing Hospital Anesthesiology

**State:** Anhui

**Status:** RECRUITING

**Zip:** 246003

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- 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: Analg

- Name: Analgesics

- Abbrev: PsychDr

- Name: Psychotropic Drugs

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M271980

- Name: Esketamine

- Relevance: HIGH

- As Found: Days per week

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- 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: D000020927

- Term: Dexmedetomidine

- ID: C000629870

- Term: Esketamine

### Misc Info Module

- Version Holder: 2024-05-31
