The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy

NCT06414941 | Recruiting DMC

• 1 other identifier: errtg555
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality

Keywords

Esketamine; Sleep quality; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Pittsburgh sleep quality index (PSQI)

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

  the day after surgery

Secondary Outcomes (2)

• Pittsburgh sleep quality index (PSQI)

  1 day after surgery

• pain visual analogue scale scores

  The first 48 hours after operation

Study Arms (3)

Dexmedetomidine on sleep quality with radical mastectomy

EXPERIMENTAL

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

Drug: Dexmedetomidine administration; Drug: Dexmedetomidine plus low-dose esketamine administration; Drug: Dexmedetomidine plus high-dose esketamine administration

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

EXPERIMENTAL

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.

Drug: Dexmedetomidine administration; Drug: Dexmedetomidine plus low-dose esketamine administration; Drug: Dexmedetomidine plus high-dose esketamine administration

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

EXPERIMENTAL

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.

Drug: Dexmedetomidine administration; Drug: Dexmedetomidine plus low-dose esketamine administration; Drug: Dexmedetomidine plus high-dose esketamine administration

Interventions

Dexmedetomidine administration DRUG

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

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

Dexmedetomidine plus low-dose esketamine administration DRUG

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.

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

Dexmedetomidine plus high-dose esketamine administration DRUG

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.

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

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anqing Municipal Hospital: lead

Study Sites (1)

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246003, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xu si qi, Doctor

CONTACT

13865192106; errtg555@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 20, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CN (1)