RecruitingNot ApplicableNCT06414941

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

Dexmedetomidine Combined With Esketamine Effects the Quality of Sleep


Sponsor

Anqing Municipal Hospital

Enrollment

105 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 65 Years

Inclusion Criteria2

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

Exclusion Criteria7

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

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Interventions

DRUGDexmedetomidine administration

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

DRUGDexmedetomidine plus low-dose esketamine administration

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.

DRUGDexmedetomidine plus high-dose esketamine administration

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.


Locations(1)

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, China

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NCT06414941