Actively Recruiting

Phase Not Applicable
Age: 25Years - 65Years
FEMALE
Healthy Volunteers
NCT06414941

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

Led by Anqing Municipal Hospital · Updated on 2024-05-16

105

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 25Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 25 to 65 years
  • American Society of Anesthesiologists physical status I or II
  • Scheduled for elective modified radical mastectomy
Not Eligible

You will not qualify if you...

  • Severe respiratory disease
  • Kidney or liver failure
  • History of psychiatric illness before surgery
  • Preoperative slow heart rate (bradycardia)
  • Preoperative heart conduction problems (atrioventricular block)
  • Preoperative high blood pressure (hypertension)
  • Body mass index over 30

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, China, 246003

Actively Recruiting

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Research Team

X

Xu si qi, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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