The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy
- Conditions
- Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality
- Interventions
- Registration Number
- NCT06414941
- Lead Sponsor
- Anqing Municipal Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 105
- American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ
- Scheduled for elective modified radical mastectomy
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative psychiatric
- Preoperative bradycardia
- Preoperative atrioventricular block
- Preoperative hypertension
- BMI>30
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine on sleep quality with radical mastectomy Dexmedetomidine administration 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 Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy Dexmedetomidine plus low-dose esketamine administration 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. Dexmedetomidine on sleep quality with radical mastectomy Dexmedetomidine plus high-dose esketamine administration 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 Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy Dexmedetomidine administration 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. Dexmedetomidine on sleep quality with radical mastectomy Dexmedetomidine plus low-dose esketamine administration 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 Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy Dexmedetomidine administration 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. Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy Dexmedetomidine plus low-dose esketamine administration 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. Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy Dexmedetomidine plus high-dose esketamine administration 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. Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy Dexmedetomidine plus high-dose esketamine administration 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.
- Primary Outcome Measures
Name Time Method Pittsburgh sleep quality index (PSQI) the day after surgery Our primary outcome was Pittsburgh sleep quality index (PSQI) at the day after surgery
- Secondary Outcome Measures
Name Time Method Pittsburgh sleep quality index (PSQI) 1 day after surgery Our primary outcome was Pittsburgh sleep quality index (PSQI) on 1 day after surgery
pain visual analogue scale scores The first 48 hours after operation Our primary outcome was pain visual analogue scale scores
Trial Locations
- Locations (1)
Department of Anqing Hospital Anesthesiology
🇨🇳Anqing, Anhui, China