The Clinical Study of Dexmedetomidine and Esketamine Combined Infusion Undergoing Modified Radical Mastectomy
- Conditions
- Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality
- Interventions
- Registration Number
- NCT05283408
- Lead Sponsor
- Anqing Municipal Hospital
- Brief Summary
BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine alleviated postoperative pain and improve the quality of recovery after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better alleviated postoperative pain and improve the the quality of recovery after modified radical mastectomy.
METHODS: One hundred and thirty-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 recovery (QoR-15) at 1 day after sugery and 3 day after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea, vomiting and bradycardia, hallucination, nightmare, as well as postoperative rescue analgesics and anti-emetics, recovery time, and extubation time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 135
- 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 infusion on recovey quality with radical mastectomy Dexmedetomidine infusion Drug: 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 Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy Dexmedetomidine infusion Drug: 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 infusion on recovey quality with radical mastectomy Co-administration dexmedetomidine and high-dose esketamine infusion Drug: 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 Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy Co-administration dexmedetomidine and low-dose esketamine infusion Drug: 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. Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy Co-administration dexmedetomidine and high-dose esketamine infusion Drug: 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. Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy Co-administration dexmedetomidine and high-dose esketamine infusion Drug: 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 infusion on recovey quality with radical mastectomy Co-administration dexmedetomidine and low-dose esketamine infusion Drug: 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 Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy Co-administration dexmedetomidine and low-dose esketamine infusion Drug: 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. Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy Dexmedetomidine infusion Drug: 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 Quality of recovery scores(QoR-15) 1 day after operation Our primary outcome was quality of recovery scores(QoR-15) 1 day after operation
- Secondary Outcome Measures
Name Time Method Intraoperative remifentanil total dose Intraoperative Secondary Outcome Measure was remifentanil total dose during the perioperative period
Pain visual analogue scale scores The first 48 hours after operation Secondary Outcome Measure was pain visual analogue scale scores
incidence of PONV The first 48 hours after operation Secondary Outcome Measure was incidence of PONV
Trial Locations
- Locations (1)
Department of Anqing Hospital Anesthesiology
🇨🇳Anqing, Anhui, China