Clinical trial

Effect of Dexmedetomidine and Esketamine Combined Infusion on Postoperative Pain and Recovey Quality Undergoing Modified Radical Mastectomy

Name
Xuwen521
Description
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.
Trial arms
Trial start
2022-04-10
Estimated PCD
2023-03-20
Trial end
2023-03-30
Status
Completed
Treatment
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
Arms:
Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy, Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy, Dexmedetomidine infusion on recovey quality with radical mastectomy
Co-administration dexmedetomidine and low-dose esketamine 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.
Arms:
Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy, Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy, Dexmedetomidine infusion on recovey quality with radical mastectomy
Co-administration dexmedetomidine and high-dose esketamine 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.
Arms:
Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy, Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy, Dexmedetomidine infusion on recovey quality with radical mastectomy
Size
135
Primary endpoint
Quality of recovery scores(QoR-15)
1 day after operation
Eligibility criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ * Scheduled for elective modified radical mastectomy Exclusion Criteria: * Severe respiratory disease * Renal or hepatic insufficiency * History of preoperative psychiatric * Preoperative bradycardia * Preoperative atrioventricular block * Preoperative hypertension * BMI\>30
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 135, 'type': 'ACTUAL'}}
Updated at
2023-04-13

1 organization

3 products

3 indications

Indication
Dexmedetomidine
Indication
Esketamine