The Clinical Study of Dexmedetomidine and Esketamine Combined Infusion Undergoing Modified Radical Mastectomy

Anqing Municipal Hospital

Status: Completed

Conditions: Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality

Treatments: Drug: Co-administration dexmedetomidine and low-dose esketamine infusion; Drug: Co-administration dexmedetomidine and high-dose esketamine infusion; Drug: Dexmedetomidine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05283408

Xuwen521

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups

Dexmedetomidine infusion on recovey quality with radical mastectomy

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine infusion

Drug: Co-administration dexmedetomidine and low-dose esketamine infusion

Drug: Co-administration dexmedetomidine and high-dose esketamine infusion

Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine infusion

Drug: Co-administration dexmedetomidine and low-dose esketamine infusion

Drug: Co-administration dexmedetomidine and high-dose esketamine infusion

Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine infusion

Drug: Co-administration dexmedetomidine and low-dose esketamine infusion

Drug: Co-administration dexmedetomidine and high-dose esketamine infusion