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

Anqing Municipal Hospital

Status: Enrolling

Conditions: Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality

Treatments: Drug: Dexmedetomidine plus low-dose esketamine administration; Drug: Dexmedetomidine administration; Drug: Dexmedetomidine plus high-dose esketamine administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06414941

errtg555

Details and patient eligibility

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.

Enrollment: 105 estimated patients

Sex: Female

Ages: 25 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: Triple Blind

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105 participants in 3 patient groups

Dexmedetomidine on sleep quality with radical mastectomy

Experimental group

Description:

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 plus low-dose esketamine administration

Drug: Dexmedetomidine administration

Drug: Dexmedetomidine plus high-dose esketamine administration

Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy

Experimental group

Description:

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 plus low-dose esketamine administration

Drug: Dexmedetomidine administration

Drug: Dexmedetomidine plus high-dose esketamine administration

Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy

Experimental group

Description:

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 plus low-dose esketamine administration

Drug: Dexmedetomidine administration

Drug: Dexmedetomidine plus high-dose esketamine administration