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

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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality
• Intervention / Treatment: Drug: Dexmedetomidine infusion; Drug: Co-administration dexmedetomidine and low-dose esketamine infusion; Drug: Co-administration dexmedetomidine and high-dose esketamine infusion

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Anqing, Anhui, China, 246000
      • Department of Anqing Hospital Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine infusion on recovey quality with radical mastectomy; 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	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; Drug: 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.; Drug: 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.
Experimental: Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy; 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.	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; Drug: 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.; Drug: 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.
Experimental: Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy; 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.	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; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery scores(QoR-15)	Our primary outcome was quality of recovery scores(QoR-15) 1 day after operation	1 day after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative remifentanil total dose	Secondary Outcome Measure was remifentanil total dose during the perioperative period	Intraoperative
Pain visual analogue scale scores	Secondary Outcome Measure was pain visual analogue scale scores	The first 48 hours after operation
incidence of PONV	Secondary Outcome Measure was incidence of PONV	The first 48 hours after operation

Collaborators and Investigators

• Sponsor: Anqing Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Estimate): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: pain; esketamine; Dexmedetomidine; recovery quality
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Dexmedetomidine; Esketamine
• Other Study ID Numbers: Xuwen521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No