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

NCT05283408 | Completed

• 1 other identifier: Xuwen521
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality

Keywords

Dexmedetomidine; esketamine; pain; recovery quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intraoperative remifentanil total dose

  Intraoperative

• Pain visual analogue scale scores

  The first 48 hours after operation

• incidence of PONV

  The first 48 hours after operation

Study Arms (3)

Dexmedetomidine infusion on recovey quality with radical mastectomy

EXPERIMENTAL

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; 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

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; 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

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

Interventions

Dexmedetomidine infusion DRUG

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; 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 DRUG

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.

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 DRUG

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

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ
• Scheduled for elective modified radical mastectomy

You may not qualify if:

• Severe respiratory disease
• Renal or hepatic insufficiency
• History of preoperative psychiatric
• Preoperative bradycardia
• Preoperative atrioventricular block
• Preoperative hypertension
• BMI\>30

Sponsors & Collaborators

• Anqing Municipal Hospital: lead

Study Sites (1)

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246000, China

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: April 10, 2022
• Primary Completion: March 20, 2023
• Study Completion: March 30, 2023
• Last Updated: April 13, 2023

Record last verified: 2022-03

Locations

CN (1)