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NCT Number: NCT05283408

The Clinical Study of Dexmedetomidine and Esketamine Combined Infusion 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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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 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.

Primary outcomes

  1. Quality of recovery scores(QoR-15)

    Time frame: 1 day after operation

    Our primary outcome was quality of recovery scores(QoR-15) 1 day after operation

Secondary outcomes

  1. Intraoperative remifentanil total dose

    Time frame: Intraoperative

    Secondary Outcome Measure was remifentanil total dose during the perioperative period

  2. Pain visual analogue scale scores

    Time frame: The first 48 hours after operation

    Secondary Outcome Measure was pain visual analogue scale scores

  3. incidence of PONV

    Time frame: The first 48 hours after operation

    Secondary Outcome Measure was incidence of PONV

Sponsors and collaborators

Lead sponsor

Anqing Municipal Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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