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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    170
  • sponsor
    Anqing Municipal Hospital
Updated on 9 May 2022
Accepts healthy volunteers

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.

Details
Condition Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality
Treatment Dexmedetomidine infusion, Co-administration dexmedetomidine and low-dose esketamine infusion, Co-administration dexmedetomidine and high-dose esketamine infusion
Clinical Study IdentifierNCT05283408
SponsorAnqing Municipal Hospital
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

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
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