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Starting soon Phase 4

Effects of Esketamine on Oxygenation and Quality of Recovery in Patients Undergoing Thoracoscopic Surgery

NCT06822088 · tracked via the Priya Life Science China tracker
Sponsor
Jinqiao Qian
Phase
Phase 4
Started
2025-03-01
Last updated
2025-02-12

Condition(s) studied

EsketamineOne-lung VentilationOxygenation Indices

Investigational drug(s) / intervention(s)

Esketamine →Dexmedetomidine →Normal Saline

Esketamine: A total of 126 patients undergoing thoracoscopic surgery under elective general anesthesia were randomly divided into three groups: normal saline group (group C), dexmedetomidine group (group D), eschloroacetone group (group E) and dexmedetomidine group (group D), with 42 cases in each group. Group C was continuously injected with the same amount of normal saline, group D was given dextrometin 1 ug/kg load 10min before surgery, and maintained at 0.4 ug/kg\*h after intubation until 30min before the end of surgery. Group E was given esketamine 0.2 mg/kg 10min before surgery, and maintained at 0.15 mg/kg\*h after intubation until 30min before surgery. Other anesthetic induction and maintenance drugs were consistent among the three groups.

Dexmedetomidine: group D was given Dexmedetomidine 1 ug/kg load 10min before surgery, and maintained at 0.4 ug/kg\*h after intubation until 30min before the end of surgery.

Normal Saline: Group C was continuously injected with the same amount of normal saline,

Study summary

A total of 126 patients undergoing elective thoracoscopic surgery under general anesthesia were randomly divided into three groups: normal saline group (Group C), dexmedetomidine group (Group D), and esketamine group (Group E),with 42 patients in each group.In Group C,an equal volume of normal saline was continuously infused. In Group D,a loading dose of dexmedetomidine (1 μg/kg) was administered 10 min before induction of anesthesia, followed by a continuous infusion at a rate of 0.4 μg·kg-1·h-1 until 30 minutes before the end of the surgery. In Group E, 0.2mg/kg esketamine was infused intravenously before the induction of anesthesia for 10 min, and then maintained at 0.15 mg·kg-1·h-1 until 30 minutes before the end of the surgery. The primary outcome measures of this study were the oxygenation index (OI) at the following time points: before one-lung ventilation (OLV) (T1), 30 minutes after OLV initiation (T2), and 60 minutes after OLV initiation (T3). The secondary outcome measures included: (1)The duration of OLV, blood loss, fluid infusion volume, the dosages of propofol, remifentanil and vasoactive drugs(ephedrine and atropine) were recorded in each group.(2)Heart rate (HR) and mean arterial pressure (MAP) were recorded at the following time points: upon entering the operating room (T0), before OLV (T1), 30 minutes after OLV initiation (T2), 60 minutes after OLV initiation (T3), before extubation (T4), and 5 minutes after extubation (T5).(3)Blood gas anlaysis parameters,airway plateau pressure,tidal volume and positive end-expiratory pressure were recorded from T1 to T3,and dynamic lung compliance and intrapulmonary shunt fraction were calculated.(4) White blood cell counts, neutrophil percentage,and C-reactive protein (CRP) levels were recorded preoperatively and 24 hours postoperatively.(5)Postoperative pain was evaluated using the visual analogue score (VAS) at 2, 6, 12, and 24 hours after surgery, and the number of patients requiring rescue analgesia in each group was recorded. The occurrence of postoperative adverse reactions and postoperative pulmonary complications (PCCs) within one week after surgery were recorded. The postoperative quality of recovery was evaluated using the QOR-15 scale at 24 and 48 hours after surgery,and the postoperative hospital stay was recorded.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Patients undergoing thoracoscopic surgery under elective general anesthesia in the First Affiliated Hospital of Kunming Medical University; * Age 18-65 years old; * BMI18\~30 kg/m2; * American Society of Anesthesiologistsgrade I\~III; * No contraindications to drugs; * All patients and their families agreed to participate in this study and signed informed consent Exclusion Criteria: * Patients with severe sinus bradycardia (heart rate \<50 beats/min) and atrioventricular block; * Respiratory infection and non-steroidal anti-inflammatory drugs or hormone drugs taken within 2 weeks before surgery; * severe liver and kidney dysfunction and immune system diseases, uncontrolled hypertension, diabetes; * History of preoperative chemoradiotherapy.

Primary outcome measure(s)

  • Oxygenation Index;Quality of postoperative recovery — 7 days
    Esketamine can improve oxygenation during one-lung ventilation in patients undergoing thoracoscopy, producing a lung-protective effect; at the same, it improves the quality of postoperative recovery in patients.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Kunming Medical University Kunming Yunnan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06822088 on ClinicalTrials.gov ↗ ← All trials in China