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

NCT06822088 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: (2024)ethical review L No.122CXPJJH124001-19
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esketamine; One-lung Ventilation; Oxygenation Indices

Keywords

esketamine; one-lung ventilation; Oxygenation; Intrapulmonary shunt fraction; Lung protection

Outcome Measures

Primary Outcomes (1)

• Oxygenation Index；Quality of postoperative recovery

  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.

  7 days

Study Arms (3)

Esketamine

EXPERIMENTAL

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.

Drug: Esketamine

Dexmedetomidine

ACTIVE COMPARATOR

Group D was given 1 ug/kg of dexmedetomidine 10min before surgery, and maintained at 0.4 ug/kg\*h after intubation until 30min before the end of surgery

Drug: Dexmedetomidine

Normal saline

PLACEBO COMPARATOR

Group C continued to pump the same amount of normal saline

Drug: Normal Saline

Interventions

Esketamine DRUG

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.

Esketamine

Dexmedetomidine DRUG

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.

Dexmedetomidine

Normal Saline DRUG

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

Normal saline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinqiao Qian: lead

Study Sites (1)

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Related Publications (10)

• Shi J, Yu T, Song K, Du S, He S, Hu X, Li X, Li H, Dong S, Zhang Y, Xie Z, Li C, Yu J. Dexmedetomidine ameliorates endotoxin-induced acute lung injury in vivo and in vitro by preserving mitochondrial dynamic equilibrium through the HIF-1a/HO-1 signaling pathway. Redox Biol. 2021 May;41:101954. doi: 10.1016/j.redox.2021.101954. Epub 2021 Mar 21.

  PMID: 33774474 BACKGROUND

• Xie Y, Jiang W, Zhao L, Wu Y, Xie H. Effect of dexmedetomidine on perioperative inflammation and lung protection in elderly patients undergoing radical resection of lung cancer. Int J Clin Exp Pathol. 2020 Oct 1;13(10):2544-2553. eCollection 2020.

  PMID: 33165407 BACKGROUND

• Cai SY, Liu A, Xie WX, Zhang XQ, Su B, Mao Y, Weng DG, Chen ZY. Esketamine mitigates mechanical ventilation-induced lung injury in chronic obstructive pulmonary disease rats via inhibition of the MAPK/NF-kappaB signaling pathway and reduction of oxidative stress. Int Immunopharmacol. 2024 Sep 30;139:112725. doi: 10.1016/j.intimp.2024.112725. Epub 2024 Jul 25.

  PMID: 39059100 BACKGROUND

• Tu W, Yuan H, Zhang S, Lu F, Yin L, Chen C, Li J. Influence of anesthetic induction of propofol combined with esketamine on perioperative stress and inflammatory responses and postoperative cognition of elderly surgical patients. Am J Transl Res. 2021 Mar 15;13(3):1701-1709. eCollection 2021.

  PMID: 33841692 BACKGROUND

• Campos JH, Feider A. Hypoxia During One-Lung Ventilation-A Review and Update. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2330-2338. doi: 10.1053/j.jvca.2017.12.026. Epub 2017 Dec 19. No abstract available.

  PMID: 29361458 BACKGROUND

• Durkin C, Romano K, Egan S, Lohser J. Hypoxemia During One-Lung Ventilation: Does It Really Matter? Curr Anesthesiol Rep. 2021;11(4):414-420. doi: 10.1007/s40140-021-00470-5. Epub 2021 Jul 7.

  PMID: 34254003 BACKGROUND

• Lumb AB, Slinger P. Hypoxic pulmonary vasoconstriction: physiology and anesthetic implications. Anesthesiology. 2015 Apr;122(4):932-46. doi: 10.1097/ALN.0000000000000569.

  PMID: 25587641 BACKGROUND

• Archer SL, Dunham-Snary KJ, Bentley R, Alizadeh E, Weir EK. Hypoxic Pulmonary Vasoconstriction: An Important Component of the Homeostatic Oxygen Sensing System. Physiol Res. 2024 Nov 29;73(S2):S493-S510. doi: 10.33549/physiolres.935431.

  PMID: 39589299 BACKGROUND

• Alday E, Nieves JM, Planas A. Oxygen Reserve Index Predicts Hypoxemia During One-Lung Ventilation: An Observational Diagnostic Study. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):417-422. doi: 10.1053/j.jvca.2019.06.035. Epub 2019 Jun 28.

  PMID: 31362907 BACKGROUND

• Nierengarten MB. Global cancer statistics 2022: The report offers a view on disparities in the incidence and mortality of cancer by sex and region worldwide and on the areas needing attention. Cancer. 2024 Aug 1;130(15):2568. doi: 10.1002/cncr.35444. No abstract available.

  PMID: 39032060 BACKGROUND

MeSH Terms

Interventions

Esketamine; Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

QianJ

CONTACT

8613308894416; fengrui981002@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 12, 2025
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 20, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2025.03.01-2026.03.01

Locations

CN (1)