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Effects of low-dose esketamine on hypoxaemia during thoracoscopic non-tracheal intubation anaesthesia: protocol for a double-blind, randomised controlled trial.

Jing Tian, Mengchao Xu, Songjie Li, Yi Liu, Wang Li, Wei Sun, Changping Gu

BMJ Open January 27, 2026 DOI: 10.1136/bmjopen-2025-109633 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Double-blind Peer reviewed
Population Patients scheduled for non-intubation video-assisted thoracoscopic surgery at Shandong Provincial Hospital Affiliated to Shandong First Medical University
Interventions Esketamine Normal saline (placebo)
Topics Esketamine
Keywords Adult anaesthesia Hypoxia Thoracic surgery
Key findings The study will test whether low-dose esketamine reduces the incidence of intraoperative hypoxaemia compared to placebo in patients undergoing non-intubation thoracoscopic surgery.

Abstract

Non-tracheal intubation anaesthesia for thoracoscopic surgery is associated with intraoperative hypoxaemia. Esketamine has both sedative and analgesic effects, which can increase lung compliance, reduce airway resistance and relax the respiratory smooth muscles. This study will investigate the effectiveness of low-dose esketamine in reducing the incidence of intraoperative hypoxaemia and other adverse events in patients undergoing thoracoscopic surgery without intubation anaesthesia. This randomised controlled trial will enrol patients scheduled for non-intubation video-assisted thoracoscopic surgery at Shandong Provincial Hospital Affiliated to Shandong First Medical University. Eligible participants will be randomly allocated in a 1:1 ratio to receive either the esketamine group or the normal saline (placebo) group. The primary outcomes are the incidence of hypoxaemia and the time to its onset, with hypoxaemia defined as an intraoperative pulse oximetry ≤90% lasting for at least 10 s. Secondary outcomes include the incidence of intraoperative hypercapnia (Partial pressure of carbon dioxide (PCO2) ≥60 mm Hg); concentrations of interleukin (IL)-6 and IL-8 at the end of surgery; postoperative Visual Analogue Scale scores; time to recovery of spontaneous respiration after laryngeal mask placement; time to laryngeal mask removal (measured from the end of surgery); awakening time; incidence of bradycardia (heart rate 20% reduction in blood pressure from the baseline value); incidence of ≤24-hour postoperative nausea and vomiting and hoarseness; time to ambulation, drinking and eating postoperatively; incidence of pulmonary complications within 2 weeks postoperatively; and length of hospital stay. All analyses will be performed based on using a modified intention-to-treat population principle. The study protocol has been reviewed and approved by the Ethics Committee of Shandong First Medical University Affiliated Provincial Hospital, with approval number SWYX 2025-714. The trial is also registered with the Chinese Clinical Trial Registry under the identifier ChiCTR2400094821. On completion, the study findings will be prepared for publication and submitted to a relevant peer-reviewed journal. ChiCTR2400094821.

Comparable studies

Other randomized controlled trials on esketamine, most cited first.

Study Year Design Participants
Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study Adults with moderate to severe nonpsychotic depression and a history of nonresponse to... 2019 Phase 3, double-blind, active-controlled, multicenter randomized controlled trial n = 227
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression Adults with treatment-resistant depression who achieved stable remission or stable... 2019 Phase 3, multicenter, double-blind, randomized withdrawal study n = 297
Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression Adults with DSM-IV-TR diagnosis of major depressive disorder and history of inadequate... 2017 Phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study n = 67
Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study Depressed patients at imminent risk for suicide 2018 Randomized controlled trial n = 68
Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) Adults with moderate-to-severe depression and nonresponse to at least two... 2019 Randomized controlled trial n = 346

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