NCT05458453

An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery

Completed Phase 4 Last updated 16 August 2023

What this trial tests

Phase 4 trial testing Esketamine in Esketamine in 80 participants. Completed in 28 February 2023.

Timeline

7 July 2022

Primary endpoint
20 February 2023

28 February 2023

Quick facts

Lead sponsor	The Second Affiliated Hospital of Chongqing Medical University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	7 July 2022
Primary completion	20 February 2023
Estimated completion	28 February 2023
Sites	2 locations across China

Drugs / interventions tested

• Esketamine (ESKETAMINE) — full drug profile →

Conditions studied

• Esketamine — all drugs for Esketamine →
• Thoracoscopic Surgery — all drugs for Thoracoscopic Surgery →

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Who can join

Adults 18 to 75, any sex, with Esketamine or Thoracoscopic Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Thoracic surgery can produce severe postoperative acute pain, which can easily lead to cough weakness, atelectasis, respiratory restriction, pneumonia, hypoxemia, secretion retention, respiratory failure and other adverse events. Esketamine can reduce the demand of analgesic opioids, reduce the respiratory depression caused by opioids, improve ventilation, significantly reduce postoperative pain and prolong the analgesic time after thoracic surgery. Therefore, the application of esketamine in postoperative analgesia of patients undergoing thoracoscopic surgery may help to improve the respiratory function of clinical patients and further improve the postoperative analgesia effect, so as to achieve the purpose of accelerating the surgical rehabilitation of patients undergoing thoracoscopic surgery. Esketamine is rarely used in perioperative period in China, and the development of its safe and reasonable application methods and potential role in perioperative anesthesia needs further research and verification. Generally speaking, at present, there is still a lack of evaluation of ketamine in improving respiratory function, pain, anxiety and depression after thoracoscopic surgery, and there is no direct clinical evidence.

At present, sufentanil is the most commonly used drug for postoperative analgesia in patients undergoing clinical surgery. As a strong opioid, although sufentanil can provide good analgesic effect, the respiratory depression caused by sufentanil is not conducive to the recovery of postoperative lung function in patients undergoing thoracic surgery. The action sites of esketamine include N- methyl-aspartic acid (NMDA) receptor, opioid receptor, monoamine receptor, M cholinergic receptor, sodium channel, calcium channel, etc., which can relieve respiratory depression caused by opioids, stimulate respiration, relax airway smooth muscle, prevent hyperalgesia caused by opioids, reduce the dosage of postoperative analgesics and prolong the duration of postoperative analgesia. Therefore, esketamine is likely to improve postoperative respiratory function of patients after thoracoscopic surgery and play a good role. To sum up, this study is intended to include patients undergoing elective thoracoscopic surgery. Through a prospective randomized controlled double-blind clinical trial, different analgesic drugs of intravenous patient-controlled analgesia and simple conventional opioid analgesic sufentanil are used as the control. Combined with the investigation of preoperative and postoperative tidal volume, oxygenation index, postoperative pain and postoperative recovery outcome, the effects of esketamine on postoperative respiratory function, postoperative pain and overall rehabilitation of these patients are compared, so as to provide direct clinical evidence for improving postoperative lung function of patients undergoing elective thoracoscopic surgery, and at the same time, provide a choice for thoracoscopic surgery.

To explore the effect of esketamine on improving postoperative respiratory function, pain, depression and anxiety and overall rehabilitation of patients undergoing thoracoscopic surgery. Compound esketamine is used for postoperative analgesia, thus providing direct clinical evidence for improving postoperative pulmonary function of patients undergoing elective thoracoscopic surgery, and providing reference for improving postoperative pain, anxiety and depression of patients undergoing elective thoracoscopic surgery.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Postoperative esketamine improves ventilation after video-assisted thoracoscopic lung resection: A double-blinded randomized controlled trial.
   Fu M, Xu R, Chen G, Zheng X, et al · · 2024 · cited 7× · PMID 38322862 · DOI 10.1016/j.heliyon.2024.e25100
2. Postoperative esketamine improves ventilation after video-assisted thoracoscopic lung resection: A double-blinded randomized controlled trial
   Fu M, Xu R, Chen G, Zheng X, et al · · 2024