An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery

Phase 4

Completed

• Conditions: Thoracoscopic Surgery; Esketamine
• Interventions: Drug: Esketamine

• Registration Number: NCT05458453
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-01
• Study Start: 2022-07-07
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-14
• Status Verified: 2022-08
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-28
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients undergoing thoracoscopic surgery are required to use PCIA for analgesia;

2. ASA grade I-III;

3. The patient's age is 18-75 years old; 4、18.5 < BMI < 28；

4. Obtain the informed consent of patients and their families;

Exclusion Criteria

1. Patients with previous history of thoracic surgery or combined history of thoracic trauma;
2. Patients with severe hypertension and poor control;
3. Patients with hyperthyroidism and poor control;
4. Patients at risk of increased intracranial pressure;
5. Patients with mental illness;
6. Patients who are allergic to any drug in the test;
7. Patients who take anti-inflammatory drugs, opioids or related diseases for a long time;
8. Pregnant or lactating patients;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esketamine arm	Esketamine	Self-controlled intravenous analgesia pump was used for continuous injection, and it was prepared according to sufentanil 1.5ug/ml+ esketamine 0.75ug/ml+16mg ondansetron. After the operation, the analgesic pump was connected, and sufentanil 0.1ug/kg/h+ e sketamine 0.05mg/kg/h was pumped continuously for 24 hours. The continuous infusion of analgesia pump is (kg body weight/15) ml/h. (e.g. 60kg, pump speed 4ml/h, total amount 96ml).

Primary Outcome Measures

Name	Time	Method
Respiratory rate 0	Before anesthesia induction	Respiratory rate before anesthesia induction
Respiratory rate 1	Within 5 minutes after extubation	Respiratory rate after extubation
Tidal volume 1	Within 5 minutes after extubation	Tidal volume after extubation
Minute ventilation volume 1	Within 5 minutes after extubation	Minute ventilation volume after extubation
Minute ventilation volume 3	postoperative day 1 (POD1) afternoon	Minute ventilation volume on the first afternoon
Minute ventilation volume 5	postoperative day 2 (POD2) afternoon	Minute ventilation volume on the next afternoon
Minute ventilation volume 2	postoperative day 1 (POD1) morning	Minute ventilation volume on the first morning
Minute ventilation volume 0	Before anesthesia induction	Minute ventilation volume before anesthesia induction
Tidal volume 3	Day1（The afternoon of the first day after surgery）	Tidal volume on the first afternoon after surgery
Tidal volume 5	day 2 ( second afternoon after surgery)	Tidal volume on the next afternoon after surgery
Minute ventilation volume 4	postoperative day 2 (POD2) morning	Minute ventilation volume on the next morning
Tidal volume 0	Before anesthesia induction	Tidal volume before anesthesia induction
Respiratory rate 5	day 2 ( second afternoon after surgery)	Respiratory rate on the next afternoon after surgery
Tidal volume 2	Day1 （The first morning after surgery）	Tidal volume on the first morning after surgery
Tidal volume 4	day 2 ( second morning after surgery)	Tidal volume on the next morning after surgery
Respiratory rate 2	Day1 （The first morning after surgery）	Respiratory rate on the first morning after surgery
Respiratory rate 3	Day1 （The afternoon of the first day after surgery）	Respiratory rate on the first afternoon after surgery
Respiratory rate 4	day 2 ( second morning after using surgery)	Respiratory rate on the next morning after surgery

Secondary Outcome Measures

Name	Time	Method
Vas score 2	postoperative day 1 (POD1) morning	The higher the score, the more painful it is.
Vas score 4	postoperative day 2 (POD2) morning	The higher the score, the more painful it is.
Oxygenation index 3	postoperative Day 1	Oxygenation index (calculated as PaO2/FiO2) on the first morning
Oxygenation index 0	Before anesthesia induction	Oxygenation index (calculated as PaO2/FiO2) before anesthesia induction
Oxygenation index 1	Within 5 minutes after extubation	Oxygenation index (calculated as PaO2/FiO2) after extubation
Vas score 1	Within 5 minutes after extubation	The higher the score, the more painful it is.
Vas score 3	postoperative day 1 (POD1) afternoon	The higher the score, the more painful it is.
Vas score 5	postoperative day 2 (POD2) afternoon	The higher the score, the more painful it is.
Incidence of postoperative pulmonary complications during hospitalization	From end of the surgery to hospital discharge with about mean of 7 days after surgery	postoperative pulmonary complications during hospitalization was assessed using the Melbourne Group Scale, whcih reached four or more of the 8 criteria would be diagnosed with postoperative pulmonary complications.
incidence of hypoxemia during the first and second day after surgery	from end of the surgery to the second day after surgery	hypoxemia is defined as SpO2\<92% during the first and second day after surgery

Trial Locations

Locations (2)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China