An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery

NCT ID: NCT05458453

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2023-02-28

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.

Conditions

Esketamine; Thoracoscopic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Esketamine arm

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).

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

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+ esketamine 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).

Sufentanil arm

Continuous pumping with self-controlled intravenous analgesia pump. According to sufentanil 1.5ug/ml+16mg ondansetron. At the end of the operation, connect the analgesic pump, and pump it with sufentanil at 0.1ug/kg/h 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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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+ esketamine 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).

Intervention Type: DRUG

Eligibility Criteria

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；

5. 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

References

Fu M, Xu R, Chen G, Zheng X, Shu B, Huang H, Duan G, Chen Y. Postoperative esketamine improves ventilation after video-assisted thoracoscopic lung resection: A double-blinded randomized controlled trial. Heliyon. 2024 Jan 24;10(3):e25100. doi: 10.1016/j.heliyon.2024.e25100. eCollection 2024 Feb 15.

Reference Type: DERIVED

PMID: 38322862 (View on PubMed)

Other Identifiers

Esketamine and thoracoscopic

Identifier Type: -

Identifier Source: org_study_id