An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery

NCT05458453 | Completed Phase 4 DMC

• 1 other identifier: Esketamine and thoracoscopic
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (18)

• Minute ventilation volume 0

  Minute ventilation volume before anesthesia induction

  Before anesthesia induction

• Minute ventilation volume 1

  Minute ventilation volume after extubation

  Within 5 minutes after extubation

• Minute ventilation volume 2

  Minute ventilation volume on the first morning

  postoperative day 1 (POD1) morning

• Minute ventilation volume 3

  Minute ventilation volume on the first afternoon

  postoperative day 1 (POD1) afternoon

• Minute ventilation volume 4

  Minute ventilation volume on the next morning

  postoperative day 2 (POD2) morning

• Minute ventilation volume 5

  Minute ventilation volume on the next afternoon

  postoperative day 2 (POD2) afternoon

• Tidal volume 0

  Tidal volume before anesthesia induction

  Before anesthesia induction

• Tidal volume 1

  Tidal volume after extubation

  Within 5 minutes after extubation

• Tidal volume 2

  Tidal volume on the first morning after surgery

  Day1 （The first morning after surgery）

• Tidal volume 3

  Tidal volume on the first afternoon after surgery

  Day1（The afternoon of the first day after surgery）

• Tidal volume 4

  Tidal volume on the next morning after surgery

  day 2 ( second morning after surgery)

• Tidal volume 5

  Tidal volume on the next afternoon after surgery

  day 2 ( second afternoon after surgery)

• Respiratory rate 0

  Respiratory rate before anesthesia induction

  Before anesthesia induction

• Respiratory rate 1

  Respiratory rate after extubation

  Within 5 minutes after extubation

• Respiratory rate 2

  Respiratory rate on the first morning after surgery

  Day1 （The first morning after surgery）

• Respiratory rate 3

  Respiratory rate on the first afternoon after surgery

  Day1 （The afternoon of the first day after surgery）

• Respiratory rate 4

  Respiratory rate on the next morning after surgery

  day 2 ( second morning after using surgery)

• Respiratory rate 5

  Respiratory rate on the next afternoon after surgery

  day 2 ( second afternoon after surgery)

Secondary Outcomes (10)

• Vas score 1

  Within 5 minutes after extubation

• Vas score 2

  postoperative day 1 (POD1) morning

• Vas score 3

  postoperative day 1 (POD1) afternoon

• Vas score 4

  postoperative day 2 (POD2) morning

• Vas score 5

  postoperative day 2 (POD2) afternoon

Other Outcomes (7)

• Depression scale 0

  Before anesthesia induction

• Depression scale 2

  Day 1(the first morning after using PCIA)

• Depression scale 4

  day 2 ( second morning after using PCIA)

Study Arms (2)

Esketamine arm

EXPERIMENTAL

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).

Drug: Esketamine

Sufentanil arm

NO INTERVENTION

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).

Interventions

Esketamine 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).

Esketamine arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing thoracoscopic surgery are required to use PCIA for analgesia;
• ASA grade I-III;
• The patient's age is 18-75 years old; 4、18.5 \< BMI \< 28；
• \. Obtain the informed consent of patients and their families;

You may not qualify if:

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (2)

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

Chongqing, Chongqing Municipality, 400010, China

Location

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (1)

• 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.

  PMID: 38322862 DERIVED

MeSH Terms

Interventions

Esketamine

Study Design

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

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 14, 2022
• Study Start: July 7, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 28, 2023
• Last Updated: August 16, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within one year

Locations

CN (2)