Clinical trial NCT05458453: An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery
Official title: An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esketamine
Thoracoscopic Surgery
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Minute ventilation volume 0
timeFrame: Before anesthesia induction
measure: Minute ventilation volume 1
timeFrame: Within 5 minutes after extubation
measure: Minute ventilation volume 2
timeFrame: postoperative day 1 (POD1) morning
measure: Minute ventilation volume 3
timeFrame: postoperative day 1 (POD1) afternoon
measure: Minute ventilation volume 4
timeFrame: postoperative day 2 (POD2) morning
measure: Minute ventilation volume 5
timeFrame: postoperative day 2 (POD2) afternoon
measure: Tidal volume 0
timeFrame: Before anesthesia induction
measure: Tidal volume 1
timeFrame: Within 5 minutes after extubation
measure: Tidal volume 2
timeFrame: Day1 （The first morning after surgery）
measure: Tidal volume 3
timeFrame: Day1（The afternoon of the first day after surgery）
measure: Tidal volume 4
timeFrame: day 2 ( second morning after surgery)
measure: Tidal volume 5
timeFrame: day 2 ( second afternoon after surgery)
measure: Respiratory rate 0
timeFrame: Before anesthesia induction
measure: Respiratory rate 1
timeFrame: Within 5 minutes after extubation
measure: Respiratory rate 2
timeFrame: Day1 （The first morning after surgery）
measure: Respiratory rate 3
timeFrame: Day1 （The afternoon of the first day after surgery）
measure: Respiratory rate 4
timeFrame: day 2 ( second morning after using surgery)
measure: Respiratory rate 5
timeFrame: day 2 ( second afternoon after surgery)
Secondary outcomes:
measure: Vas score 1
timeFrame: Within 5 minutes after extubation
measure: Vas score 2
timeFrame: postoperative day 1 (POD1) morning
measure: Vas score 3
timeFrame: postoperative day 1 (POD1) afternoon
measure: Vas score 4
timeFrame: postoperative day 2 (POD2) morning
measure: Vas score 5
timeFrame: postoperative day 2 (POD2) afternoon
measure: Oxygenation index 0
timeFrame: Before anesthesia induction
measure: Oxygenation index 1
timeFrame: Within 5 minutes after extubation
measure: Oxygenation index 3
timeFrame: postoperative Day 1
measure: Incidence of postoperative pulmonary complications during hospitalization
timeFrame: From end of the surgery to hospital discharge with about mean of 7 days after surgery
measure: incidence of hypoxemia during the first and second day after surgery
timeFrame: from end of the surgery to the second day after surgery
Other outcomes:
measure: Depression scale 0
timeFrame: Before anesthesia induction
measure: Depression scale 2
timeFrame: Day 1(the first morning after using PCIA)
measure: Depression scale 4
timeFrame: day 2 ( second morning after using PCIA)
measure: anxiety score 0
timeFrame: Before anesthesia induction
measure: anxiety score 2
timeFrame: Day1(the first morning after using PCIA)
measure: anxiety score 4
timeFrame: day 2 ( second morning after using PCIA)
measure: sleep quality during the first two days after surgery
timeFrame: from end of the surgery to the second day after surgery
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
References: