EsketaminePhase 4NCT05458453
An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery
A Phase 4 study testing Esketamine in people with Esketamine and Thoracoscopic Surgery, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esketamine, Thoracoscopic Surgery
- What is being tested?
- Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 7 Jul 2022to 28 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
- 5. Obtain the informed consent of patients and their families;
Who cannot join
- 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;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
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
- Being tested
- Esketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute ventilation volume 0
Minute ventilation volume before anesthesia induction
Measured: Before anesthesia induction
Minute ventilation volume 1
Minute ventilation volume after extubation
Measured: Within 5 minutes after extubation
Minute ventilation volume 2
Minute ventilation volume on the first morning
Measured: postoperative day 1 (POD1) morning
Minute ventilation volume 3
Minute ventilation volume on the first afternoon
Measured: postoperative day 1 (POD1) afternoon
Minute ventilation volume 4
Minute ventilation volume on the next morning
Measured: postoperative day 2 (POD2) morning
Minute ventilation volume 5
Minute ventilation volume on the next afternoon
Measured: postoperative day 2 (POD2) afternoon
Tidal volume 0
Tidal volume before anesthesia induction
Measured: Before anesthesia induction
Tidal volume 1
Tidal volume after extubation
Measured: Within 5 minutes after extubation
Tidal volume 2
Tidal volume on the first morning after surgery
Measured: Day1 （The first morning after surgery）
Tidal volume 3
Tidal volume on the first afternoon after surgery
Measured: Day1（The afternoon of the first day after surgery）
Tidal volume 4
Tidal volume on the next morning after surgery
Measured: day 2 ( second morning after surgery)
Tidal volume 5
Tidal volume on the next afternoon after surgery
Measured: day 2 ( second afternoon after surgery)
Respiratory rate 0
Respiratory rate before anesthesia induction
Measured: Before anesthesia induction
Respiratory rate 1
Respiratory rate after extubation
Measured: Within 5 minutes after extubation
Respiratory rate 2
Respiratory rate on the first morning after surgery
Measured: Day1 （The first morning after surgery）
Respiratory rate 3
Respiratory rate on the first afternoon after surgery
Measured: Day1 （The afternoon of the first day after surgery）
Respiratory rate 4
Respiratory rate on the next morning after surgery
Measured: day 2 ( second morning after using surgery)
Respiratory rate 5
Respiratory rate on the next afternoon after surgery
Measured: day 2 ( second afternoon after surgery)
Secondary outcomes (10)
Vas score 1
The higher the score, the more painful it is.
Measured: Within 5 minutes after extubation
Vas score 2
The higher the score, the more painful it is.
Measured: postoperative day 1 (POD1) morning
Vas score 3
The higher the score, the more painful it is.
Measured: postoperative day 1 (POD1) afternoon
Vas score 4
The higher the score, the more painful it is.
Measured: postoperative day 2 (POD2) morning
Vas score 5
The higher the score, the more painful it is.
Measured: postoperative day 2 (POD2) afternoon
Oxygenation index 0
Oxygenation index (calculated as PaO2/FiO2) before anesthesia induction
Measured: Before anesthesia induction
Oxygenation index 1
Oxygenation index (calculated as PaO2/FiO2) after extubation
Measured: Within 5 minutes after extubation
Oxygenation index 3
Oxygenation index (calculated as PaO2/FiO2) on the first morning
Measured: postoperative Day 1
Incidence of postoperative pulmonary complications during hospitalization
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.
Measured: From end of the surgery to hospital discharge with about mean of 7 days after surgery
incidence of hypoxemia during the first and second day after surgery
hypoxemia is defined as SpO2<92% during the first and second day after surgery
Measured: from end of the surgery to the second day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start7 Jul 2022
- Primary completion20 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EsketamineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458453
- Sponsor's protocol ID
- Esketamine and thoracoscopic
- Status last verified
- Aug 2022
- First submitted
- 1 Jul 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Publications
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.
PubMed 38322862
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Esketamine in Patients After Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05458453
- Acronym / sponsor ID
- Esketamine and thoracoscopic
- Conditions
- Esketamine, Thoracoscopic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine arm | Experimental | Drug: EsketamineSelf-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). |
| 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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；
- 5. Obtain the informed consent of patients and their families;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineSelf-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). | Drug | Esketamine arm |
Primary outcome
Minute ventilation volume 0
Time frame: Before anesthesia induction
Minute ventilation volume before anesthesia induction
Minute ventilation volume 1
Time frame: Within 5 minutes after extubation
Minute ventilation volume after extubation
Minute ventilation volume 2
Time frame: postoperative day 1 (POD1) morning
Minute ventilation volume on the first morning
Minute ventilation volume 3
Time frame: postoperative day 1 (POD1) afternoon
Minute ventilation volume on the first afternoon
Minute ventilation volume 4
Time frame: postoperative day 2 (POD2) morning
Minute ventilation volume on the next morning
Minute ventilation volume 5
Time frame: postoperative day 2 (POD2) afternoon
Minute ventilation volume on the next afternoon
Tidal volume 0
Time frame: Before anesthesia induction
Tidal volume before anesthesia induction
Tidal volume 1
Time frame: Within 5 minutes after extubation
Tidal volume after extubation
Tidal volume 2
Time frame: Day1 （The first morning after surgery）
Tidal volume on the first morning after surgery
Tidal volume 3
Time frame: Day1（The afternoon of the first day after surgery）
Tidal volume on the first afternoon after surgery
Tidal volume 4
Time frame: day 2 ( second morning after surgery)
Tidal volume on the next morning after surgery
Tidal volume 5
Time frame: day 2 ( second afternoon after surgery)
Tidal volume on the next afternoon after surgery
Respiratory rate 0
Time frame: Before anesthesia induction
Respiratory rate before anesthesia induction
Respiratory rate 1
Time frame: Within 5 minutes after extubation
Respiratory rate after extubation
Respiratory rate 2
Time frame: Day1 （The first morning after surgery）
Respiratory rate on the first morning after surgery
Respiratory rate 3
Time frame: Day1 （The afternoon of the first day after surgery）
Respiratory rate on the first afternoon after surgery
Respiratory rate 4
Time frame: day 2 ( second morning after using surgery)
Respiratory rate on the next morning after surgery
Respiratory rate 5
Time frame: day 2 ( second afternoon after surgery)
Respiratory rate on the next afternoon after surgery
10 secondary outcomes
Vas score 1
Time frame: Within 5 minutes after extubation
Vas score 2
Time frame: postoperative day 1 (POD1) morning
Vas score 3
Time frame: postoperative day 1 (POD1) afternoon
Vas score 4
Time frame: postoperative day 2 (POD2) morning
Vas score 5
Time frame: postoperative day 2 (POD2) afternoon
Oxygenation index 0
Time frame: Before anesthesia induction
Oxygenation index 1
Time frame: Within 5 minutes after extubation
Oxygenation index 3
Time frame: postoperative Day 1
Incidence of postoperative pulmonary complications during hospitalization
Time frame: From end of the surgery to hospital discharge with about mean of 7 days after surgery
incidence of hypoxemia during the first and second day after surgery
Time frame: from end of the surgery to the second day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Derived from this study: PubMed 38322862Fu 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.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine in people with Esketamine and Thoracoscopic Surgery, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minute ventilation volume 0 (time frame: Before anesthesia induction). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.