Esketamine Plus Dexmedetomidine Affect Postoperative QualityNCT07125573
The Effect of Esketamine Combined With Dexmedetomidine on Postoperative Recovery Quality in Patients Undergoing Thoracoscopic Surgery
A study testing Saline Solution (NaCl 0,9%), Low-dose esketamine infusion and High-dose esketamine infusion in people with Esketamine Plus Dexmedetomidine Affect Postoperative Quality and Thoracoscopy, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
Brief Summary：Video-assisted thoracoscopic surgery (VATS) has a wide range of applications, including the diagnosis and treatment of lung cancer, and has gradually replaced traditional open thoracotomy. VATS must routinely employ single-lung ventilation techniques. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esketamine Plus Dexmedetomidine Affect Postoperative Quality, Thoracoscopy, Lung Neoplasms
- What is being tested?
- Saline Solution (NaCl 0,9%), Low-dose esketamine infusion and High-dose esketamine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old;
- BMI 18-30 kg/m2;
- ASA classification I-III;
- Patients undergoing thoracoscopic surgery;
- No contraindications to the study drug;
- Ability to express, communicate, and understand normally;
- Both the patient and their family members agree to participate in this study and sign the informed consent form.
Who cannot join
- Patients with poorly controlled or untreated hypertension;
- Patients with untreated hyperthyroidism;
- Patients with mental illness, cognitive impairment, or language barriers that prevent communication;
- Patients with severe cardiopulmonary, hepatic, or renal dysfunction;
- Patients with increased intracranial pressure;
- Patients with a history of allergic reactions to any of the drugs used in the study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 6500000
About this study
Brief Summary：Video-assisted thoracoscopic surgery (VATS) has a wide range of applications, including the diagnosis and treatment of lung cancer, and has gradually replaced traditional open thoracotomy. VATS must routinely employ single-lung ventilation techniques. During single-lung ventilation, mechanical injury, lung collapse, imbalance in the ventilation-perfusion ratio, ischemia-reperfusion, and other pathological physiological changes may occur, leading to the release of a large number of inflammatory factors, triggering local and systemic inflammatory responses,increasing the incidence of postoperative complications, and affecting patient outcomes. Additionally, most patients undergoing thoracoscopic surgery experience acute postoperative pain. If acute postoperative pain is not adequately controlled, it may progress to chronic pain, affecting the quality of postoperative recovery. Currently, opioid medications are the primary drugs used to treat moderate to severe postoperative pain. However, adverse events associated with opioid medications may also affect the quality of postoperative recovery.The use of multimodal analgesia for postoperative pain management can control pain and reduce the need for opioid medications.
Esketamine, a newly marketed intravenous anesthetic in China in recent years, is the dextrorotatory isomer of ketamine, and acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor. Compared to ketamine, esketamine has higher potency, faster recovery time, and fewer adverse effects. Some clinical studies have shown that administration of esketamine reduces the intensity of postoperative pain and decreases the need for postoperative analgesics. Research has found that esketamine reduces the consumption of opioid medications and hyperalgesia postoperatively. Additionally, studies have shown that esketamine administration improves recovery quality by alleviating postoperative pain. Dexmedetomidine (DEX) is a selectiveα2 adrenergic receptor agonist with sedative and analgesic effects. Studies have shown that dexmedetomidine effectively reduces surgical inflammation, oxidative stress, and postoperative pain, thereby promoting postoperative recovery in surgical patients without increasing the risk of adverse reactions or complications. A meta-analysis indicated that dexmedetomidine administration alleviates postoperative pain and reduces postoperative nausea and vomiting (PONV). Current evidence suggests that the use of dexmedetomidine improves postoperative recovery quality. However, the effects of esketamine combined with dexmedetomidine on postoperative recovery quality in patients undergoing thoracoscopic surgery have not been reported. This study aims to investigate whether the combined administration of esketamine and dexmedetomidine can further improve postoperative recovery quality in patients undergoing thoracoscopic surgery.
- Conditions
- Esketamine Plus Dexmedetomidine Affect Postoperative Quality, Thoracoscopy, Lung Neoplasms
- Being tested
- Saline Solution (NaCl 0,9%), Low-dose esketamine infusion, High-dose esketamine infusion
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Solution (NaCl 0,9%)Drug
Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery,Administer saline solution one minute after induction of anesthesia and continue until 30 minutes before the end of surgery.
Low-dose esketamine infusionDrug
Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, administer esketamine 0.2 mg/kg 1 minute after induction of anesthesia, maintain at 2 μg/kg/min after intubation until 30 minutes before the end of surgery.
High-dose esketamine infusionDrug
Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, Administer 0.2 mg/kg of esketamine 1 minute after induction of anesthesia, and maintain at 4 μg/kg/min after intubation until 30 minutes before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Saline solution + dexmedetomidine group | Placebo comparator | Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery,Administer saline solution one minute after induction of anesthesia and continue until 30 minutes before the end of surgery. Receives: Drug: Saline Solution (NaCl 0,9%) |
| Low-dose esketamine + dexmedetomidine group | Experimental | Administer dexmedetomidine 0.5 μg/kg 10 minutes before surgery, maintain at 0.4 μg/kg/h after intubation until 30 minutes before the end of surgery, administer esketamine 0.2 mg/kg 1 minute after induction of anesthesia, maintain at 2 μg/kg/min after intubation until 30 minutes before the end of surgery. Receives: Drug: Low-dose esketamine infusion |
| High-dose esketamine + dexmedetomidine group | Experimental | Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, Administer 0.2 mg/kg of esketamine 1 minute after induction of anesthesia, and maintain at 4 μg/kg/min after intubation until 30 minutes before the end of surgery. Receives: Drug: High-dose esketamine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery.
Measured: Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third 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 posted15 Aug 2025
- Study start1 May 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esketamine Plus Dexmedetomidine Affect Postoperative QualityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinqiao Qian, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125573
- Sponsor's protocol ID
- (2025) Ethical Review L No. 81
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esketamine Combined With Dexmedetomidine on Postoperative Recovery Quality in Patients Undergoing Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT07125573
- Acronym / sponsor ID
- (2025) Ethical Review L No. 81
- Conditions
- Esketamine Plus Dexmedetomidine Affect Postoperative Quality, Thoracoscopy, Lung Neoplasms
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Aug 2025 (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.
Brief Summary：Video-assisted thoracoscopic surgery (VATS) has a wide range of applications, including the diagnosis and treatment of lung cancer, and has gradually replaced traditional open thoracotomy. VATS must routinely employ single-lung ventilation techniques. During single-lung ventilation, mechanical injury, lung collapse, imbalance in the ventilation-perfusion ratio, ischemia-reperfusion, and other pathological physiological changes may occur, leading to the release of a large number of inflammatory factors, triggering local and systemic inflammatory responses,increasing the incidence of postoperative complications, and affecting patient outcomes. Additionally, most patients undergoing thoracoscopic surgery experience acute postoperative pain. If acute postoperative pain is not adequately controlled, it may progress to chronic pain, affecting the quality of postoperative recovery. Currently, opioid medications are the primary drugs used to treat moderate to severe postoperative pain. However, adverse events associated with opioid medications may also affect the quality of postoperative recovery.The use of multimodal analgesia for postoperative pain management can control pain and reduce the need for opioid medications.
Esketamine, a newly marketed intravenous anesthetic in China in recent years, is the dextrorotatory isomer of ketamine, and acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor. Compared to ketamine, esketamine has higher potency, faster recovery time, and fewer adverse effects. Some clinical studies have shown that administration of esketamine reduces the intensity of postoperative pain and decreases the need for postoperative analgesics. Research has found that esketamine reduces the consumption of opioid medications and hyperalgesia postoperatively. Additionally, studies have shown that esketamine administration improves recovery quality by alleviating postoperative pain. Dexmedetomidine (DEX) is a selectiveα2 adrenergic receptor agonist with sedative and analgesic effects. Studies have shown that dexmedetomidine effectively reduces surgical inflammation, oxidative stress, and postoperative pain, thereby promoting postoperative recovery in surgical patients without increasing the risk of adverse reactions or complications. A meta-analysis indicated that dexmedetomidine administration alleviates postoperative pain and reduces postoperative nausea and vomiting (PONV). Current evidence suggests that the use of dexmedetomidine improves postoperative recovery quality. However, the effects of esketamine combined with dexmedetomidine on postoperative recovery quality in patients undergoing thoracoscopic surgery have not been reported. This study aims to investigate whether the combined administration of esketamine and dexmedetomidine can further improve postoperative recovery quality in patients undergoing 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline solution + dexmedetomidine group | Placebo comparator | Drug: Saline Solution (NaCl 0,9%)Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery,Administer saline solution one minute after induction of anesthesia and continue until 30 minutes before the end of surgery. |
| Low-dose esketamine + dexmedetomidine group | Experimental | Drug: Low-dose esketamine infusionAdminister dexmedetomidine 0.5 μg/kg 10 minutes before surgery, maintain at 0.4 μg/kg/h after intubation until 30 minutes before the end of surgery, administer esketamine 0.2 mg/kg 1 minute after induction of anesthesia, maintain at 2 μg/kg/min after intubation until 30 minutes before the end of surgery. |
| High-dose esketamine + dexmedetomidine group | Experimental | Drug: High-dose esketamine infusionAdminister 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, Administer 0.2 mg/kg of esketamine 1 minute after induction of anesthesia, and maintain at 4 μg/kg/min after intubation until 30 minutes before the end of surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-65 years old;
- BMI 18-30 kg/m2;
- ASA classification I-III;
- Patients undergoing thoracoscopic surgery;
- No contraindications to the study drug;
Key exclusion criteria (6 listed)
- Patients with poorly controlled or untreated hypertension;
- Patients with untreated hyperthyroidism;
- Patients with mental illness, cognitive impairment, or language barriers that prevent communication;
- Patients with severe cardiopulmonary, hepatic, or renal dysfunction;
- Patients with increased intracranial pressure;
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 |
|---|---|---|
| Saline Solution (NaCl 0,9%)Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery,Administer saline solution one minute after induction of anesthesia and continue until 30 minutes before the end of surgery. | Drug | Saline solution + dexmedetomidine group |
| Low-dose esketamine infusionAdminister 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, administer esketamine 0.2 mg/kg 1 minute after induction of anesthesia, maintain at 2 μg/kg/min after intubation until 30 minutes before the end of surgery. | Drug | Low-dose esketamine + dexmedetomidine group |
| High-dose esketamine infusionAdminister 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, Administer 0.2 mg/kg of esketamine 1 minute after induction of anesthesia, and maintain at 4 μg/kg/min after intubation until 30 minutes before the end of surgery. | Drug | High-dose esketamine + dexmedetomidine group |
Primary outcome
Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery.
Time frame: Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Solution (NaCl 0,9%), Low-dose esketamine infusion and High-dose esketamine infusion in people with Esketamine Plus Dexmedetomidine Affect Postoperative Quality and Thoracoscopy, run by First Affiliated Hospital of Kunming Medical University at 1 site 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 7 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery. (time frame: Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.