General AnesthesiaNCT06310785
Esketamine Anesthesia in Thoracic Surgery
A study testing Esketamine and Sufentanil in people with General Anesthesia and Thoracic Surgery, run by Hui Xu at 1 site in China.
Trial summary
Patients in the esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Patients in the opioid group was induced with sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium 0.9 mg/kg. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- General Anesthesia, Thoracic Surgery
- What is being tested?
- Esketamine and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2024to 4 Nov 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II
- age 18-70 years
- thoracoscopic segmentectomy or lobectomy is proposed under general anesthesia due to pulmonary nodule
- informed consent was obtained Exclusion Criteria
- body mass index ˃30 kg/m2 or ˂ 19 kg/m2 (2) preoperative use of opioids, acute and chronic pain or hyperalgesia (3) significant ischemic heart disease, including preoperative coronary artery disease, severe angina, heart failure, or structural heart disease (e.g., significant valvular disease) (4) severe hepatic and renal failure before operation (5) history of mental illness or alcoholism (6) history of alcohol or drug abuse (7) increased intracranial pressure, elevated intraocular pressure, or a diagnosis of glaucoma (8) poorly controlled or untreated hypertension (9) preeclampsia or eclampsia (10) untreated and undertreated hyperthyroidism (11) inability to complete the required rating scales
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid-Free Anesthesia Utilizing Esketamine for Thoracoscopic Pulmonary Nodule Surgery: A Randomized Controlled Clinical Trial
Patients in the esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Patients in the opioid group was induced with sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/ kg/h and remifentanil 0.1 ug/kg/min.
Read the detailed description
Before anesthesia induction, radial artery puncture and catheterization under local anesthesia for manometry, and intravenous dexmedetomidine (1 µg/kg) infused over 15 minutes, followed by penehyclidine hydrochloride (0.01mg/kg), palonosetron (0.075 mg), dexamethasone (5 mg). Anesthesia-induced in the opioid group (group A) was intravenous sufentanil 0.5 ug/kg, and esketamine group (group E) received intravenous esketamine 0.5 mg/kg. Subsequently, both groups were sequentially injected with propofol 2 mg/kg and rocuronium 0.9 mg/kg. After the onset of rocuronium, the left-sided double-lumen endotracheal tube was guided by a video laryngoscope, the correct position of the tube was confirmed by bronchoscope, and the anesthesia machine was connected to the tube for mechanical ventilation after fixation, with a tidal volume of 6-8 mL/kg (ideal body weight), a respiratory rate of 10~18 breaths/min, and end-expiratory carbon dioxide partial pressure at 35~45 mmHg (4.7-6.0 kPa).
Intraoperative anesthesia maintenance in the opioid group was pumped with propofol (5 mg/ kg/h) and remifentanil (0.1 ug/kg/h), and esketamine group was pumped with propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h). Rocuronium was administered as needed in intermittent boluses of 0.3 mg/kg intraoperatively. After the lateral decubitus position is set up and the paravertebral block (T4 and T6 levels, 0.5% ropivacaine, 10 ml each) was performed under ultrasound guidance, supplemented by 0.75% ropivacaine infiltration at the surgical site upon skin closure. At the completion of the surgery, patients were given 200 mg sugammadex sodium as an antagonistic residual muscle relaxant. They were transferred to the post-anesthesia care unit (PACU) after tracheal extubation and full recovery of consciousness, and returned to the thoracic surgery ward for further treatment after reaching the discharge criteria of PACU. Postoperative analgesia was provided without patient-controlled intravenous analgesia (PCIA). We employed a modified Brice questionnaire to assess the occurrence of intraoperative awareness. The confusion assessment method (CAM) was used to assess postoperative delirium (POD). Rescue analgesia with intravenous flurbiprofen axetil (50 mg) was administered when NRS scores reached ≥4. Rescue antiemetic therapy (intravenous palonosetron 0.075 mg) was provided for postoperative nausea and vomiting (PONV) scores reached ≥4.
Update note (2026-01-04): The record was updated to correct terminology/wording errors (e.g., static vs dynamic compliance; increased intracranial pressure vs intracranial pressure) and to clarify that PCIA was not used. Meanwhlie, a more detailed account that specifies the anesthetic management protocol with greater precision was provided. One prespecified secondary outcome (inflammatory biomarkers) was not collected; therefore, no data are available for that outcome.
- Conditions
- General Anesthesia, Thoracic Surgery
- Being tested
- Esketamine, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
The esketamine group used esketamine as an analgesic during induction and maintenance of anesthesia.
SufentanilDrug
In the opioid group, sufentanil was used as an analgesic during anesthesia induction and remifentanil was used as an analgesic during anesthesia maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine group | Experimental | Patients in the esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h Receives: Drug: Esketamine |
| opioid group | Active comparator | Patients in the opioid group was induced with sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 0.1 ug/kg/min Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Lung Compliance
Respiratory parameters displayed on the anesthesia ventilator were recorded during one-lung ventilation. The formula: static lung compliance = tidal volume/platform pressure (Pplat) - positive end expiratory pressure (PEEP) was used to calculate the compliance of the ventilate lung.
Measured: During the operation (at 30 minutes of one-lung ventilation).
Secondary outcomes (10)
Static lung compliance during operation
Respiratory parameters displayed on the anesthesia ventilator were recorded. Static lung compliance during operation was calculated as: tidal volume / (Pplat - PEEP).
Measured: At the beginning of double lung ventilation, start of one-lung ventilation, and end of surgery.
Perioperative pulmonary function
Pulmonary function was measured with a portable spirometer, recording forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the FEV1/FVC ratio.
Measured: The day before surgery, one day after surgery, two days after surgery, three days after surgery
Blood pressure
Invasive arterial pressure from the monitor.
Measured: At admission, immediately before intubation, immediately after intubation, at the beginning of double lung ventilation, start of one-lung ventilation, 30 min after the start of one-lung ventilation, end of surgery, and on transfer from the PACU.
Heart rate
Heart rate from the monitor.
Measured: At admission, immediately before intubation, immediately after intubation, at the beginning of double lung ventilation, start of one-lung ventilation, 30 min after the start of one-lung ventilation, end of surgery, and on transfer from the PACU.
Blood gas analysis results
The patient's arterial blood was collected, and the blood gas analyzer was used to determine the human blood H+ concentration and the gas dissolved in the blood (mainly CO2 and O2) to understand the human respiratory function and acid-base balance.
Measured: At admission, at the beginning of double lung ventilation, one-lung ventilation for 30 minutes, end of surgery, and transfer from the PACU.
Serum inflammatory factor levels
This secondary outcome was prespecified. However, no perioperative blood samples were collected for inflammatory biomarkers (e.g., IL-6, IL-8, TNF-α) in this completed study; therefore, no data are available for this outcome.
Measured: not collected
cognitive function
Mini-mental State Examination (MMSE) was used to evaluate the cognitive function of the patients. The total score of the scale was 30, with the lowest score being 0 and the highest 30. A normal person's MMSE score is usually between 27 and 30 points. If the score is lower than 27, it is necessary to be alert to the existence of cognitive impairment. At the same time, according to different levels of education, the classification criteria are also different. For example, illiteracy below 17 points, primary school education below 20 points, secondary school education below 22 points, college education below 23 points, are considered to have cognitive impairment.
Measured: The day before surgery, one day after surgery, three days after surgery
Postoperative nausea and vomiting
Postoperative nausea and vomiting were evaluated using the "Nausea and Vomiting Numerical Rating Scale", the lowest score being 0 and the highest 10, 0 was no nausea; 1-3 is classified as mild nausea; 4-6 classified as moderate nausea; In addition, regardless of the degree of nausea, patients should also record whether they are accompanied by vomiting. If they are accompanied by vomiting, select Yes; Not accompanied by vomiting, Select No.
Measured: 30 min after surgery, 6 h after surgery, 24 h after surgery, and 48 h after surgery
Depression and anxiety
Psychological distress was assessed using the Hospital Anxiety and Depression Scale. Scores of 0-7 on each subscale are classified as "normal", 8-10 as "borderline", and 11-21 as "abnormal" (indicating probable clinical significance).
Measured: The day before surgery, two days after surgery
Postoperative pain
The patients' postoperative pain was evaluated using the "Pain Numerical Rating Scale", the lowest score was 0, the highest score was 10, 0 indicates no pain; A 10 is the worst pain imaginable. A score of 1 to 3 indicates mild pain that does not affect sleep; A score of 4 to 6 indicates moderate pain and disturbed sleep. A score of 7 to 10 indicates severe pain that severely interferes with sleep.
Measured: 30 min after surgery, 6 h after surgery, 24 h after surgery, and 48 h 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 Mar 2024
- Study start4 Feb 2024
- Primary completion31 Oct 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Xu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310785
- Sponsor's protocol ID
- TJ-IRB20231191
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Free Anesthesia Utilizing Esketamine for Thoracoscopic Pulmonary Nodule Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06310785
- Acronym / sponsor ID
- TJ-IRB20231191
- Conditions
- General Anesthesia, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hui XuUniversity, hospital or other
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 15 Mar 2024 (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.
Patients in the esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Patients in the opioid group was induced with sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/ kg/h and remifentanil 0.1 ug/kg/min.
Detailed description
Before anesthesia induction, radial artery puncture and catheterization under local anesthesia for manometry, and intravenous dexmedetomidine (1 µg/kg) infused over 15 minutes, followed by penehyclidine hydrochloride (0.01mg/kg), palonosetron (0.075 mg), dexamethasone (5 mg). Anesthesia-induced in the opioid group (group A) was intravenous sufentanil 0.5 ug/kg, and esketamine group (group E) received intravenous esketamine 0.5 mg/kg. Subsequently, both groups were sequentially injected with propofol 2 mg/kg and rocuronium 0.9 mg/kg. After the onset of rocuronium, the left-sided double-lumen endotracheal tube was guided by a video laryngoscope, the correct position of the tube was confirmed by bronchoscope, and the anesthesia machine was connected to the tube for mechanical ventilation after fixation, with a tidal volume of 6-8 mL/kg (ideal body weight), a respiratory rate of 10~18 breaths/min, and end-expiratory carbon dioxide partial pressure at 35~45 mmHg (4.7-6.0 kPa).
Intraoperative anesthesia maintenance in the opioid group was pumped with propofol (5 mg/ kg/h) and remifentanil (0.1 ug/kg/h), and esketamine group was pumped with propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h). Rocuronium was administered as needed in intermittent boluses of 0.3 mg/kg intraoperatively. After the lateral decubitus position is set up and the paravertebral block (T4 and T6 levels, 0.5% ropivacaine, 10 ml each) was performed under ultrasound guidance, supplemented by 0.75% ropivacaine infiltration at the surgical site upon skin closure. At the completion of the surgery, patients were given 200 mg sugammadex sodium as an antagonistic residual muscle relaxant. They were transferred to the post-anesthesia care unit (PACU) after tracheal extubation and full recovery of consciousness, and returned to the thoracic surgery ward for further treatment after reaching the discharge criteria of PACU. Postoperative analgesia was provided without patient-controlled intravenous analgesia (PCIA). We employed a modified Brice questionnaire to assess the occurrence of intraoperative awareness. The confusion assessment method (CAM) was used to assess postoperative delirium (POD). Rescue analgesia with intravenous flurbiprofen axetil (50 mg) was administered when NRS scores reached ≥4. Rescue antiemetic therapy (intravenous palonosetron 0.075 mg) was provided for postoperative nausea and vomiting (PONV) scores reached ≥4.
Update note (2026-01-04): The record was updated to correct terminology/wording errors (e.g., static vs dynamic compliance; increased intracranial pressure vs intracranial pressure) and to clarify that PCIA was not used. Meanwhlie, a more detailed account that specifies the anesthetic management protocol with greater precision was provided. One prespecified secondary outcome (inflammatory biomarkers) was not collected; therefore, no data are available for that outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine group | Experimental | Drug: EsketaminePatients in the esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h |
| opioid group | Active comparator | Drug: SufentanilPatients in the opioid group was induced with sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 0.1 ug/kg/min |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA physical status I-II
- age 18-70 years
- thoracoscopic segmentectomy or lobectomy is proposed under general anesthesia due to pulmonary nodule
- informed consent was obtained Exclusion Criteria
- body mass index ˃30 kg/m2 or ˂ 19 kg/m2 (2) preoperative use of opioids, acute and chronic pain or hyperalgesia (3) significant ischemic heart disease, including preoperative coronary artery disease, severe angina, heart failure, or structural heart disease (e.g., significant valvular disease) (4) severe hepatic and renal failure before operation (5) history of mental illness or alcoholism (6) history of alcohol or drug abuse (7) increased intracranial pressure, elevated intraocular pressure, or a diagnosis of glaucoma (8) poorly controlled or untreated hypertension (9) preeclampsia or eclampsia (10) untreated and undertreated hyperthyroidism (11) inability to complete the required rating scales
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EsketamineThe esketamine group used esketamine as an analgesic during induction and maintenance of anesthesia. | Drug | Esketamine group |
| SufentanilIn the opioid group, sufentanil was used as an analgesic during anesthesia induction and remifentanil was used as an analgesic during anesthesia maintenance. | Drug | opioid group |
Primary outcome
Static Lung Compliance
Time frame: During the operation (at 30 minutes of one-lung ventilation).
Respiratory parameters displayed on the anesthesia ventilator were recorded during one-lung ventilation. The formula: static lung compliance = tidal volume/platform pressure (Pplat) - positive end expiratory pressure (PEEP) was used to calculate the compliance of the ventilate lung.
10 secondary outcomes
Static lung compliance during operation
Time frame: At the beginning of double lung ventilation, start of one-lung ventilation, and end of surgery.
Perioperative pulmonary function
Time frame: The day before surgery, one day after surgery, two days after surgery, three days after surgery
Blood pressure
Time frame: At admission, immediately before intubation, immediately after intubation, at the beginning of double lung ventilation, start of one-lung ventilation, 30 min after the start of one-lung ventilation, end of surgery, and on transfer from the PACU.
Heart rate
Time frame: At admission, immediately before intubation, immediately after intubation, at the beginning of double lung ventilation, start of one-lung ventilation, 30 min after the start of one-lung ventilation, end of surgery, and on transfer from the PACU.
Blood gas analysis results
Time frame: At admission, at the beginning of double lung ventilation, one-lung ventilation for 30 minutes, end of surgery, and transfer from the PACU.
Serum inflammatory factor levels
Time frame: not collected
cognitive function
Time frame: The day before surgery, one day after surgery, three days after surgery
Postoperative nausea and vomiting
Time frame: 30 min after surgery, 6 h after surgery, 24 h after surgery, and 48 h after surgery
Depression and anxiety
Time frame: The day before surgery, two days after surgery
Postoperative pain
Time frame: 30 min after surgery, 6 h after surgery, 24 h after surgery, and 48 h 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 17 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and Sufentanil in people with General Anesthesia and Thoracic Surgery, run by Hui Xu 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 5 inclusion and 0 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 17 Jun 2026. 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. 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?
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?
Static Lung Compliance (time frame: During the operation (at 30 minutes of one-lung ventilation).). 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 17 Jun 2026.