Hepatic NeoplasmPhase 1/2NCT07034950
Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation
A Phase 1/2 study testing Intravenous esketamine using Dixon's up-and-down sequential method, Intravenous the dose of esketamine ED95 and Intravenous fentanyl 1 μg∙kg-1 in people with Hepatic Neoplasm and Hepatic Cancer, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
Effective pain management during percutaneous thermal ablation of liver tumors outside the operating room remains a significant challenge. While hepatic hilar nerve block (HHNB) provides partial analgesia, its incomplete efficacy often requires opioid supplementation, potentially increasing perioperative risks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Neoplasm, Hepatic Cancer
- What is being tested?
- Intravenous esketamine using Dixon's up-and-down sequential method, Intravenous the dose of esketamine ED95 and Intravenous fentanyl 1 μg∙kg-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2025to 30 Jun 2028
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 - 80 years;
- ASA physical status Ⅰ or Ⅲ;
- Body mass index (BMI) 18 - 28 kg∙m-2;
- Scheduled for elective ultrasound-guided thermal ablation of solitary liver tumors under HHNB.
Who cannot join
- Pharmacological contraindications:
- Known hypersensitivity to study medications (esketamine, midazolam);
- Opioid or benzodiazepine dependence;
- Using analgesics within the last 24 h preoperatively;
- Participation in other investigational drug trials within 90 days. (ii) Clinical comorbidities and surgery history:
- Multifocal hepatic lesions requiring concurrent ablation;
Show all 15Show fewer
- Patients after liver transplantation;
- Active upper respiratory tract infection within 14 days;
- Severe cardiopulmonary diseases (New York Heart Association [NYHA] class Ⅲ-Ⅳ, FEV1/FVC < 70%);
- Decompensated hepatic insufficiency (Child-Pugh C);
- Uncontrolled hypertension (≥180/110 mmHg), elevated intracranial/intraocular pressure, or hyperthyroidism;
- Major neuropsychiatric disorders (epilepsy, schizophrenia, major depressive disorder, cognitive impairment).
- Procedural Risk Factors:
- Anticipated difficult airway (Mallampati Ⅲ-Ⅳ, thyromental distance < 6 cm) or anatomical airway obstruction;
- Inadequate preoperative fasting (solid intake < 8 hours, clear fluids < 2 hours).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China
Xiamen, Fujian, 361000
About this study
Official title: Study on the Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation Under Hilar Nerve Blockade
Effective pain management during percutaneous thermal ablation of liver tumors outside the operating room remains a significant challenge. While hepatic hilar nerve block (HHNB) provides partial analgesia, its incomplete efficacy often requires opioid supplementation, potentially increasing perioperative risks. Esketamine, an N-methyl-D-aspartate receptor antagonist, exhibits unique dual analgesic-sedative properties that may address this therapeutic gap, thus obviating the necessity for opioids. This prospective dose-finding study aimed to establish the median effective dose (ED50) and 95% effective dose (ED95) of esketamine for opioid-free analgesia during ultrasound-guided thermal ablation of liver tumors under HHNB. Afterwards, the investigators will conduct an RCT study to evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.
Read the detailed description
This research will be divided into two stages.
(i) In Phase one, a prospective dose discovery study using the Dixon sequential method will be conducted, aiming to determine the median effective dose (ED50) and 95% effective dose (ED95) of esketamine during ultrasound-guided thermal ablation of liver tumors under hepatic hilar nerve block (HHNB). Esketamine will be initiated by intravenous drip at 0.3 mg∙kg-1, and then based on the patient's response to pain (positive: body movement or complaint of pain; Negative: No body movement or no reported pain. The dose will be adjusted, with a fluctuation step of 0.02 mg∙kg-1 up and down. All patients will receive a standardized anesthesia regimen, including the administration of midazolam at 0.03 mg∙kg-1 and hepatic portal nerve block (10 ml of 0.5% ropivacaine) under ultrasound guidance. Local anaesthesia will be administered using 10 ml of 1% lidocaine, which will be applied until the liver capsule is reached. The test will continue until six cross-pairings will be obtained. Probabilistic regression analysis will be used to calculate the ED50 and ED95 of esketamine with a 95% confidence interval.
(ii) The investigators will conduct a single-center, randomized, double-blind controlled trial in Phase Two to evaluate the safety of the esketamine ED95 dose under the monitoring anesthesia care program based on the incidence of respiratory depression. The intervention group will be injected with the dose of esketamine ED95; the control group will be first injected with fentanyl at a dose of 1 μg∙kg-1. Both groups of patients will receive the same anesthesia regimen, namely midazolam 0.03 mg∙kg-1, and hepatic portal nerve block (0.5% ropivacaine 10 ml) will be performed under ultrasound guidance. Intravenous injection of 100 mg of flurbiprofen axetil for auxiliary analgesia. Intravenous injection of 4 mg of ondansetron to prevent nausea and vomiting.
- Conditions
- Hepatic Neoplasm, Hepatic Cancer
- Being tested
- Intravenous esketamine using Dixon's up-and-down sequential method, Intravenous the dose of esketamine ED95, Intravenous fentanyl 1 μg∙kg-1
- Keywords
- hepatic hilar nerve block, Ultrasound-guided, Thermal Ablation, Esketamine, Pain
- Medical subject headings
- Liver Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous esketamine using Dixon's up-and-down sequential methodDrug
Also called Ultrasound-guided hepatic hilar nerve block (HHNB), Standardized premedication (midazolam 0.03 mg∙kg-1), Local anaesthesia using 10 ml of 1% lidocaine
Using Dixon's up-and-down sequential method, esketamine will be titrated intravenously from an initial 0.3 mg∙kg-1 dose with 0.02 mg∙kg-1 adjustments based on intraprocedural responses to pain (Positive: purposeful somatic movement or the complaint of pain; Negative: no movement or no complaint of pain). The titration sequence will continue until six crossover inflection points are observed.
Intravenous the dose of esketamine ED95Drug
Also called Ultrasound-guided hepatic hilar nerve block (HHNB), Standardized premedication (midazolam 0.03 mg∙kg-1), Local anaesthesia using 10 ml of 1% lidocaine
The intervention group will be injected with the dose of esketamine ED95.
Intravenous fentanyl 1 μg∙kg-1Drug
Also called Ultrasound-guided hepatic hilar nerve block (HHNB), Standardized premedication (midazolam 0.03 mg∙kg-1), Local anaesthesia using 10 ml of 1% lidocaine
The control group will be injected with fentanyl 1 μg∙kg-1.
| Study group | Role | What they receive |
|---|---|---|
| Determine the ED50 and ED95 of esketamine by Dixon's up-and-down method | Experimental | Using Dixon's up-and-down sequential method, esketamine will be titrated intravenously from an initial 0.3 mg∙kg-1 dose with 0.02 mg∙kg-1 adjustments based on intraprocedural responses to pain (positive: purposeful somatic movement or the complaint of pain; negative: no movement or no complaint of pain). All patients will receive standardized premedication with HHNB. The titration sequence will continue until six crossover inflection points are observed. Receives: Drug: Intravenous esketamine using Dixon's up-and-down sequential method |
| Evaluate the safety of the dose of esketamine ED95 by the incidence of respiratory depression | Active comparator | The intervention group will be injected with the dose of esketamine ED95; the control group will be injected with fentanyl 1 μg∙kg-1. The study at this stage will evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression. Receives: Drug: Intravenous the dose of esketamine ED95; Drug: Intravenous fentanyl 1 μg∙kg-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
thermal ablation-induced somatic responses to pain
Positive: Body movement or complaint of pain. Negative: No body movement or no reported pain. This scale will be administered during the surgery at the first stage of the research.
Measured: Day 1 (During the surgery at the first stage of the research)
Incidence of respiratory depression
By comparing with the control group, evaluate the safety of ED95 of esketamine by the incidence of respiratory depression at T2-T5 of the second stage of the research.
The primary outcome is the incidence of respiratory depression, which is defined as SpO2 <90% or EtCO2 >55 mmHg.
T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors; and T5: In the PACU.
Measured: Day 1 (T2-T5 of the second stage of the research)
Secondary outcomes (14)
HR
HR: heart rate. T1: Prior to anesthesia (10 minutes after positioning); T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors; and T5: In the PACU.
Measured: Day 1 (T1-T5 of the first and second stages of the research)
MAP
MAP: Mean Arterial Pressure. T1: Prior to anesthesia (10 minutes after positioning); T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors; and T5: In the PACU.
Measured: Day 1 (T1-T5 of the first and second stages of the research)
RR
RR: respiratory rate. T1: Prior to anesthesia (10 minutes after positioning); T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors; and T5: In the PACU.
Measured: Day 1 (T1-T5 of the first and second stages of the research)
SPO2
SPO2: peripheral oxygen saturation. T1: Prior to anesthesia (10 minutes after positioning); T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors; and T5: In the PACU.
Measured: Day 1 (T1-T5 of the first and second stages of the research)
EtCO2
EtCO2: End-expiratory carbon dioxide. T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors; and T5: In the PACU.
Measured: Day 1 (T2-T5 of the first and second stages of the research)
Adverse events
Adverse events will encompass a range of systems, including the cardiovascular system (eg. high/low blood pressure and sinus tachycardia/bradycardia), as well as symptoms such as nausea, vomiting, dizziness, and mental symptoms.
T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors; T5: In the PACU.
T6 to T8: 2, 6, and 24 hours after the procedure.
Measured: Day 1 (T2-T8 of the first and second stages of the research)
NRS
The Numeric Rating Scale (NRS) will be utilized to assess postoperative pain, with a range of 0 representing no pain and 10 representing severe pain. This scale will be administered at 2, 6, and 24 hours following the procedure.
T6 to T8: 2, 6, and 24 hours after the procedure.
Measured: Day 1 (T6-T8 of the first and second stages of the research)
The need for remedial analgesia
The consumption of remedial analgesia will be the total consumption of acetaminophen documented at 2, 6, and 24 hours after the procedure.
T6 to T8: 2, 6, and 24 hours after the procedure.
Measured: Day 1 (T6-T8 of the first and second stages of the research)
Success rate of anesthesia
Anesthesia success will be defined as inadequate analgesia requiring ≤3 rescue doses of remifentanil within 10 min throughout the procedure. The success rate of anesthesia will be calculated by dividing the number of successful anesthesia cases by the total number of cases.
T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors
Measured: Day 1 (T2-T4 of the second stage of the research)
Induction duration
Induction duration is defined as the period from the start of anaesthetic drug injection to the commencement of the surgical procedure at the second stage of the research.
Measured: Day 1 of the second stage of the research
Duration of awakening
Duration of awakening is defined as the period from the conclusion of the surgical procedure to the moment of eye-opening.
Measured: Day 1 of the second stage of the research
Duration of stay in the hospital
Duration of stay in the hospital is measured from the moment the patient enters the operating room until the moment they are discharged.
Measured: Day 1 and Day 2 of the second stage of the research
The satisfaction of the sonographer
The satisfaction score of the sonographer will be collected postoperatively on Day 1, using a scale ranging from 0 to 10, with 0 representing dissatisfaction and 10 representing very satisfied.
Measured: Day 1 of the second stage of the research
The satisfaction of patients
The satisfaction of patients will be collected postoperatively on Day 2, using a scale ranging from 0 to 10, with 0 representing dissatisfaction and 10 representing very satisfied.
Measured: Day 2 of the second stage of the research
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start29 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic NeoplasmStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This research will be divided into two stages. (i) In Phase one, a prospective dose discovery study using the Dixon sequential method will be conducted, aiming to determine the median effective dose (ED50) and 95% effective dose (ED95) of esketamine during ultrasound-guided hepatic tumor thermal ablation under hilar nerve block (HHNB). The sample size is approximately 27. (ii) The investigators will conduct a single-center, randomized, double-blind controlled trial in Phase Two to evaluate the safety of the esketamine ED95 dose under the monitoring anesthesia care program based on the incidence of respiratory depression. The intervention group will be injected with the dose of esketamine ED95; the control group will be injected with fentanyl 1 μg∙kg-1. Both groups of patients will receive the same sedation regimen. The sample size is approximately 52.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lijuan Yan, The First Affiliated Hospital of Xiamen University
- Investigators
- Lijuan Yan, Principal investigator, Department of Anesthesiology, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034950
- Sponsor's protocol ID
- XMFHIIT-2025SL091
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 11 Sep 2025
- Results posted
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation Under Hilar Nerve Blockade
- ClinicalTrials.gov ID
- NCT07034950
- Acronym / sponsor ID
- XMFHIIT-2025SL091
- Conditions
- Hepatic Neoplasm, Hepatic Cancer
- Keywords
- hepatic hilar nerve block, Ultrasound-guided, Thermal Ablation, Esketamine, Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 29 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Jun 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.
Effective pain management during percutaneous thermal ablation of liver tumors outside the operating room remains a significant challenge. While hepatic hilar nerve block (HHNB) provides partial analgesia, its incomplete efficacy often requires opioid supplementation, potentially increasing perioperative risks. Esketamine, an N-methyl-D-aspartate receptor antagonist, exhibits unique dual analgesic-sedative properties that may address this therapeutic gap, thus obviating the necessity for opioids. This prospective dose-finding study aimed to establish the median effective dose (ED50) and 95% effective dose (ED95) of esketamine for opioid-free analgesia during ultrasound-guided thermal ablation of liver tumors under HHNB. Afterwards, the investigators will conduct an RCT study to evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.
Detailed description
This research will be divided into two stages.
(i) In Phase one, a prospective dose discovery study using the Dixon sequential method will be conducted, aiming to determine the median effective dose (ED50) and 95% effective dose (ED95) of esketamine during ultrasound-guided thermal ablation of liver tumors under hepatic hilar nerve block (HHNB). Esketamine will be initiated by intravenous drip at 0.3 mg∙kg-1, and then based on the patient's response to pain (positive: body movement or complaint of pain; Negative: No body movement or no reported pain. The dose will be adjusted, with a fluctuation step of 0.02 mg∙kg-1 up and down. All patients will receive a standardized anesthesia regimen, including the administration of midazolam at 0.03 mg∙kg-1 and hepatic portal nerve block (10 ml of 0.5% ropivacaine) under ultrasound guidance. Local anaesthesia will be administered using 10 ml of 1% lidocaine, which will be applied until the liver capsule is reached. The test will continue until six cross-pairings will be obtained. Probabilistic regression analysis will be used to calculate the ED50 and ED95 of esketamine with a 95% confidence interval.
(ii) The investigators will conduct a single-center, randomized, double-blind controlled trial in Phase Two to evaluate the safety of the esketamine ED95 dose under the monitoring anesthesia care program based on the incidence of respiratory depression. The intervention group will be injected with the dose of esketamine ED95; the control group will be first injected with fentanyl at a dose of 1 μg∙kg-1. Both groups of patients will receive the same anesthesia regimen, namely midazolam 0.03 mg∙kg-1, and hepatic portal nerve block (0.5% ropivacaine 10 ml) will be performed under ultrasound guidance. Intravenous injection of 100 mg of flurbiprofen axetil for auxiliary analgesia. Intravenous injection of 4 mg of ondansetron to prevent nausea and vomiting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This research will be divided into two stages. (i) In Phase one, a prospective dose discovery study using the Dixon sequential method will be conducted, aiming to determine the median effective dose (ED50) and 95% effective dose (ED95) of esketamine during ultrasound-guided hepatic tumor thermal ablation under hilar nerve block (HHNB). The sample size is approximately 27. (ii) The investigators will conduct a single-center, randomized, double-blind controlled trial in Phase Two to evaluate the safety of the esketamine ED95 dose under the monitoring anesthesia care program based on the incidence of respiratory depression. The intervention group will be injected with the dose of esketamine ED95; the control group will be injected with fentanyl 1 μg∙kg-1. Both groups of patients will receive the same sedation regimen. The sample size is approximately 52.
| Arm | Type | Receives |
|---|---|---|
| Determine the ED50 and ED95 of esketamine by Dixon's up-and-down method | Experimental | Drug: Intravenous esketamine using Dixon's up-and-down sequential methodUsing Dixon's up-and-down sequential method, esketamine will be titrated intravenously from an initial 0.3 mg∙kg-1 dose with 0.02 mg∙kg-1 adjustments based on intraprocedural responses to pain (positive: purposeful somatic movement or the complaint of pain; negative: no movement or no complaint of pain). All patients will receive standardized premedication with HHNB. The titration sequence will continue until six crossover inflection points are observed. |
| Evaluate the safety of the dose of esketamine ED95 by the incidence of respiratory depression | Active comparator | Drug: Intravenous the dose of esketamine ED95, Drug: Intravenous fentanyl 1 μg∙kg-1The intervention group will be injected with the dose of esketamine ED95; the control group will be injected with fentanyl 1 μg∙kg-1. The study at this stage will evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 - 80 years;
- ASA physical status Ⅰ or Ⅲ;
- Body mass index (BMI) 18 - 28 kg∙m-2;
- Scheduled for elective ultrasound-guided thermal ablation of solitary liver tumors under HHNB.
Key exclusion criteria (15 listed)
- Pharmacological contraindications:
- Known hypersensitivity to study medications (esketamine, midazolam);
- Opioid or benzodiazepine dependence;
- Using analgesics within the last 24 h preoperatively;
- Participation in other investigational drug trials within 90 days. (ii) Clinical comorbidities and surgery history:
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 |
|---|---|---|
| Intravenous esketamine using Dixon's up-and-down sequential methodAlso: Ultrasound-guided hepatic hilar nerve block (HHNB), Standardized premedication (midazolam 0.03 mg∙kg-1), Local anaesthesia using 10 ml of 1% lidocaineUsing Dixon's up-and-down sequential method, esketamine will be titrated intravenously from an initial 0.3 mg∙kg-1 dose with 0.02 mg∙kg-1 adjustments based on intraprocedural responses to pain (Positive: purposeful somatic movement or the complaint of pain; Negative: no movement or no complaint of pain). The titration sequence will continue until six crossover inflection points are observed. | Drug | Determine the ED50 and ED95 of esketamine by Dixon's up-and-down method |
| Intravenous the dose of esketamine ED95Also: Ultrasound-guided hepatic hilar nerve block (HHNB), Standardized premedication (midazolam 0.03 mg∙kg-1), Local anaesthesia using 10 ml of 1% lidocaineThe intervention group will be injected with the dose of esketamine ED95. | Drug | Evaluate the safety of the dose of esketamine ED95 by the incidence of respiratory depression |
| Intravenous fentanyl 1 μg∙kg-1Also: Ultrasound-guided hepatic hilar nerve block (HHNB), Standardized premedication (midazolam 0.03 mg∙kg-1), Local anaesthesia using 10 ml of 1% lidocaineThe control group will be injected with fentanyl 1 μg∙kg-1. | Drug | Evaluate the safety of the dose of esketamine ED95 by the incidence of respiratory depression |
Primary outcome
thermal ablation-induced somatic responses to pain
Time frame: Day 1 (During the surgery at the first stage of the research)
Positive: Body movement or complaint of pain. Negative: No body movement or no reported pain. This scale will be administered during the surgery at the first stage of the research.
Incidence of respiratory depression
Time frame: Day 1 (T2-T5 of the second stage of the research)
By comparing with the control group, evaluate the safety of ED95 of esketamine by the incidence of respiratory depression at T2-T5 of the second stage of the research. The primary outcome is the incidence of respiratory depression, which is defined as SpO2 <90% or EtCO2 >55 mmHg. T2: 60 seconds after esketamine injection; T3: 5 minutes after HHNB; T4: During thermal ablation of liver tumors; and T5: In the PACU.
14 secondary outcomes
HR
Time frame: Day 1 (T1-T5 of the first and second stages of the research)
MAP
Time frame: Day 1 (T1-T5 of the first and second stages of the research)
RR
Time frame: Day 1 (T1-T5 of the first and second stages of the research)
SPO2
Time frame: Day 1 (T1-T5 of the first and second stages of the research)
EtCO2
Time frame: Day 1 (T2-T5 of the first and second stages of the research)
Adverse events
Time frame: Day 1 (T2-T8 of the first and second stages of the research)
NRS
Time frame: Day 1 (T6-T8 of the first and second stages of the research)
The need for remedial analgesia
Time frame: Day 1 (T6-T8 of the first and second stages of the research)
Success rate of anesthesia
Time frame: Day 1 (T2-T4 of the second stage of the research)
Induction duration
Time frame: Day 1 of the second stage of the research
Duration of awakening
Time frame: Day 1 of the second stage of the research
Duration of stay in the hospital
Time frame: Day 1 and Day 2 of the second stage of the research
The satisfaction of the sonographer
Time frame: Day 1 of the second stage of the research
The satisfaction of patients
Time frame: Day 2 of the second stage of the research
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 11 Sep 2025.
- 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.
Lijuan Yan principal investigator
Department of Anesthesiology, The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravenous esketamine using Dixon's up-and-down sequential method, Intravenous the dose of esketamine ED95 and Intravenous fentanyl 1 μg∙kg-1 in people with Hepatic Neoplasm and Hepatic Cancer, run by The First Affiliated Hospital of Xiamen 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 4 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
thermal ablation-induced somatic responses to pain (time frame: Day 1 (During the surgery at the first stage of the research)). The study lists 2 primary outcomes in all. 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 11 Sep 2025.