Trial · NCT07034950
Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation
NCT07034950, Phase 1, Phase 2, Active not recruiting, The First Affiliated Hospital of Xiamen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation. Trials, record NCT07034950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07034950
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation
- NCT number
- NCT07034950
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 79 participants, estimated
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Conditions
- Hepatic Neoplasm, Hepatic Cancer
- Interventions
- Intravenous esketamine using Dixon's up-and-down sequential method, Intravenous the dose of esketamine ED95, Intravenous fentanyl 1 μg∙kg-1
- First posted
- 2025-06-24
- Last updated
- 2025-09-11
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | thermal ablation-induced somatic responses to pain | 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. |
| Primary | Incidence of respiratory depression | 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. |
| Secondary | HR | Day 1 (T1-T5 of the first and second stages of the research) | 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. |
| Secondary | MAP | Day 1 (T1-T5 of the first and second stages of the research) | 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. |
| Secondary | RR | Day 1 (T1-T5 of the first and second stages of the research) | 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. |
| Secondary | SPO2 | Day 1 (T1-T5 of the first and second stages of the research) | 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. |
| Secondary | EtCO2 | Day 1 (T2-T5 of the first and second stages of the research) | 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. |
| Secondary | Adverse events | Day 1 (T2-T8 of the first and second stages of the research) | 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. |
| Secondary | NRS | Day 1 (T6-T8 of the first and second stages of the research) | 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. |
| Secondary | The need for remedial analgesia | Day 1 (T6-T8 of the first and second stages of the research) | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07034950
GET https://conductscience.org/api/trials/v1/NCT07034950/registered