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Trial · NCT07034950

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primarythermal ablation-induced somatic responses to painDay 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.
PrimaryIncidence of respiratory depressionDay 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.
SecondaryHRDay 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.
SecondaryMAPDay 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.
SecondaryRRDay 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.
SecondarySPO2Day 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.
SecondaryEtCO2Day 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.
SecondaryAdverse eventsDay 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.
SecondaryNRSDay 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.
SecondaryThe need for remedial analgesiaDay 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.
SecondarySuccess rate of anesthesiaDay 1 (T2-T4 of the second stage of the research)
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
SecondaryInduction durationDay 1 of the second stage of the researchInduction 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.
SecondaryDuration of awakeningDay 1 of the second stage of the researchDuration of awakening is defined as the period from the conclusion of the surgical procedure to the moment of eye-opening.
SecondaryDuration of stay in the hospitalDay 1 and Day 2 of the second stage of the researchDuration of stay in the hospital is measured from the moment the patient enters the operating room until the moment they are discharged.
SecondaryThe satisfaction of the sonographerDay 1 of the second stage of the researchThe 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.
SecondaryThe satisfaction of patientsDay 2 of the second stage of the researchThe 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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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