A Phase 4 interventional study of Esketamine and Sufentanil in Hepatocellular Carcinoma, Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Phase 4, Interventional, and Treatment
Previous studies have confirmed that limb pain caused by oxaliplatin chemotherapy is related to spinal cord central sensitization - induced hyperalgesia through oxaliplatin activating spinal cord NMDA receptor(N-methyl-D-aspartic acid receptor). The investigators speculate that this may be the same as the mechanism of severe abdominal pain caused by HAIC(Hepatic Artery Infusion Chemotherapy) during oxaliplatin infusion. The analgesic effect of Esketamine is mainly related to its inhibition of NMDA receptor in spinal cord. Therefore, this study hypothesized that Esketamine can inhibit the sensitization of spinal cord center by inhibiting NMDA receptor, so as to alleviate severe abdominal pain during HAIC perfusion, and reduce abdominal pain caused by ischemia and inflammation by TACE(transcatheter arterial chemoembolization) by improving organ perfusion and anti-inflammatory effect, Therefore, it is expected that Esketamine can better alleviate acute severe abdominal pain caused by TACE-HAIC (transcatheter arterial chemoembolization combined with Hepatic Artery Infusion Chemotherapy )treatment than sufentanil, decrease the dosage of opioids, and reduce the incidence and degree of chronic abdominal pain after treatment.
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PCIA formula：100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline.
Drug: Esketamine
PCIA formula：100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline.
Drug: Sufentanil
PCIA formula：100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline. 30min before TACE treatment, the first dose of 2ml was slowly injected intravenously. No obvious adverse reactions were observed for 10min. After that, the intravenous analgesia pump was started. Parameter setting of intravenous analgesia pump: the total volume is 100ml; The duration is 2ml / h; The single dose is 2ml each time; The limit quantity is 10ml / h; The locking time was 10min and the analgesia lasted for 48h. The target value of analgesia in this study was NRS (Numerical Rating Scale)\< 4; If NRS ≥ 4, when the effect is still poor after adding drugs by pressing the analgesic pump, the investigators will give the remedial drug(dolantin 50mg im st) according to the patient's condition.
Also known as: patient controlled intravenous analgesia
PCIA formula：100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline. 30min before TACE treatment, the first dose of 2ml was slowly injected intravenously. No obvious adverse reactions were observed for 10min. After that, the intravenous analgesia pump was started. Parameter setting of intravenous analgesia pump: the total volume is 100ml; The duration is 2ml / h; The single dose is 2ml each time; The limit quantity is 10ml / h; The locking time was 10min and the analgesia lasted for 48h. The target value of analgesia in this study was NRS (Numerical Rating Scale)\< 4; If NRS ≥ 4, when the effect is still poor after adding drugs by pressing the analgesic pump, the investigators will give the remedial drug(dolantin 50mg im st) according to the patient's condition.
Also known as: patient controlled intravenous analgesia
Maximum pain intensity in the first 3 hours of HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From the beginning of HAIC treatment to 3 hours after HAIC treatment
Pain intensity at 1 hour after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From the beginning of HAIC treatment to 1 hour after HAIC treatment
Pain intensity at 2 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 1 hour to 2 hours after HAIC treatment
Pain intensity at 3 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 2 hours to 3 hours after HAIC treatment
Numbers of analgesic pump compressions
When the patients felt pain, the patient controlled analgesia pump can be pressed once
Time frame: From the beginning of HAIC treatment to 48 hours after HAIC treatment
Analgesic consumption
Analgesic consumption is assessed by the total amount of pain remedy with dolantin when the analgesic effect is poor after pressing analgesic pump for 3 times or more
Time frame: From the beginning of HAIC treatment to 48 hours after HAIC treatment
Pain intensity at 8 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 7 hours to 8 hours after HAIC treatment
Pain intensity at 16 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 15 hours to 16 hours after HAIC treatment
Pain intensity at 24 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 23 hours to 24 hours after HAIC treatment
Pain intensity at 32 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 31 hours to 32 hours after HAIC treatment
Pain intensity at 40 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 39 hours to 40 hours after HAIC treatment
Pain intensity at 48 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 47 hours to 48 hours after HAIC treatment
Pain intensity on the seventh days after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 7 days to 8 days after HAIC treatment
Pain intensity On the 14th day after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 13 days to 14 days after HAIC treatment
Pain intensity on the 21st after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Time frame: From 20 days to 21 days after HAIC treatment
Ramsay Sedation score at 1 hour after HAIC treatment
Ramsay Sedation score is assessed by: Grade 1 (soberness- the patient is anxious, uneasy or irritable)、 Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)、 Grade 3 (soberness- the patient only responds to commands)、 Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)、 Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.
Time frame: From the beginning of HAIC treatment to 1 hour after HAIC treatment
Ramsay Sedation score at 2 hours after HAIC treatment
Ramsay Sedation score is assessed by: Grade 1 (soberness- the patient is anxious, uneasy or irritable)、 Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)、 Grade 3 (soberness- the patient only responds to commands)、 Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)、 Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.
Time frame: From 1 hour to 2 hours after HAIC treatment
Ramsay Sedation score at 3 hours after HAIC treatment
Ramsay Sedation score is assessed by: Grade 1 (soberness- the patient is anxious, uneasy or irritable)、 Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)、 Grade 3 (soberness- the patient only responds to commands)、 Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)、 Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.
Time frame: From 2 hours to 3 hours after HAIC treatment
Ramsay Sedation score at 8 hours after HAIC treatment
Ramsay Sedation score is assessed by: Grade 1 (soberness- the patient is anxious, uneasy or irritable)、 Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)、 Grade 3 (soberness- the patient only responds to commands)、 Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)、 Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.
Time frame: From 7 hours to 8 hours after HAIC treatment
The quality of sleep on the fist day after HAIC treatment
The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0\~25 points indicate poor sleep quality;76\~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)
Time frame: From the ending of HAIC treatment to 1 day after HAIC treatment
The quality of sleep on the second day after HAIC treatment
The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0\~25 points indicate poor sleep quality;76\~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)
Time frame: From 1 day to 2 days after HAIC treatment
The quality of sleep on the third day after HAIC treatment
The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0\~25 points indicate poor sleep quality;76\~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)
Time frame: From 2 days to 3 days after HAIC treatment
Adverse reaction
Adverse reaction is recorded according to follow-up visits after HAIC treatment
Time frame: From the beginning of HAIC treatment to 72 hours after HAIC treatment
Degree of satisfaction
Degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction;higher scores mean a better outcome)
Time frame: From the beginning of HAIC treatment to 24 hours after HAIC treatment
Plan to share: Yes — The individual participant data for this study is available from the sponsor on reasonable request through email.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
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The Second Affiliated Hospital of Chongqing Medical University