The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery
The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery: A Single-center Randomized Controlled Study
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Guolin Wang, Study Director
- Puhelinnumero: +8615822855556
- Sähköposti: wangguolinghad@hotmail.com
Opiskelupaikat
-
-
-
Tianjin, Kiina
- Tianjin Medical University General Hospital, Tianjin, 300052
-
Ottaa yhteyttä:
- Guolin Wang, Study Director
- Puhelinnumero: +8615822855556
- Sähköposti: wangguolinghad@hotmail.com
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
1. Inclusion Criteria:
- Patients with cholestasis caused by bile duct stones, gallbladder stones, bile duct strictures, pancreatic head cancer, cholangiocarcinoma, or periampullary carcinoma, etc.
- Manifestations of cholestatic pruritus, typically with the palms and soles as the initial or most severely affected sites, which may extend to the limbs and trunk; possibly accompanied by jaundice (yellowing of the skin and sclera), dark urine (e.g., tea-colored), and clay-colored stools; often with a tendency to worsen at night.
- Report of pruritus with an NRS score ≥ 4 (moderate to severe pruritus) twice within one week.
- Scheduled for elective hepatobiliary surgery under general anesthesia, including but not limited to: partial hepatectomy, common bile duct exploration, choledocholithotomy, biliary-enteric anastomosis (e.g., Roux-en-Y anastomosis), pancreaticoduodenectomy (Whipple procedure), and radical resection of hilar cholangiocarcinoma.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Age ≥ 18 years, body mass index (BMI) between 18 and 30 kg/m², regardless of gender.
- Patients have fully understood the nature of the study, voluntarily agree to participate, and have signed the informed consent form.
Exclusion Criteria:
- Known allergy to any component of the study drug or history of allergic constitution;
- History of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
- History of neurological disease; history of chronic pain; substance abuse or alcoholism; long-term use of opioids; administration of opioids within 48 hours prior to surgery;
- ASA physical status classification IV;
- Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, renal dysfunction, or marked electrolyte abnormalities;
- History of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
- Respiratory insufficiency or respiratory failure;
- Preoperative diagnosis of severe liver failure of Child-Pugh class C or presence of hepatic encephalopathy;
- Other pruritic disorders: uremic pruritus, polycythemia vera, cutaneous T-cell lymphoma, hypereosinophilia, drug eruption and drug-induced pruritus, as well as other pruritic diseases that may be easily confused, such as atopic dermatitis, pemphigoid, scabies, delusional parasitosis, dermatitis artefacta, etc.;
- Pregnant or breastfeeding women;
- BMI < 18 kg/m² or BMI > 30 kg/m²;
- Poor compliance or inability to complete the study according to the protocol;
- Participation in another drug clinical trial within the past 4 weeks;
- Any other condition that, in the opinion of the investigators, makes the patient unsuitable for enrollment.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Active Comparator: Patients receiving esketamine intervention
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation.
|
Continuous intraoperative infusion of esketamine at 0.3 mg/kg/h
|
|
Placebo Comparator: Patients receiving an equal volume of saline
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.
|
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
NRS scores for pruritus assessed in the morning and evening on postoperative day 1
Aikaikkuna: The morning and evening of the first day after the operation
|
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition.
The higher the number, the more severe the itching.
0: No sensation.
1-3: Mild itching.
4-6: Moderate itching.
7-9: Severe itching.
10: Extremely severe itching.
|
The morning and evening of the first day after the operation
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
The NRS scores for pruritus in the morning and evening on the second and third days after the operation.
Aikaikkuna: On the morning and evening of the second and third days after the operation
|
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition.
The higher the number, the more severe the itching.
0: No sensation.
1-3: Mild itching.
4-6: Moderate itching.
7-9: Severe itching.
10:Extremely severe itching.
|
On the morning and evening of the second and third days after the operation
|
|
The incidence of sleep disorders on postoperative days 1-3
Aikaikkuna: The first, second and third days after the surgery
|
Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first, second and third day after surgery.
The AIS has a total of 8 items, with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.
The investigators asked the patients to fill out this questionnaire after the first, second and third postoperative nights to evaluate the changes in sleep quality.
The investigators recorded AIS scores as statistical indicators.
|
The first, second and third days after the surgery
|
|
Postoperative anxiety
Aikaikkuna: 1 day before surgery ,1 -3 days after surgery
|
Patients completed the anxiety rating scales (HADS-A, Hospital Anxiety and Depression Scale-Anxiety subscale) on the day before surgery.
HADS-A consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety.
And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in anxiety.
The investigators recorded HADS-A scores as statistical indicators
|
1 day before surgery ,1 -3 days after surgery
|
|
Postoperative depression
Aikaikkuna: 1 day before surgery ,1 -3 days after surgery
|
Patients completed the depression rating scales (HADS-D, Hospital Anxiety and Depression Scale-Depression subscale) on the day before surgery.
HADS-D consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression.
And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in depression.
The investigators recorded HADS-D scores as statistical indicators.
|
1 day before surgery ,1 -3 days after surgery
|
|
Pain Score (NRS)
Aikaikkuna: 1-3 days after surgery
|
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
|
1-3 days after surgery
|
|
5-D itch scale at 72 hours after surgery
Aikaikkuna: 72 hours after surgery
|
The duration, severity, outcome trend, life impairment, and pruritus site (5-D) were used to evaluate the patient's pruritus.
Each dimension was scored from 1 to 5, with a total score ranging from 5 to 25.
The higher the score, the more severe the itching
|
72 hours after surgery
|
|
Liver function tests (LFTs)
Aikaikkuna: Preoperative baseline and postoperative day one
|
|
Preoperative baseline and postoperative day one
|
|
Postoperative Complications
Aikaikkuna: Within 72 hours postoperatively
|
|
Within 72 hours postoperatively
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- IRB2025-YX-497-01
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .