Intrahepatic Cholestasis of Pregnancy
Conditions
Keywords
esketamine, pruritus
Brief summary
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
Detailed description
Intrahepatic cholestasis of pregnancy (ICP) is an important obstetric complication that occurs in the middle and late stages of pregnancy, characterized mainly by pruritus and elevated serum total bile acid (TBA) levels. Pruritus usually begins on the palms and soles of the feet and can gradually spread. It typically shows a 'lighter during the day and heavier at night' pattern, severely affecting the patient's quality of life. It can also lead to physical and psychological disorders, and even cause mental abnormalities and self-harming behaviors in patients. Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief, rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an important role in the transmission of non-histaminergic itching. Eslicarbazepine acetate, as a highly selective NMDA receptor antagonist, may alleviate the transmission and propagation of itching. However, there are no reports on whether a single intravenous injection of esketamine can alleviate the pruritus symptoms of patients with pregnancy-induced intrahepatic cholestasis. This experiment aims to investigate the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with pregnancy-induced intrahepatic cholestasis.
Interventions
DRUGNormal Saline (0.9% NaCl)
The same volume of normal saline was injected after fetal delivery during the operation
Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation
Sponsors
Tianjin Medical University General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy. 2. Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up. 3. Meet the diagnostic criteria of the "Clinical Diagnosis, Treatment and Management Guidelines for Intrahepatic Cholestasis of Pregnancy (2024 Edition)" : fasting serum TBA≥10 μmol/L or postprandial serum TBA≥19 μmol/L. 4. Reporting pruritus NRS ≥ 4 points twice within one week. 5. Planned to undergo cesarean section under intraspinal anesthesia. 6. ASA classification: I - III grade.
Exclusion criteria
1. Those who are known to be allergic to the drug components or have an allergic constitution. 2. Related to the safe use of esketamine: history of mental illness; uncontrolled hypertension; uncontrolled hyperthyroidism; increased intracranial pressure, increased intraocular pressure; long-term alcohol consumption or drug abuse history. 3. Those with severe organic diseases and liver diseases. 4. Those with malignant tumors. 5. Other pruritic diseases: uremic pruritus, true erythrocytosis, cutaneous T-cell lymphoma, eosinophilia, drug rash and drug-induced pruritus, and other pruritic diseases that are easily confused, such as atopic dermatitis, pemphigus, scabies, parasitic delusionism, artificial dermatitis, etc. 6. Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies. 7. ASA classification as grade IV. 8. Those with poor compliance and unable to complete the trial according to the research protocol. 9. Those who have participated in other drug clinical trials within the past 4 weeks. 10. Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS pruritus score at 24 hours after surgery | 24 hours after the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-D itch scale at 72 hours after surgery | 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. |
| NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery | 6 hours、12 hours、48 hours、72 hours and the seventh day after surgery | 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 incidence of pruritus on the 24 hours after surgery | 24 hours after surgery | The NRS pruritus score was completed by the patient 24 hours after the operation. The investigators recorded this score as a statistical indicator. |
| Total bile acid at 24 hours after surgery | 24 hours after surgery | The patient's fasting total bile acid level was checked the day before the operation. The investigators rechecked the fasting total bile acid levels 24 hours after the patient's surgery to assess the changes in total bile acid. |
| Pain Score (NRS) | 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the 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. |
| The incidence of postoperative sleep disturbance on the first、second and third postoperative nights | the first、second and third nights after surgery | The patient completed the Sleep Quality Scale (AIS，Athens Insomnia Scale) one day before the surgery. There are a total of 8 items in the AIS, with the score ranging from 0 to 24. A total score of 6 or above indicates a diagnosis of insomnia. We 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. |
| Postoperative anxiety | 72 hours after the surgery | The patient completed the Self-Rating Anxiety Scale (SAS, Self-Rating Anxiety Scale) one day before the surgery. The SAS consists of 20 items. Among them, 15 items are positive ratings (such as "I feel more nervous and anxious than usual"), and 5 items are negative ratings (such as "I feel everything is fine", which are the reverse items numbered 5, 9, 13, 17, and 19). The content covers subjective feelings of anxiety and various physical symptoms. The investigators asked the patient to fill out this questionnaire again 72 hours after the surgery to assess the changes in anxiety. |
| Postoperative depression | 72 hours after the surgery | The patient completed the Edinburgh Depression Scale (EPDS) one day before the surgery. The EPDS consists of 10 items, covering aspects such as mood, anxiety, and self-blame. Scores range from 0 to 9: within the normal range, no special intervention is required; 10-12: borderline range, suggesting a need for follow-up observation; 13-30: screening positive, indicating possible postpartum depression, and further assessment is necessary. The investigators asked the patient to fill out this questionnaire again at the seventy-second hour after the surgery to assess the changes in depression. |
| Key time points of the surgery | Perioperative period | 1. Duration of anesthesia （minutes） 2. Duration of surgery （minutes） 3. The time of fetal delivery（minutes） |
| Intraoperative average blood pressure（mmHg） | Perioperative period | — |
| Intraoperative average heart rate（times per minute） | Perioperative period | — |
| Intraoperative average blood oxygen saturation（%） | Perioperative period | — |
| Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.) | Perioperative period | — |
| Adverse event | Within 72 hours after the surgery | All kinds of adverse events( nausea, vomiting, headache，etc) occurred in patients were recorded. |
Countries
China
Contacts
CONTACTGuolin Wang
STUDY_DIRECTORGuolin Wang
Tianjin Medical University General Hospital
Outcome results
None listed