An interventional study of Normal Saline (0.9% NaCl) and Esketamine 0.3mg/kg in Intrahepatic Cholestasis of Pregnancy, sponsored by Tianjin Medical University General Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Tianjin Medical University General Hospital · Not applicable, Interventional, and Treatment
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
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.
26 studies on the registry are indexed under Intrahepatic Cholestasis of Pregnancy; 10 are open to participants now.
Browse Intrahepatic Cholestasis of Pregnancy studies →Tianjin Medical University General Hospital is the lead sponsor of 75 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The equal volume of normal saline was injected intravenously after fetal delivery during the operation
Drug: Normal Saline (0.9% NaCl)
Esketamine 0.3mg/kg was injected intravenously after fetal delivery during the operation
Drug: Esketamine 0.3mg/kg
The same volume of normal saline was injected after fetal delivery during the operation
Drug page: Esketamine
Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation
NRS pruritus score at 24 hours 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.
Time frame: 24 hours after the surgery
5-D itch scale at 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.
Time frame: 72 hours after surgery
NRS pruritus score at 6 hours、12 hours、48 hours、72h ours 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.
Time frame: 6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
The incidence of pruritus on the 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.
Time frame: 24 hours after surgery
Total bile acid at 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.
Time frame: 24 hours after surgery
Pain Score (NRS)
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.
Time frame: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
The incidence of postoperative sleep disturbance on the first、second and third postoperative nights
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.
Time frame: the first、second and third nights after surgery
Postoperative anxiety
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.
Time frame: 72 hours after the surgery
Postoperative depression
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.
Time frame: 72 hours after the surgery
Key time points of the surgery
1. Duration of anesthesia （minutes） 2. Duration of surgery （minutes） 3. The time of fetal delivery（minutes）
Time frame: Perioperative period
Intraoperative average blood pressure（mmHg）
Time frame: Perioperative period
Intraoperative average heart rate（times per minute）
Time frame: Perioperative period
Intraoperative average blood oxygen saturation（%）
Time frame: Perioperative period
Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)
Time frame: Perioperative period
Adverse event
All kinds of adverse events( nausea, vomiting, headache，etc) occurred in patients were recorded.
Time frame: Within 72 hours after the surgery
Plan to share: No
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Studies of the drug tested here: Esketamine
Intrahepatic Cholestasis of Pregnancy →
Tianjin Medical University General Hospital