The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy
2026년 4월 23일 업데이트: Guolin Wang, Tianjin Medical University General Hospital
The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy:A Single-center Randomized Controlled Trial
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
160
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Guolin Wang
- 전화번호: +8615822855556
- 이메일: wangguolinghad@hotmail.com
연구 장소
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Tianjin, 중국, 300052
- Tianjin Medical University General Hospital
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연락하다:
- Guolin Wang
- 전화번호: +8618604755166
- 이메일: wangguolinghad@hotmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.
- Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.
- 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.
- Reporting pruritus NRS ≥ 4 points twice within one week.
- Planned to undergo cesarean section under intraspinal anesthesia.
- ASA classification: I - III grade.
Exclusion Criteria:
- Those who are known to be allergic to the drug components or have an allergic constitution.
- 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.
- Those with severe organic diseases and liver diseases.
- Those with malignant tumors.
- 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.
- Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies.
- ASA classification as grade IV.
- Those with poor compliance and unable to complete the trial according to the research protocol.
- Those who have participated in other drug clinical trials within the past 4 weeks.
Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion.
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공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Placebo group of parturients with ICP and pruritus received normal saline
The equal volume of normal saline was injected intravenously after fetal delivery during the operation
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The same volume of normal saline was injected after fetal delivery during the operation
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활성 비교기: Group of parturients with ICP and pruritus received esketamine 0.3mg/kg
Esketamine 0.3mg/kg was injected intravenously after fetal delivery during the operation
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Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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NRS pruritus score at 24 hours after surgery
기간: 24 hours after the surgery
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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.
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24 hours after the surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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5-D itch scale at 72 hours after surgery
기간: 72 hours after surgery
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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.
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72 hours after surgery
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NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery
기간: 6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
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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.
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6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
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The incidence of pruritus on the 24 hours after surgery
기간: 24 hours after surgery
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The NRS pruritus score was completed by the patient 24 hours after the operation.
The investigators recorded this score as a statistical indicator.
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24 hours after surgery
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Total bile acid at 24 hours after surgery
기간: 24 hours after surgery
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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.
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24 hours after surgery
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Pain Score (NRS)
기간: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
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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.
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6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
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The incidence of postoperative sleep disturbance on the first、second and third postoperative nights
기간: the first、second and third nights after surgery
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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.
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the first、second and third nights after surgery
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Postoperative anxiety
기간: 72 hours after the surgery
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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.
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72 hours after the surgery
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Postoperative depression
기간: 72 hours after the surgery
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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.
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72 hours after the surgery
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Key time points of the surgery
기간: Perioperative period
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Perioperative period
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Intraoperative average blood pressure（mmHg）
기간: Perioperative period
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Perioperative period
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Intraoperative average heart rate（times per minute）
기간: Perioperative period
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Perioperative period
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Intraoperative average blood oxygen saturation（%）
기간: Perioperative period
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Perioperative period
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Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)
기간: Perioperative period
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Perioperative period
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Adverse event
기간: Within 72 hours after the surgery
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All kinds of adverse events( nausea, vomiting, headache，etc) occurred in patients were recorded.
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Within 72 hours after the surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Guolin Wang, Tianjin Medical University General Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 5일
기본 완료 (추정된)
2027년 5월 5일
연구 완료 (추정된)
2027년 8월 11일
연구 등록 날짜
최초 제출
2026년 4월 10일
QC 기준을 충족하는 최초 제출
2026년 4월 23일
처음 게시됨 (실제)
2026년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 23일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB2026-YX-129-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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