Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT05299866
Status:
UNKNOWN
Last Update Posted:
2023-02-28
First Post:
2022-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-25', 'studyFirstSubmitDate': '2022-02-26', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The total number of presses of Patient-controlled Analgesia (PCA)', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'The total number of presses of PCA'}, {'measure': 'The percentage of using rescue analgesics', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'The percentage of using rescue analgesics'}, {'measure': 'The Richmond Agitation-Sedation Scale(RASS)', 'timeFrame': 'Hour 12 & Hour 24 & Hour 48 after surgery', 'description': 'Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)'}, {'measure': 'The incidence of postoperative adverse event', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc'}], 'primaryOutcomes': [{'measure': 'The percentage of patients with moderate-to-severe pain', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'Moderate-to-severe pain is defined as a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) pain score ≥4.'}], 'secondaryOutcomes': [{'measure': 'NRS pain score at rest and with movement', 'timeFrame': 'Hour 12 & Hour 24 & Hour 48 after surgery', 'description': 'Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['S-ketamine', 'Analgesia, Patient-Controlled', 'Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '30570761', 'type': 'BACKGROUND', 'citation': 'Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.'}, {'pmid': '29870457', 'type': 'BACKGROUND', 'citation': 'Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.'}, {'pmid': '27418219', 'type': 'BACKGROUND', 'citation': 'Isik Y, Dag ZO, Tulmac OB, Pek E. Early postpartum lactation effects of cesarean and vaginal birth. Ginekol Pol. 2016;87(6):426-30. doi: 10.5603/GP.2016.0020.'}, {'pmid': '27118118', 'type': 'BACKGROUND', 'citation': 'Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial is designed to investigate the effect of low-dose of S-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status II\n* Patients aged between 20 and 40 years\n* 18 kg/m² ≤BMI≤30 kg/m²\n* singleton term pregnancy\n* scheduled for elective cesarean section\n\nExclusion Criteria:\n\n* Refused to participant in this trial\n* Severe heart dysfunction or pulmonary insufficiency\n* Poor blood pressure control in those with hypertension (BP \\>160/100 mmHg in the ward)\n* Previous history of Intracranial hypertension or hyperthyroidism\n* Previous history of schizophrenia, epilepsy, myasthenia gravis or delirium\n* Allergy to drugs used in the study'}, 'identificationModule': {'nctId': 'NCT05299866', 'briefTitle': 'The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'The Effect of Low-dose of S-ketamine Combined With Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Patients Following Cesarean Section', 'orgStudyIdInfo': {'id': 'YXLL-KY-2021(071)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-ketamine group', 'description': 'The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.', 'interventionNames': ['Drug: S-ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'S-ketamine', 'type': 'DRUG', 'description': 'After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.', 'armGroupLabels': ['S-ketamine group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'After surgery, patient-controlled analgesia is provided. The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Dong, Ph.D', 'role': 'CONTACT', 'email': 'dongling1668@163.com', 'phone': '18866862815'}], 'facility': 'Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Ling Dong, Ph.D', 'role': 'CONTACT', 'email': 'dongling1668@163.com', 'phone': '18866862815'}, {'name': 'Ling Dong, MD', 'role': 'CONTACT', 'email': 'dongling1668@163.com', 'phone': '18866862815'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ling Dong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Ling Dong', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}