Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT07235995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paracetamol and Mannitol Injection and Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1092}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'postoperative days 1-5', 'description': 'Subjective quality of sleep assessed using NRS (an 11-point scale where 0 = the best sleep and 10 = the worst sleep) once daily (8:00-10:00 am) during postoperative days 1-5'}, {'measure': 'Biomarker of delirium', 'timeFrame': 'Postoperative day 1', 'description': 'Biomarker of delirium including S100b and NSE on postoperative day 1'}, {'measure': 'Neuro monitoring of delirium', 'timeFrame': 'Postoperative days 1-5', 'description': 'Monitoring of neurophysiological function, with detecting SctO2 during postoperative days 1-5'}], 'primaryOutcomes': [{'measure': 'Rate of delirium', 'timeFrame': 'postoperative 1- 5 days', 'description': 'Delirium assessed using CAM-ICU every 12 hours (8am, 8 pm) during postoperative days 1-5 and RASS transform at any time'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30-day after surgery', 'description': '30-days outcome (survival or death) after surgery; Patients will be assessed via phone call if they are discharged before day 30 after surgery'}, {'measure': 'Severity of pain', 'timeFrame': 'postoperative days 1-5', 'description': 'Severity of pain assessed using numeric rating scale (NRS), 8am and 8pm, twice a day, for 5 day The scale consists of 11 points from 0 to 10, where 0 indicates "no pain" and 10 indicates "severe pain". Patients select the corresponding number based on their pain level. \\<4 points indicate mild pain (no impact on sleep), 4-6 points indicate moderate pain, and ≥7 points indicate severe pain (pain prevents sleep or causes waking).'}, {'measure': 'Length of ICU stay', 'timeFrame': 'immediately after surgery', 'description': 'Length of ICU stay after surgery admitted to ICU'}, {'measure': 'Length of hospital stay', 'timeFrame': 'immediately after surgery', 'description': 'Length of hospital stay within hospital admission'}, {'measure': 'Quality of life of 30-day survivors', 'timeFrame': 'day 30 after surgery', 'description': 'Patients will be assessed with World Health Organization Quality of Life Assessment Instrument Short Form (WHOQOL-BREF) via phone call if they are discharged before day 30 after surgery The scale contains 26 items covering four domains: physiological, psychological, social relations, and environmental. It uses a 1-5-point Likert scale for scoring, and the original scores are converted into a standard score of 0-100. The higher the score, the better the quality of life.'}, {'measure': 'Cognitive function of 30-day survivors', 'timeFrame': 'day 30 after surgery', 'description': 'Patients will be assessed with TICS-m via phone call if they are discharged before day 30 after surgery'}, {'measure': 'Incidence of non-delirium-related complications', 'timeFrame': '30 days after surgery', 'description': 'Complications unrelated to delirium occurring within 30 days postoperatively (e.g., cardiovascular events, cerebrovascular events, renal impairment, GI complications, infections, etc.) are defined as any newly developed complications that may affect patient recovery and require therapeutic intervention (including hospital admission).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative delirium', 'Intravenous acetaminophen', 'Elderly', 'Noncardiac surgical patients'], 'conditions': ['Postoperative Delirium', 'Elderly', 'Non Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this multi-center RCT is to investigate the effect of intravenous acetaminophen (paracetamol and mannitol injection) on postoperative delirium, comparing with intravenous sufentanil, in elderly noncardiac surgical patients admitted to ICU.', 'detailedDescription': 'Delirium is a common complication after surgery. It is associated with increased morbidity and mortality, longer intensive care unit (ICU) and hospital stay, prolonged mechanical ventilation, higher risk of institutionalization, and higher healthcare cost. Depending on patient population and screening method, the incidence of delirium in elderly patients admitted to ICU can be as high as 58-76%. The choice of analgesics and the adequacy of pain control are among the modifiable precipitating factors for postoperative delirium (POD). Whether the use of intravenous acetaminophen decreases the occurrence of POD in elderly noncardiac surgical patients admitted to ICU remains inadequately studied.\n\nObjectives: To investigate the effect of intravenous acetaminophen (paracetamol and mannitol injection) on postoperative delirium, comparing with intravenous sufentanil, in elderly noncardiac surgical patients admitted to ICU.\n\nStudy design: A randomized controlled trial. Setting: 34 ICUs from different regions across China. Patients: 1092 elderly patients (≥ 60 years), having noncardiac surgery and admitted to ICU after surgery, are eligible.\n\nIntervention: Patients are randomly assigned to intravenous acetaminophen or sufentanil groups. Intravenous acetaminophen is the analgesic of choice for patients in the acetaminophen group. Intravenous sufentanil is the analgesic of choice for patients in the sufentanil group (control).\n\nOutcomes: The primary endpoint is the incidence of delirium within the first 5 days after surgery. Delirium is assessed using the confusion assessment method for the intensive care unit (CAM-ICU). The secondary endpoints include the level of pain assessed using the Numeric Rating Scale (NRS) on postoperative day 1 to 5 and day 30, 30-day mortality, length of ICU and hospital stay, quality of life assessed on postoperative day 30, cognitive function assessed on postoperative day 30, and biomarkers and neurofunctional testing for delirium.\n\nPredicted duration of the study: 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 60 years;\n* Admitted to ICU after a noncardiac surgical procedure\n* Moderate to severe acute pain, with a postoperative pain score ≥ 5 based on the 11-point Numerical Pain Rating Scale (NPRS)\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Preoperative medical history: schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis\n* History of psychiatric disease or significant neurocognitive disorder such as dementia or retardation, making POD assessment impossible\n* Language or communication barrier making POD assessment impossible\n* Intracranial surgery\n* Severe hepatic dysfunction prohibiting the use of acetaminophen per the standard of care\n* Participation in a competing study within 30d\n* Patients experienced intraoperative or postoperative complications, and the investigator determined the subject was unsuitable to continue participation in the study\n* Intolerant to paracetamol or opioid drugs"}, 'identificationModule': {'nctId': 'NCT07235995', 'acronym': 'PAPOD-ES', 'briefTitle': 'Paracetamol and Mannitol Injection and Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Impact of Paracetamol and Mannitol Injection Analgesia on Postoperative Delirium in Elderly Patients After Non-cardical Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202510115'}, 'secondaryIdInfos': [{'id': '202510115', 'type': 'OTHER', 'domain': 'Xiangya Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetaminophen group', 'description': 'Intravenous acetaminophen is the analgesic of choice for patients in the acetaminophen group', 'interventionNames': ['Drug: Acetaminophen group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sufentanil group', 'description': 'Intravenous sufentanil is the analgesic of choice for patients in the sufentanil group', 'interventionNames': ['Drug: Sufentanil group']}], 'interventions': [{'name': 'Acetaminophen group', 'type': 'DRUG', 'description': 'The pain in this group is controlled using acetaminophen (Paracetamol and Maninitol Injection, Yichang Renfu Medicine Co., Ltd., China), 500 mg, intravenous bolus, every 6 hours for the first 48 hours postoperatively. The severity of pain is assessed using NRS every 15 minutes during the first hour following ICU admission and then once every 12 hours needed.', 'armGroupLabels': ['Acetaminophen group']}, {'name': 'Sufentanil group', 'type': 'DRUG', 'description': 'he pain in this group is controlled using sufentanil (Yichang Renfu Medicine Co., Ltd., China) intravenous infusion with a rate of 0.05 μg/kg/h. The severity of pain is assessed using NRS every 15 minutes during the first hour following ICU admission and then once every 12 hours needed.', 'armGroupLabels': ['Sufentanil group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Milin Peng, Dr.', 'role': 'CONTACT', 'email': 'pengmilin@csu.edu.cn', 'phone': '86+15211040348'}], 'facility': 'Xiangya hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Lina Zhang, Dr.', 'role': 'CONTACT', 'email': 'zln7095@163.com', 'phone': '86+15874875763'}, {'name': 'Milin Peng, Dr.', 'role': 'CONTACT', 'email': 'pengmilin@csu.edu.cn', 'phone': '86+15211040348'}], 'overallOfficials': [{'name': 'Yixiong Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'icuzhanglina', 'investigatorAffiliation': 'Xiangya Hospital of Central South University'}}}}