Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-02 @ 1:32 PM
Study NCT ID:
NCT07204795
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Oral Carbohydrate Drink on ObsQoR-10 Score After Elective Cesarean Under Neuraxial Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-05-17', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ObsQor-10 Scores', 'timeFrame': 'From enrollment to 48th hour postoperatively', 'description': 'Primary outcome assessment will be based on the ObsQoR-10 (Obstetric Quality of Recovery-10) scores at 24 and 48 hours postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ObsQor-10', 'Cesarean Section', 'Neuraxial Anesthesia', 'Preoperative Fasting', 'Oral Clear Carbohydrate Drink'], 'conditions': ['ObsQor-10', 'Cesarean Section', 'Preoperative Fasting']}, 'referencesModule': {'references': [{'pmid': '36301286', 'type': 'BACKGROUND', 'citation': 'Kozanhan B, Yildiz M, Polat A, Gunenc O, Tutar SM, Iyisoy MS, Kulhan NG, Sultan P. Development and Validation of a Turkish Version of Obstetric Quality of Recovery-10. Turk J Anaesthesiol Reanim. 2022 Oct;50(5):366-372. doi: 10.5152/TJAR.2022.21441.'}, {'pmid': '33591115', 'type': 'BACKGROUND', 'citation': 'Cho EA, Huh J, Lee SH, Ryu KH, Shim JG, Cha YB, Kim MS, Song T. Gastric Ultrasound Assessing Gastric Emptying of Preoperative Carbohydrate Drinks: A Randomized Controlled Noninferiority Study. Anesth Analg. 2021 Sep 1;133(3):690-697. doi: 10.1213/ANE.0000000000005411.'}, {'pmid': '30579408', 'type': 'BACKGROUND', 'citation': 'Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to determine whether a preoperative oral carbohydrate-rich clear drink can improve recovery in women undergoing elective cesarean section under neuraxial anesthesia. The main outcomes it aims to answer are:\n\nPrimary Outcome: Does the carbohydrate drink improve ObsQoR-10 scores at 24 and 48 hours postoperatively?\n\nSecondary Outcomes: Does it reduce patients' hunger, thirst, and anxiety levels?\n\nResearchers will compare patients receiving a 400 ml oral carbohydrate-rich clear drink 2 hours before surgery (Group A) to those receiving 400 ml distilled water (Group B), to assess differences in recovery and comfort.\n\nParticipants will:\n\nBe randomized into two equal groups (n=50 each) using a computer-generated randomization table\n\nReceive standardized anesthesia and postoperative analgesia", 'detailedDescription': 'This prospective, randomized, controlled, double-blind clinical trial will be conducted at Atatürk University Faculty of Medicine Hospital, following approval from the institutional ethics committee and after obtaining written informed consent from all participants. The study population will consist of 100 pregnant women scheduled for elective cesarean section under neuraxial anesthesia.Randomization will be performed using a computer-generated random numbers table by an independent statistician, allocating patients equally into two groups (Group A and Group B). Randomization will be performed using a computer-generated random numbers table by an independent statistician, allocating patients equally into two groups (Group A and Group B).\n\nUpon arrival in the operating room, patients will undergo routine monitoring. Cesarean delivery will be performed using either spinal anesthesia or combined spinal-epidural anesthesia based on clinical indications. Intrathecal anesthesia will consist of 11.2 mg hyperbaric bupivacaine, 15 µg fentanyl, and 150 µg morphine. If additional analgesia is required through the epidural route, a mixture of 15 mL 2% lidocaine, 2 mL fentanyl, 2 mL sodium bicarbonate, and 1:200,000 adrenaline will be administered.\n\nFor intraoperative analgesia, all patients will receive 1 g intravenous acetaminophen, and, if not contraindicated, 800 mg intravenous ibuprofen. Postoperative pain management will include scheduled doses of 1 g acetaminophen and 800 mg ibuprofen every 8 hours for 48 hours. If the visual analog pain score (VAS) exceeds 3, 5 mg of oral oxycodone will be given as rescue analgesia. At discharge, patients will be prescribed up to 20 tablets of 5 mg oxycodone for breakthrough pain, with advice to continue regular acetaminophen and ibuprofen.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge ≥18 years\n\nScheduled for elective cesarean section under neuraxial anesthesia\n\nGestational age ≥37 weeks\n\nExclusion Criteria:\n\nContraindication to neuraxial anesthesia\n\nAge \\<18 years\n\nRefusal to participate in the study\n\nObesity\n\nHiatal hernia\n\nIntestinal obstruction\n\nGastroesophageal reflux disease (GERD)\n\nDiabetes mellitus\n\nFetal anomalies\n\nEclampsia or preeclampsia\n\nSubstance abuse\n\nChronic pain conditions'}, 'identificationModule': {'nctId': 'NCT07204795', 'briefTitle': 'Effect of Preoperative Oral Carbohydrate Drink on ObsQoR-10 Score After Elective Cesarean Under Neuraxial Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Evaluation of the Effect of Preoperatively Administered Oral Clear Carbohydrate-Rich Drink on ObsQoR-10 Recovery Scores of Patients Undergoing Elective Cesarean Section With Neuraxial Anesthesia: A Prospective, Randomized, Controlled, Double-Blind Study', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00/331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Control Group will receive distilled water.', 'interventionNames': ['Other: Distilled water group']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'This arm of patients will receive clear carbohydrate drink.', 'interventionNames': ['Other: Carbohydrate Drink']}], 'interventions': [{'name': 'Distilled water group', 'type': 'OTHER', 'description': 'Group A participants will receive 400 mL of distilled water orally, two hours before surgery.', 'armGroupLabels': ['Control Group']}, {'name': 'Carbohydrate Drink', 'type': 'OTHER', 'description': 'Group A participants will receive 400 mL of a commercially available clear carbohydrate-rich drink orally, two hours before surgery.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25700', 'city': 'Erzurum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Miraç Selcen Özkal Yalın, Doctor', 'role': 'CONTACT', 'email': 'miracselcen@hotmail.com', 'phone': '905393849811'}], 'facility': 'Ataturk University Research Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Ayşenur Dostbil, Proffessor', 'role': 'CONTACT', 'email': 'adostbil@hotmail.com', 'phone': '+905333676696'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr.', 'investigatorFullName': 'Aysenur Dostbil', 'investigatorAffiliation': 'Ataturk University'}}}}