Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT05777135
Status:
UNKNOWN
Last Update Posted:
2023-04-05
First Post:
2023-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ringer Lactate Preloading on Induction Dose Requirement of Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-03-18', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propofol dose Required (mg)', 'timeFrame': 'Standard dosing in Operation', 'description': 'Propofol dose (mg) with aspect to weight (kg)'}, {'measure': 'Total Propofol dose given (mg)', 'timeFrame': 'Visualization of loss of eyelash reflex', 'description': 'Propofol dose (mg)'}, {'measure': 'Loss of eyelash reflex (seconds)', 'timeFrame': 'Propofol given till loss of eyelash reflex', 'description': 'Visualization of loss of eyelash reflex (seconds)'}], 'secondaryOutcomes': [{'measure': 'Units of Measure (e.g., weight and height)', 'timeFrame': 'Preanaesthetic checkup, Day 1', 'description': 'Weight in kilograms, height in meters ( weight and height will be combined to report BMI in kg/m²).'}, {'measure': 'Heart rate (beats / minute): After IV Propofol', 'timeFrame': 'Immediately After IV Propofol', 'description': 'Heart rate (beats / minute) will be measured with pulse oxymeter'}, {'measure': 'Heart rate (beats / minute): Baseline before IV fluid infusion', 'timeFrame': 'Base line Before IV fluid infusion', 'description': 'Heart rate (beats / minute) will be measured with pulse oxymeter'}, {'measure': 'Heart rate (beats / minute): At intubation (0 minute)', 'timeFrame': 'At intubation (0 minute)', 'description': 'Heart rate (beats / minute) will be measured with pulse oxymeter'}, {'measure': 'Heart rate (beats / minute): Post intubation (1 minute)', 'timeFrame': 'Post intubation (1 minute)', 'description': 'Heart rate (beats / minute) will be measured with pulse oxymeter'}, {'measure': 'Heart rate (beats / minute): Post intubation (3 minute)', 'timeFrame': 'Post intubation (3 minute)', 'description': 'Heart rate (beats / minute) will be measured with pulse oxymeter'}, {'measure': 'Heart rate (beats / minute): Post intubation (5 minute)', 'timeFrame': 'Post intubation (5 minute)', 'description': 'Heart rate (beats / minute) will be measured with pulse oxymeter'}, {'measure': 'Heart rate (beats / minute): Post intubation (10 minute)', 'timeFrame': 'Post intubation (10 minute)', 'description': 'Heart rate (beats / minute) will be measured with pulse oxymeter'}, {'measure': 'Systolic blood pressure (mm Hg): Baseline before IV fluid infusion', 'timeFrame': 'Baseline before IV fluid infusion', 'description': 'Systolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Systolic blood pressure (mm Hg): After IV Propofol', 'timeFrame': 'Immediately After IV Propofol', 'description': 'Systolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Systolic blood pressure (mm Hg): At intubation (0 minute)', 'timeFrame': 'At intubation (0 minute)', 'description': 'Systolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Systolic blood pressure (mm Hg): Post intubation (1 minute)', 'timeFrame': 'Post intubation (1 minute)', 'description': 'Systolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Systolic blood pressure (mm Hg): Post intubation (3 minute)', 'timeFrame': 'Post intubation (3 minute)', 'description': 'Systolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Systolic blood pressure (mm Hg): Post intubation (5 minute)', 'timeFrame': 'Post intubation (5 minute)', 'description': 'Systolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Systolic blood pressure (mm Hg): Post intubation (10 minute)', 'timeFrame': 'Post intubation (10 minute)', 'description': 'Systolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Diastolic blood pressure (mm Hg): Baseline before IV fluid infusion', 'timeFrame': 'Baseline before IV fluid infusion', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Diastolic blood pressure (mm Hg): After IV Propofol', 'timeFrame': 'Immediately After IV Propofol', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Diastolic blood pressure (mm Hg): At intubation (0 minute)', 'timeFrame': 'At intubation (0 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Diastolic blood pressure (mm Hg): Post intubation (1 minute)', 'timeFrame': 'Post intubation (1 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Diastolic blood pressure (mm Hg): Post intubation (3 minute)', 'timeFrame': 'Post intubation (3 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Diastolic blood pressure (mm Hg): Post intubation (5 minute)', 'timeFrame': 'Post intubation (5 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Diastolic blood pressure (mm Hg): Post intubation (10 minute)', 'timeFrame': 'Post intubation (10 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Mean arterial pressure (mm Hg): After IV Propofol', 'timeFrame': 'Immediately After IV Propofol', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Mean arterial pressure (mm Hg): Baseline before IV fluid infusion', 'timeFrame': 'Baseline before IV fluid infusion', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Mean arterial pressure (mm Hg): At intubation (0 minute)', 'timeFrame': 'At intubation (0 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Mean arterial pressure (mm Hg): Post intubation (1 minute)', 'timeFrame': 'Post intubation (1 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Mean arterial pressure (mm Hg): Post intubation (3 minute)', 'timeFrame': 'Post intubation (3 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Mean arterial pressure (mm Hg): Post intubation (5 minute)', 'timeFrame': 'Post intubation (5 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}, {'measure': 'Mean arterial pressure (mm Hg): Post intubation (10 minute)', 'timeFrame': 'Post intubation (10 minute)', 'description': 'Diastolic blood pressure (mm Hg) will be recorded on vital monitor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', "Ringer's Lactate"]}, 'referencesModule': {'references': [{'pmid': '7943815', 'type': 'RESULT', 'citation': 'Smith I, White PF, Nathanson M, Gouldson R. Propofol. An update on its clinical use. Anesthesiology. 1994 Oct;81(4):1005-43. No abstract available.'}, {'pmid': '8214693', 'type': 'RESULT', 'citation': 'Hug CC Jr, McLeskey CH, Nahrwold ML, Roizen MF, Stanley TH, Thisted RA, Walawander CA, White PF, Apfelbaum JL, Grasela TH, et al. Hemodynamic effects of propofol: data from over 25,000 patients. Anesth Analg. 1993 Oct;77(4 Suppl):S21-9.'}, {'pmid': '3257362', 'type': 'RESULT', 'citation': 'Van Aken H, Meinshausen E, Prien T, Brussel T, Heinecke A, Lawin P. The influence of fentanyl and tracheal intubation on the hemodynamic effects of anesthesia induction with propofol/N2O in humans. Anesthesiology. 1988 Jan;68(1):157-63. doi: 10.1097/00000542-198801000-00031. No abstract available.'}, {'pmid': '6978144', 'type': 'RESULT', 'citation': 'Briggs LP, Dundee JW, Bahar M, Clarke RS. Comparison of the effect of diisopropyl phenol (ICI 35, 868) and thiopentone on response to somatic pain. Br J Anaesth. 1982 Mar;54(3):307-11. doi: 10.1093/bja/54.3.307.'}, {'pmid': '3259081', 'type': 'RESULT', 'citation': 'McCollum JS, Milligan KR, Dundee JW. The antiemetic action of propofol. Anaesthesia. 1988 Mar;43(3):239-40. doi: 10.1111/j.1365-2044.1988.tb05551.x.'}, {'pmid': '10320158', 'type': 'RESULT', 'citation': "Williams EL, Hildebrand KL, McCormick SA, Bedel MJ. The effect of intravenous lactated Ringer's solution versus 0.9% sodium chloride solution on serum osmolality in human volunteers. Anesth Analg. 1999 May;88(5):999-1003. doi: 10.1097/00000539-199905000-00006."}]}, 'descriptionModule': {'briefSummary': '* To compare the effect (heart rate and mean arterial pressure) of Ringer Lactate preloading and without preloading on induction dose requirement of Propofol.\n* The Propofol requirement for induction dose with respect to loss of eyelash reflex in Ringer Lactate preloaded versus control group.', 'detailedDescription': '1. From the operation list, patients that meet the Inclusion criteria will be selected. (n=60)\n2. Patients will be allocated into two participant groups. Group I and Group II respectively using Simple random sampling technique by Ballot method. Ballot method is to keep the list of patients that meet the inclusion criteria in two ballot box mentioning name and groups and do the lottery based selection for both groups and Patient code will be given.\n3. Group I (n = 30) Preloading with Ringer Lactate 30 ml/kg over 30 mins prior to surgery will be done and Propofol dose (2mg / kg ) requirement for induction of anaesthesia will be noted.\n\n Group II (n = 30) No Preloading will be done and Propofol dose (2mg / kg) requirement for induction of anaesthesia will be noted.\n4. Then, investigators will visualize for loss of eyelash reflex in both groups.\n5. The hemodynamic response (heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure) to intubation between the two participant groups will be noted. The total Propofol requirement for induction in Ringer Lactate preloaded versus control group will be recorded.\n6. Drug administration and parameters recording will be done by the anaesthesiologist / under supervision'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients scheduled for elective surgeries\n2. American Society of Anaesthesiologists (ASA) class I patients\n3. Age between 18-45 years\n4. Any surgery under general anaesthesia requiring endotracheal intubation\n5. Body mass index (BMI) -18.5 - 24.9\n6. Those providing written consent\n\nExclusion Criteria:\n\n1. Emergency surgery\n2. Patients with multiple injuries, pregnancy\n3. Airway Mallampati grade II, III and IV\n4. Allergy to Ringer Lactate and Propofol.'}, 'identificationModule': {'nctId': 'NCT05777135', 'briefTitle': 'Ringer Lactate Preloading on Induction Dose Requirement of Propofol', 'organization': {'class': 'OTHER', 'fullName': 'National Medical College Birgunj'}, 'officialTitle': 'Effect of Ringer Lactate Preloading on Induction Dose Requirement of Propofol and Its Haemodynamic Stability at a Tertiary Center', 'orgStudyIdInfo': {'id': '519 - 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (Preloading with Ringer Lactate)', 'description': 'Preloading with Ringer lactate 30ml/kg over 30 minutes prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted', 'interventionNames': ['Drug: Ringer Lactate prior to surgery and Propofol']}, {'type': 'NO_INTERVENTION', 'label': 'Group II (No preloading)', 'description': 'No preloading will be done and Propofol dose requirement for induction of anaesthesia will be noted'}], 'interventions': [{'name': 'Ringer Lactate prior to surgery and Propofol', 'type': 'DRUG', 'otherNames': ['Ringer Lactate group'], 'description': 'Ringer Lactate prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted', 'armGroupLabels': ['Group I (Preloading with Ringer Lactate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44300', 'city': 'Birgunj', 'state': 'Madhesh', 'status': 'RECRUITING', 'country': 'Nepal', 'contacts': [{'name': 'Dr Arushi Jaiswal', 'role': 'CONTACT', 'email': 'arushij.dr16@gmail.com', 'phone': '+9779841675096'}], 'facility': 'National Medical College Teaching Hospital', 'geoPoint': {'lat': 27.01709, 'lon': 84.8808}}], 'centralContacts': [{'name': 'Dr Arushi Jaiswal', 'role': 'CONTACT', 'email': 'arushij.dr16@gmail.com', 'phone': '+9779841675096'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical College Birgunj', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Doctor', 'investigatorFullName': 'Arushi Jaiswal', 'investigatorAffiliation': 'National Medical College Birgunj'}}}}