Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT03672734
Status:
UNKNOWN
Last Update Posted:
2019-04-04
First Post:
2018-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pH of Gastric Contents', 'timeFrame': '6 hours', 'description': 'After general anesthesia, the investigator will insert an orogastric tube to drain the all the gastric secretion until the end of surgery. The pH of the content will be measured at the end of the operation.'}], 'secondaryOutcomes': [{'measure': 'Volume of Gastric Content', 'timeFrame': '6 hours', 'description': 'After general anesthesia, the investigator will insert an orogastric tube to drain the all the gastric secretion until the end of surgery. The volume of the content (mL.) will be measured at the end of the operation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pH gastric contents', 'laparoscopic surgery', 'pH stomach', 'volume gastric content'], 'conditions': ['General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '19512861', 'type': 'BACKGROUND', 'citation': 'Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.'}, {'pmid': '25442242', 'type': 'BACKGROUND', 'citation': 'Ouanes JP, Bicket MC, Togioka B, Tomas VG, Wu CL, Murphy JD. The role of perioperative chewing gum on gastric fluid volume and gastric pH: a meta-analysis. J Clin Anesth. 2015 Mar;27(2):146-52. doi: 10.1016/j.jclinane.2014.07.005. Epub 2014 Nov 28.'}, {'pmid': '25501720', 'type': 'BACKGROUND', 'citation': 'Schmidt AR, Buehler P, Seglias L, Stark T, Brotschi B, Renner T, Sabandal C, Klaghofer R, Weiss M, Schmitz A. Gastric pH and residual volume after 1 and 2 h fasting time for clear fluids in childrendagger. Br J Anaesth. 2015 Mar;114(3):477-82. doi: 10.1093/bja/aeu399. Epub 2014 Dec 13.'}, {'pmid': '26603797', 'type': 'BACKGROUND', 'citation': 'Phillips S, Liang SS, Formaz-Preston A, Stewart PA. High-risk residual gastric content in fasted patients undergoing gastrointestinal endoscopy: a prospective cohort study of prevalence and predictors. Anaesth Intensive Care. 2015 Nov;43(6):728-33. doi: 10.1177/0310057X1504300610.'}, {'pmid': '25125250', 'type': 'BACKGROUND', 'citation': 'Splinter WM. From the Journal archives: gastric fluid volume and pH in elective patients following unrestricted oral fluid until three hours before surgery. Can J Anaesth. 2014 Dec;61(12):1126-9. doi: 10.1007/s12630-014-0220-z. Epub 2014 Aug 15. No abstract available.'}, {'pmid': '25362513', 'type': 'BACKGROUND', 'citation': 'Goudra BG, Singh PM, Carlin A, Manjunath AK, Reihmer J, Gouda GB, Ginsberg GG. Effect of Gum Chewing on the Volume and pH of Gastric Contents: A Prospective Randomized Study. Dig Dis Sci. 2015 Apr;60(4):979-83. doi: 10.1007/s10620-014-3404-z. Epub 2014 Nov 2.'}, {'pmid': '23891', 'type': 'BACKGROUND', 'citation': 'Ong BY, Palahniuk RJ, Cumming M. Gastric volume and pH in out-patients. Can Anaesth Soc J. 1978 Jan;25(1):36-9. doi: 10.1007/BF03006781.'}, {'pmid': '15109187', 'type': 'BACKGROUND', 'citation': 'Gouda BB, Lydon AM, Badhe A, Shorten GD. A comparison of the effects of ranitidine and omeprazole on volume and pH of gastric contents in elective surgical patients. Eur J Anaesthesiol. 2004 Apr;21(4):260-4. doi: 10.1017/s0265021504004028.'}, {'pmid': '7955016', 'type': 'BACKGROUND', 'citation': 'Gombar S, Kiran S, Gupta M, Gombar K, Chhabra B. Preanaesthetic oral ranitidine, omeprazole and metoclopramide for modifying gastric fluid volume and pH. Can J Anaesth. 1994 Sep;41(9):879-80. doi: 10.1007/BF03011614. No abstract available.'}, {'pmid': '7999487', 'type': 'BACKGROUND', 'citation': 'Boulay K, Blanloeil Y, Bourveau M, Geay G, Malinovsky JM. Effects of oral ranitidine, famotidine and omeprazole on gastric volume and pH at induction and recovery from general anaesthesia. Br J Anaesth. 1994 Oct;73(4):475-8. doi: 10.1093/bja/73.4.475.'}, {'pmid': '2796624', 'type': 'BACKGROUND', 'citation': 'Chang KK, Jawan B, Fung ST, Lee JH. Effect of preoperative fasting time on gastric volume and pH. Ma Zui Xue Za Zhi. 1989 Jun;27(2):149-52.'}, {'pmid': '1535490', 'type': 'BACKGROUND', 'citation': 'Haavik PE, Soreide E, Hofstad B, Steen PA. Does preoperative anxiety influence gastric fluid volume and acidity? Anesth Analg. 1992 Jul;75(1):91-4. doi: 10.1213/00000539-199207000-00017.'}, {'pmid': '2065409', 'type': 'BACKGROUND', 'citation': 'Maltby JR, Lewis P, Martin A, Sutheriand LR. Gastric fluid volume and pH in elective patients following unrestricted oral fluid until three hours before surgery. Can J Anaesth. 1991 May;38(4 Pt 1):425-9. doi: 10.1007/BF03007577.'}, {'pmid': '1875801', 'type': 'BACKGROUND', 'citation': 'Noakes TD, Rehrer NJ, Maughan RJ. The importance of volume in regulating gastric emptying. Med Sci Sports Exerc. 1991 Mar;23(3):307-13.'}, {'pmid': '19344341', 'type': 'BACKGROUND', 'citation': 'Goetze O, Treier R, Fox M, Steingoetter A, Fried M, Boesiger P, Schwizer W. The effect of gastric secretion on gastric physiology and emptying in the fasted and fed state assessed by magnetic resonance imaging. Neurogastroenterol Motil. 2009 Jul;21(7):725-e42. doi: 10.1111/j.1365-2982.2009.01293.x. Epub 2009 Apr 1.'}, {'pmid': '3630589', 'type': 'BACKGROUND', 'citation': 'Brocks K, Jensen JS, Schmidt JF, Jorgensen BC. Gastric contents and pH after oral premedication. Acta Anaesthesiol Scand. 1987 Jul;31(5):448-9. doi: 10.1111/j.1399-6576.1987.tb02600.x.'}]}, 'descriptionModule': {'briefSummary': "Complications during general anesthesia,induction period: difficult airway, hypotension, upper airway obstruction, laryngospasm, pulmonary aspiration Maintenance period: hypotension, hypertension, awareness, bronchospasm, pulmonary aspiration.\n\nEmergence period: delayed emergence, upper airway obstruction, pulmonary aspiration.\n\nPulmonary aspiration occur all ranges of general anesthesia. Because the patients can not protected themselves due to anesthetic medication, example: volatile agent, opioid.This can cause decrease consciousness, delayed gastric emptying time. Incidence of pulmonary aspiration was 1 : 900 - 1 : 10,000 of general of anesthesia (induction 20%, emergence 80%), Anesthesia Service in Siriraj Hospital (2017) 6: 25,000 case Pathophysiology of pulmonary aspiration.\n\nPulmonary aspiration is defined as inhalation of oropharynx or stomach contents through the larynx to low respiratory tract. Aspiration pneumonitis is the inflammation of the lung caused by aspirating or inhaling irritants (Mendelson's syndrome).\n\nGastric acid is a digestive fluid formed in the stomach and is composed of hydrochloric acid, potassium chloride, and sodium chloride.The highest concentration of gastric acid is 140-160 mEq/L. The pH of gastric acid is 1.5-3.5 in the human stomach lumen.\n\nRisk factors for increased gastric contents: full stomach, delayed gastric emptying, incompetent lower esophageal sphincter, lithotomy position, laparoscopy, length of surgery more than 2 hr., difficult airway.\n\nThis study observed Volume and pH of Gastric Contents in Patients undergoing Gynecologic Laparoscopic Surgery during Emergence from General Anesthesia.", 'detailedDescription': 'The study was approved from the Siriraj Institutional Review Board (Si-IRB), COA (Certificate of Analysis):Si437/2018 and was written informed consent was obtained from all subjects. The study was conducted at the Department of Siriraj Obstetrics and Gynecology.\n\nA total of 100 patients were enrolled in the study between September 2018 and 2019. All patients underwent general anesthesia for elective gynecologic laparoscopic surgery. Inclusion criteria were elective Cases, laparoscopic surgery, age 18-65 year,BMI\\<30kg/sq.m. Exclusion criteria were emergency Case, full stomach. Withdrawal or termination criterion was the difficult inserted orogastric tube.\n\nOn the day of surgery, participants signed the informed consent. Record data consisted of NPO time, premedication drug, BMI, having intravenous fluid. All patients underwent general anesthesia after application of standard monitors, anesthesia was induced with fentanyl 1-2 mcg/kg. or morphine 0.1-0.2 mg/kg., propofol 1.5-2.5 mg/kg.,nimbex 1-1.5 mg/kg or atracurium 0.6 mg/kg. Anesthesia was maintained with sevoflurane, air, o2.\n\nGastric volume and PH were measured with PH meter, measured at 1hr. intervals until the end of surgery. Intraoperative, record medication for reduced gastric volume or PH.\n\nPostoperative, data were record nausea or vomiting, medication requirements.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients underwent gynecologic laparoscopic surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA class 1-2,\n* 18-65 years old,\n* Laparoscopic surgery,\n* BMI\\<30kg/sq.m.\n\nExclusion Criteria:\n\n* Difficult inserted orogastric tube.'}, 'identificationModule': {'nctId': 'NCT03672734', 'briefTitle': 'Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'Observed Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia', 'orgStudyIdInfo': {'id': '328/2561(EC3)'}}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Waerunee Boayam', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Warunede Buayam, B.NS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Faculty of Medicine, Siriraj hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol university', 'investigatorFullName': 'Warunee Boayam', 'investigatorAffiliation': 'Siriraj Hospital'}}}}