Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-28 @ 11:41 PM
Study NCT ID:
NCT05420402
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Administrations of Propofol on Emergence Agitation in Preschool Children Undergoing Ambulatory Surgery
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-11', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of emergence agitation', 'timeFrame': 'Within up to 30 minutes after operation', 'description': 'Pediatric anesthesia emergence delirium scale (PAED). The total score is 20 points.A score of 10 or above is considered as EA and 15 or above is considered as severe EA.'}], 'secondaryOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': '1 day post surgery', 'description': 'The length of time the patient took from leaving the operating room to being discharged from the hospital.'}, {'measure': 'The occurrence of adverse reactions', 'timeFrame': 'Within up to 30 minutes after operation', 'description': 'These include both gastrointestinal and respiratory reactions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergence Agitation', 'Ambulatory Surgery', 'Preschool Children', 'Propofol'], 'conditions': ['Anesthesia', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '27792057', 'type': 'RESULT', 'citation': 'Fabricant PD, Seeley MA, Rozell JC, Fieldston E, Flynn JM, Wells LM, Ganley TJ. Cost Savings From Utilization of an Ambulatory Surgery Center for Orthopaedic Day Surgery. J Am Acad Orthop Surg. 2016 Dec;24(12):865-871. doi: 10.5435/JAAOS-D-15-00751.'}, {'pmid': '27083963', 'type': 'RESULT', 'citation': 'Shinnick JK, Short HL, Heiss KF, Santore MT, Blakely ML, Raval MV. Enhancing recovery in pediatric surgery: a review of the literature. J Surg Res. 2016 May 1;202(1):165-76. doi: 10.1016/j.jss.2015.12.051. Epub 2016 Jan 12.'}, {'pmid': '27798810', 'type': 'RESULT', 'citation': 'Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5.'}, {'pmid': '26601849', 'type': 'RESULT', 'citation': 'Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.'}, {'pmid': '22929729', 'type': 'RESULT', 'citation': "Jacob Z, Li H, Makaryus R, Zhang S, Reinsel R, Lee H, Feng T, Rothman DL, Benveniste H. Metabolomic profiling of children's brains undergoing general anesthesia with sevoflurane and propofol. Anesthesiology. 2012 Nov;117(5):1062-71. doi: 10.1097/ALN.0b013e31826be417."}, {'pmid': '26290263', 'type': 'RESULT', 'citation': "Chidambaran V, Costandi A, D'Mello A. Propofol: a review of its role in pediatric anesthesia and sedation. CNS Drugs. 2015 Jul;29(7):543-63. doi: 10.1007/s40263-015-0259-6."}, {'pmid': '30930979', 'type': 'RESULT', 'citation': 'Wu X, Cao J, Shan C, Peng B, Zhang R, Cao J, Zhang F. Efficacy and safety of propofol in preventing emergence agitation after sevoflurane anesthesia for children. Exp Ther Med. 2019 Apr;17(4):3136-3140. doi: 10.3892/etm.2019.7289. Epub 2019 Feb 20.'}, {'pmid': '25917689', 'type': 'RESULT', 'citation': "van Hoff SL, O'Neill ES, Cohen LC, Collins BA. Does a prophylactic dose of propofol reduce emergence agitation in children receiving anesthesia? A systematic review and meta-analysis. Paediatr Anaesth. 2015 Jul;25(7):668-76. doi: 10.1111/pan.12669. Epub 2015 Apr 27."}, {'pmid': '21726352', 'type': 'RESULT', 'citation': 'Malarbi S, Stargatt R, Howard K, Davidson A. Characterizing the behavior of children emerging with delirium from general anesthesia. Paediatr Anaesth. 2011 Sep;21(9):942-50. doi: 10.1111/j.1460-9592.2011.03646.x. Epub 2011 Jul 5.'}, {'pmid': '20497353', 'type': 'RESULT', 'citation': 'Bajwa SA, Costi D, Cyna AM. A comparison of emergence delirium scales following general anesthesia in children. Paediatr Anaesth. 2010 Aug;20(8):704-11. doi: 10.1111/j.1460-9592.2010.03328.x.'}, {'pmid': '40090678', 'type': 'DERIVED', 'citation': 'Chen J, Shi X, Hu W, Lin R, Meng L, Liang C, Ma X, Xu L. Comparing different administration methods of subanaesthetic propofol to mitigate emergence agitation in preschool children undergoing day surgery: a double-blind, randomised controlled study. BMJ Paediatr Open. 2025 Mar 15;9(1):e002376. doi: 10.1136/bmjpo-2023-002376.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the influence of different dose and methods of propofol on emergence agitation(EA) through a randomized controlled trial when preschool children undergoing ambulatory surgery of inguinal hernia.', 'detailedDescription': "Emergency agitation (EA) is the manifestation of excitement, high irritability, intense struggle, and increased blood pressure and heart rate during the recovery period of general anesthesia. It is a common adverse reaction after general anesthesia. The incidence in preschool children is 10%-80%, which is currently considered to be mainly related to factors such as the use of inhalation anesthetics, pain stimulation, drug types, surgical methods, and environmental changes. EA not only increases children's risks, such as drains and dehiscence, but also increases caregiver stress and reduces parental satisfaction with the method of anesthesia.\n\nThis trial is a randomized single-blind clinical trial. The padiatric patients were randomly divided into 4 groups.The block randomization is generated by statistical professionals using SAS9.2 software. The block size is fixed at 8 and randomly changed. Each random number and the corresponding assignment result are placed in a sealed in a transparent envelope. The investigator is responsible for including subjects according to the requirements of the program. When the subjects meet the inclusion criteria but not the exclusion criteria, the field staff will open the envelopes in order to group them.The clinical anesthesia and data statistical analysis were completed by different anesthesiologists and participants.\n\nThe four groups of children were fasted for 6 hours and 2 hours before operation, and no preoperative medication was given. After the children were awake and entered the room, the heart rate (HR), non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO2), respiratory rate (RR) and end-tidal carbon dioxide partial pressure (PetCO2) were continuously monitored. Both groups were given routine standard anesthesia induction: intravenous injection of midazolam at 0.05-0.1 mg/kg of predicted body weight (PBW), propofol at 2-4 mg/kg of PBW, and remifentanil at 1-2 ug/kg of PBW, rocuronium at 0.5-1mg/kg of PBW.After adequate pre-oxygenation,laryngeal mask was placed.Anesthesia was maintained by inhalation of 2%-3% sevoflurane and continuous pumping of remifentanil at 0.2-0.4ug/kg/min remifentanil, with an oxygen flow of 2L/min. The tidal volume method was used in all mechanical ventilation. The tidal volume was between 6 and 8 mL/kg, the respiratory rate was between 18 and 24 breaths/min, and the PetCO2 was maintained between 30 and 35 mmHg. Three minutes before the end of surgery, the oxygen flow was adjusted to 6 L/min, sevoflurane was stopped, and the infusion of remifentanil was stopped. At the end of the operation, the children in all groups received local infiltration anesthesia with 0.3% ropivacaine around the incision by the surgeon.\n\nThe children in group A were given 1 mg/kg propofol intravenous bolus 3 minutes before the end of the operation.Children in group B were given continuous pumping of 1 mg/kg propofol 3 minutes before the end of the operation, and the infusion time was 3 minutes. Children in group C 1 mg/kg propofol was given intravenously at the end of the operation. Children in group D were not given propofol and served as a blank control group.\n\nAll data were collected, aggregated and maintained by a single investigator.The primary outcome measure was the anesthesia emergence delirium scale (PAED). The observation was performed during the recovery period of the child, and the child opened his eyes voluntarily to the stage of complete recovery of consciousness. Mainly from the three aspects of eye contact, behavior and consciousness, the total score is 20 points. 15 points for severe agitation.In addition, the indicators we collected also include age, gender, weight, ASA classification, operation method, operation time, discharge time and occurrence of adverse reactions and so on.\n\nThe full analysis set was used for analysis. According to the basic principle of Intention-to-Treat (ITT), the analysis of the main indicators includes all randomized subjects, regardless of whether they completed the trial or not, that is, subjects who were lost to follow-up should also be included in the statistical analysis. Statistical software SPSS 26.0 was used for data processing and statistical analysis. Shapiro-Wilk test was first performed on the data, and continuous variable data (such as blood pressure, heart rate, driving pressure, oxygenation index, etc.) were determined to use Analysis of variance or Kruskal-Wallis H test according to their normal distribution. Categorical variables (such as age,incidence of EA, etc.) were tested by χ² test, Fisher's exact test, and the results were expressed as mean ± standard deviation (SD), percentage (%) or median (interquartile range, IQR), P \\<0.05 is statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 2-5 years\n* ASA classification 1\n* Written informed consent\n* Children undergoing ambulatory surgery of inguinal hernia\n* The operation will take no more than 20 minutes\n\nExclusion Criteria:\n\n* Allergic to drugs used in the study\n* Neurological disorders\n* Congenital heart insufficiency\n* Recent respiratory illness'}, 'identificationModule': {'nctId': 'NCT05420402', 'briefTitle': 'Effect of Different Administrations of Propofol on Emergence Agitation in Preschool Children Undergoing Ambulatory Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shantou University Medical College'}, 'officialTitle': 'Effect of Different Administrations of Propofol on Emergence Agitation in Preschool Children Undergoing Ambulatory Surgery', 'orgStudyIdInfo': {'id': 'SZanes0712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bolus group A', 'description': '42 participants will receive 1 mg/kg intravenous bolus of propofol 3 min before the end of surgery.', 'interventionNames': ['Drug: Propofol bolus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous infusion group', 'description': '42 participants will receive 1 mg/kg continuous intravenous pumping of propofol 3 minutes before the end of the operation, and the pumping time was 3 minutes.', 'interventionNames': ['Drug: Propofol continuous infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bolus group B', 'description': '42 participants will receive 1 mg/kg intravenous bolus of propofol at the end of surgery.', 'interventionNames': ['Drug: Propofol bolus']}, {'type': 'NO_INTERVENTION', 'label': 'Blank Comparator group', 'description': '42 participants will not receive propofol'}], 'interventions': [{'name': 'Propofol bolus', 'type': 'DRUG', 'otherNames': ['3 minutes before the end of the surgery'], 'description': 'A bolus dose of propofol 1 mg/kg was administered intravenously at 3 minutes before the end of the surgery.', 'armGroupLabels': ['Bolus group A']}, {'name': 'Propofol continuous infusion', 'type': 'DRUG', 'otherNames': ['3 min intravenous pumping'], 'description': '1 mg/kg propofol was started by continuous infusion 3 minutes before the end of surgery, and the infusion time was 3 minutes.', 'armGroupLabels': ['Continuous infusion group']}, {'name': 'Propofol bolus', 'type': 'DRUG', 'otherNames': ['at the end of the surgery'], 'description': 'A bolus dose of propofol 1 mg/kg was administered intravenously at the end of the surgery.', 'armGroupLabels': ['Bolus group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518038', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen Children's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication and with no end date', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal To achieve aims in the approved proposal.\n\nProposals should be directed to Dr Jiaxiang Chen; e-mail address:cjxanes@163.com\n\nTo gain access, data requestors will need to sign a data Access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiaxiang Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jiaxiang Chen', 'investigatorAffiliation': 'Shantou University Medical College'}}}}