- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03134547
A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
A Comparison of Postoperative Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block in Children: Randomised Comparison of Two Dose
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After approval Institutional Review Board of our institute, informed consent was obtained from the parents of all pediatric patients. 40 children, aged up to 5 yr, undergoing elective subumbilical surgery were enrolled. Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study. By a computer generated schedule, children were randomized to either the low dose (1.0%) end tidal concentration of sevoflurane group (Group LS) or the high dose (2.5%) end tidal concentration of sevoflurane group (Group HS). The patients were sedated with intravenous ketamine 2 mg/kg and midazolam 0.05 mg/kg at waiting room and checked the loss of response to verbal or gentle touch. Then the patients were into the operating room, applied electrocardiography (ECG), pulse oximetry, and noninvasive blood pressure. Respiratory rate and end tidal carbon dioxide (CO2) were monitored via face mask. After baseline vital signs were monitored, the patient was posed in lateral Sims position, and 1 ml/kg lidocaine 1% with 5 μg/ml epinephrine was injected into the caudal space using a 22 G needle under 100% oxygen with each sevoflurane concentration according to group through a face mask. All of these procedures were performed by one skilled anesthesiologist who blinded about the study group. After caudal block was performed, the patients were returned in supine position, and maintained on spontaneous ventilation under 100% oxygen and each sevoflurane concentration according to group via face mask to conduct sedation during operation. If oxygen saturation decreases lesser than 90% due to over sedation or breathe holding caused by procedural pain, ventilation was assisted. If analgesia was insufficient for operation, fentanyl 0.5-1 μg/kg was administrated properly.
In the postanesthetic care unit (PACU), the investigators observed EA episodes at 5 and 30 min after PACU arrival using Four-point agitation scale and Pediatric Anesthesia Emergence Delirium (PAED) scale, and if a total score of PAED scale is higher than 15, which is prescribed a severe agitation, and then propofol 0.5 mg/kg was administered. EA was considered as an Four-point agitation scale > 3 or PAED scale > 10.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients undergoing elective subumbilical surgery, American society of anesthesiologist physical status classification 1
Exclusion Criteria:
- Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: low volume volatile anesthetics
1.0 % sevoflurane sedation via face mask , low dose sevoflurane group
|
low volume volatile anesthetics (1.0%)
Other Names:
|
Active Comparator: high volume volatile anesthetics
2.5 % sevoflurane sedation via face mask, high dose sevoflurane group
|
high volume volatile anesthetics (2.5%)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative agitation score
Time Frame: 5 minutes in the recovery room
|
Four-point agitation scale
|
5 minutes in the recovery room
|
postoperative agitation score
Time Frame: 30 minutes in the recovery room
|
Four-point agitation scale
|
30 minutes in the recovery room
|
postoperative agitation score
Time Frame: 5 minutes in the recovery room
|
Pediatric Anesthesia Emergence Delirium (PAED) scale
|
5 minutes in the recovery room
|
postoperative agitation score
Time Frame: 30 minutes in the recovery room
|
Pediatric Anesthesia Emergence Delirium (PAED) scale
|
30 minutes in the recovery room
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eun kyung Choi, MD,PhD, Yeungnam University Hospital
Publications and helpful links
General Publications
- Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
- Aono J, Ueda W, Mamiya K, Takimoto E, Manabe M. Greater incidence of delirium during recovery from sevoflurane anesthesia in preschool boys. Anesthesiology. 1997 Dec;87(6):1298-300. doi: 10.1097/00000542-199712000-00006.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dyskinesias
- Psychomotor Disorders
- Delirium
- Psychomotor Agitation
- Emergence Delirium
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Sevoflurane
Other Study ID Numbers
- YUMC 2017-04-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emergence Agitation
-
Prince of Songkla UniversityCompletedEmergence Agitation, Post Operative Behavioral ChangesThailand
-
Cairo Universityanesthesia department; Faculty of MedicineUnknownEmergence Delirium | Postopertive Delirium | Emergence Agitation in ChildrenEgypt
-
University of Medicine and Dentistry of New JerseyNintendo of North AmericaCompletedPediatric Emergence Agitation and PainUnited States
-
Suez Canal UniversityCompletedDelayed Emergence From AnesthesiaEgypt
-
Kuwait Specialized Eye CenterUnknownEmergence Agitation After Desflurane AnesthesiaKuwait
-
Seoul National University Bundang HospitalCompletedAgitation,PsychomotorKorea, Republic of
-
Lili JiaRecruitingGeneral Anesthetics,Emergence AgitationChina
-
Assiut UniversityCompletedAgitation, EmergenceEgypt
-
Assiut UniversityCompleted
-
Zagazig UniversityCompleted
Clinical Trials on low dose sevoflurane group
-
Newish Technology (Beijing) Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruitingHepatocellular CarcinomaChina
-
Tasly Pharmaceutical Group Co., LtdNot yet recruiting
-
Advenchen Pharmaceuticals, LLC.RecruitingSmall Cell Lung CancerUnited States
-
Shineway Pharmaceutical Co.,LtdUnknown
-
GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsUnknown
-
Anterogen Co., Ltd.TerminatedPerianal Fistula | Primary; ComplexKorea, Republic of
-
Maternal and Child Health Hospital of FoshanCompleted
-
Maternal and Child Health Hospital of FoshanWithdrawn
-
Tasly Pharmaceutical Group Co., LtdRecruitingChronic Heart Failure With Reduced Ejection FractionChina
-
Tasly Pharmaceutical Group Co., LtdRecruiting