A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
Primary Purpose
Emergence Agitation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low dose sevoflurane group
high dose sevoflurane group
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Agitation focused on measuring emergence agitation, sevoflurane, children
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
low volume volatile anesthetics
high volume volatile anesthetics
Arm Description
1.0 % sevoflurane sedation via face mask , low dose sevoflurane group
2.5 % sevoflurane sedation via face mask, high dose sevoflurane group
Outcomes
Primary Outcome Measures
postoperative agitation score
Four-point agitation scale
postoperative agitation score
Four-point agitation scale
postoperative agitation score
Pediatric Anesthesia Emergence Delirium (PAED) scale
postoperative agitation score
Pediatric Anesthesia Emergence Delirium (PAED) scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03134547
First Posted
April 21, 2017
Last Updated
April 28, 2017
Sponsor
Yeungnam University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03134547
Brief Title
A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
Official Title
A Comparison of Postoperative Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block in Children: Randomised Comparison of Two Dose
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
February 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was performed to compare the incidence of EA between two dose of sevoflurane for sedation with caudal block in children, and intended to find the optimal dose for prevention of sevoflurane induced emergence agitation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
Keywords
emergence agitation, sevoflurane, children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low volume volatile anesthetics
Arm Type
Active Comparator
Arm Description
1.0 % sevoflurane sedation via face mask , low dose sevoflurane group
Arm Title
high volume volatile anesthetics
Arm Type
Active Comparator
Arm Description
2.5 % sevoflurane sedation via face mask, high dose sevoflurane group
Intervention Type
Drug
Intervention Name(s)
low dose sevoflurane group
Other Intervention Name(s)
1.0 %sevoflurane
Intervention Description
low volume volatile anesthetics (1.0%)
Intervention Type
Drug
Intervention Name(s)
high dose sevoflurane group
Other Intervention Name(s)
2.5% sevoflurane
Intervention Description
high volume volatile anesthetics (2.5%)
Primary Outcome Measure Information:
Title
postoperative agitation score
Description
Four-point agitation scale
Time Frame
5 minutes in the recovery room
Title
postoperative agitation score
Description
Four-point agitation scale
Time Frame
30 minutes in the recovery room
Title
postoperative agitation score
Description
Pediatric Anesthesia Emergence Delirium (PAED) scale
Time Frame
5 minutes in the recovery room
Title
postoperative agitation score
Description
Pediatric Anesthesia Emergence Delirium (PAED) scale
Time Frame
30 minutes in the recovery room
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun kyung Choi, MD,PhD
Organizational Affiliation
Yeungnam University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
15114210
Citation
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.
Results Reference
result
PubMed Identifier
9416712
Citation
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.
Results Reference
result
Learn more about this trial
A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
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