Post Extubation Delirium and End-tidal Sevoflurane Concentration
Primary Purpose
Delirium on Emergence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sevoflurane
Sevoflurane
Sponsored by
About this trial
This is an interventional prevention trial for Delirium on Emergence focused on measuring sevoflurane, emergence delirium, preschool
Eligibility Criteria
Inclusion Criteria:
- Age 2-7 years
- ASA I - II
- Estimated surgery time < 2 hours
- Sevoflurane induction and maintenance along with caudal block or Axillary Block
Exclusion Criteria:
- Craniofacial anomalies
- Difficult exposure of the vocal cordS
- Obesity
- Asthma
- Invalid caudal block or axillary block
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
low concentration (LC)
high concentration (HC)
Arm Description
low concentration group
high concentration group
Outcomes
Primary Outcome Measures
Number of Participants With Emergence Delirium (ED)
The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score >12. Higher score of PAED means a worse outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT02489734
First Posted
June 16, 2015
Last Updated
July 27, 2021
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT02489734
Brief Title
Post Extubation Delirium and End-tidal Sevoflurane Concentration
Official Title
Association Between Post Extubation Delirium and Pre-extubation End-tidal Sevoflurane Concentration in Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.
Detailed Description
Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine spray on vocal cord. After that, an effective caudal or brachial plexus block was performed. End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when extubating >=0.5%) and low concentration group (Group LC, end-tidal concentration of sevoflurane when extubating <0.5%). Patients in Group LC were extubated when they coughed or purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane >= 0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met: 1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in PACU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium on Emergence
Keywords
sevoflurane, emergence delirium, preschool
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low concentration (LC)
Arm Type
Experimental
Arm Description
low concentration group
Arm Title
high concentration (HC)
Arm Type
Experimental
Arm Description
high concentration group
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
extubation when end-tidal concentration of sevoflurane < 0.5%
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
extubation when end-tidal concentration of sevoflurane >= 0.5%
Primary Outcome Measure Information:
Title
Number of Participants With Emergence Delirium (ED)
Description
The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score >12. Higher score of PAED means a worse outcome.
Time Frame
within 30 minutes after awakening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 2-7 years
ASA I - II
Estimated surgery time < 2 hours
Sevoflurane induction and maintenance along with caudal block or Axillary Block
Exclusion Criteria:
Craniofacial anomalies
Difficult exposure of the vocal cordS
Obesity
Asthma
Invalid caudal block or axillary block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuan Wang
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Post Extubation Delirium and End-tidal Sevoflurane Concentration
We'll reach out to this number within 24 hrs