Post Extubation Delirium and End-tidal Sevoflurane Concentration

Delirium on Emergence Clinical Trial

Official title:

Association Between Post Extubation Delirium and Pre-extubation End-tidal Sevoflurane Concentration in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489734
• Other study ID #: EDETSC
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: August 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium on Emergence
• Emergence Delirium

Intervention

Drug:
• sevoflurane
extubation when end-tidal concentration of sevoflurane < 0.5%
• Sevoflurane
extubation when end-tidal concentration of sevoflurane >= 0.5%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 30 minutes after awakening