Post Extubation Delirium and End-tidal Sevoflurane Concentration

Not Applicable

Completed

• Conditions: Delirium on Emergence
• Interventions: Drug: Sevoflurane

• Registration Number: NCT02489734
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2015-06-16
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2020-08
• Results First Submitted: 2020-08-19
• Results First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Results First Posted: 2021-08-19
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low concentration (LC)	Sevoflurane	low concentration group
high concentration (HC)	Sevoflurane	high concentration group

Primary Outcome Measures

Name	Time	Method
Number of Participants With Emergence Delirium (ED)	within 30 minutes after awakening	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.