Post Extubation Delirium and End-tidal Sevoflurane Concentration

NCT02489734 | Completed Results

• 1 other identifier: EDETSC
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium on Emergence

Keywords

sevoflurane; emergence delirium; preschool

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

low concentration (LC)

EXPERIMENTAL

low concentration group

Drug: sevoflurane

high concentration (HC)

EXPERIMENTAL

high concentration group

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

extubation when end-tidal concentration of sevoflurane \< 0.5%

low concentration (LC)

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2-7 years
• ASA I - II
• Estimated surgery time \< 2 hours
• Sevoflurane induction and maintenance along with caudal block or Axillary Block

You may not qualify if:

• Craniofacial anomalies
• Difficult exposure of the vocal cordS
• Obesity
• Asthma
• Invalid caudal block or axillary block

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Limitations and Caveats

First, the patients might have experienced pain in the PACU. However, distinguishing ED from pain in the PACU could be difficult. Second, we did not observe the duration of each case of ED.

Results Point of Contact

• Title: Dr. Xuan Wang
• Organization: Children's Hospital of Fudan University

13818318679@139.com

021-18017591058

Study Officials

• Xuan Wang

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: July 3, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 19, 2021
• Results First Posted: August 19, 2021

Record last verified: 2020-08