Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine (LR6)
Primary Purpose
Laryngospasm
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
NaCl 0,9%
Sponsored by
About this trial
This is an interventional prevention trial for Laryngospasm focused on measuring Anesthesia, Children, Larynx
Eligibility Criteria
Inclusion Criteria:
- 25 - 84 months
- gender: female / male
- elective surgery or diagnostic procedure requiring general anesthesia
Exclusion Criteria:
- respiratory infection within the last 2 weeks
- reactive airway disease under therapy
- cardiovascular disease
- neuromuscular disease
- positive family history of malignant hyperthermia
- known hypersensitivity to the investigational medical product
- Participation in another study
- Inability of the parents to read and understand the participant's information
Sites / Locations
- University children's hospital beider Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
larynx assessment under stimulation
Larynx assessment under stimulation
Arm Description
Outcomes
Primary Outcome Measures
Occurence of laryngospasm (defined as complete adduction of vocal cords and/or fals cords) with apnea lasting >10sec after laryngeal stimulation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01222169
Brief Title
Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine
Acronym
LR6
Official Title
Impact of Intravenous Lidocaine on Laryngeal Reflex Responses in Pediatric Patients Anesthetized With Propofol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Erb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children. To determine whether the co-administration of lidocaine blunts these reflex responses. The outcome of primary interest is the reflex laryngospasm.
Hypotheses:
I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv. administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol (3mcg/ml).
II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv. administration of lidocaine is equivalent to the response before the administration of lidocaine.
Detailed Description
Based on our previous work assessing the laryngeal reflex responses in children, the use of propofol appears to be promising regarding a low incidence of laryngospasm. Compared with a sevoflurane-based anesthesia, the incidence was found to be significantly lower, but there is a high incidence of other reflex responses, such as coughing and expiration reflexes. The use of lidocaine has been advocated to reduce the incidence of laryngospasm in anesthetized children. However, based on clinical studies its effectiveness in the prevention or attenuation of laryngospasm is controversial.
In a previous work using a established stimulation model (stimulating the laryngeal mucosa with a small amount of distilled water under direct fiberbronchoscopic observation), we observed a risk reduction of 60% of laryngospasm 2min. after the application of 2mg/kg bolus of lidocaine. This effect had already diminished after 10 min.
The laryngeal reflex responses differ largely in children anesthetized with either inhalational anesthetics or with propofol. The impact iv administered lidocaine on laryngeal and respiratory reflex responses in children anesthetized with propofol has not been assessed, although this combination might result in a profound suppression of laryngeal reflex responses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngospasm
Keywords
Anesthesia, Children, Larynx
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
larynx assessment under stimulation
Arm Type
Experimental
Arm Title
Larynx assessment under stimulation
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NaCl 0,9%
Other Intervention Name(s)
Propofol, Disoprivan, Recofol, Natriumchlorid
Intervention Description
Propofol 3micrgr/ml (TCI plasma concentration) and NaCl 0,9% 2min. and 10min. application
Primary Outcome Measure Information:
Title
Occurence of laryngospasm (defined as complete adduction of vocal cords and/or fals cords) with apnea lasting >10sec after laryngeal stimulation
Time Frame
10 min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Months
Maximum Age & Unit of Time
84 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
25 - 84 months
gender: female / male
elective surgery or diagnostic procedure requiring general anesthesia
Exclusion Criteria:
respiratory infection within the last 2 weeks
reactive airway disease under therapy
cardiovascular disease
neuromuscular disease
positive family history of malignant hyperthermia
known hypersensitivity to the investigational medical product
Participation in another study
Inability of the parents to read and understand the participant's information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas O Erb, Professor MD
Organizational Affiliation
University children's hospital beider Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University children's hospital beider Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine
We'll reach out to this number within 24 hrs