Propofol-sevoflurane Induction for Pediatric Nasotracheal Intubation.
Nasotracheal Intubating Conditions With Reduced Pharmacologic Exposure After Propofol-sevoflurane Induction in Pediatric Parients: a Randomized Contolled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey (Türkiye), 34844
- Dragos Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- elective dental surgery ASA 1-3 Age 1-10
Exclusion Criteria:
- anticipated difficult intubation
- vocal cord pathology or disease
- hoarssness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Group R (research group)
pediatric patients in this group will be achieve sevoflurane inhalational+propofol intravenous anesthesia induction for nasotracheal intubation
|
patients in group R will undergo combination of sevoflurane and propofol only anesthesia induction
Other Names:
|
|
Active Comparator: group C (conventional group)
pediatric patients in this group will be achieve sevoflurane inhalational+propofol+fentanyl+rocuronium intravenous anesthesia induction for nasotracheal intubation
|
in group C, conventional anesthetic regimen will be used for anesthesia induction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intubating conditions
Time Frame: during direct laryngoscopy
|
the intubating score, based on GCRP guidelines, provides 3 levels of intubating conditions: poor, good and excellent.
'good' and 'excellent' conditions are considered as acceptable and are studied for two groups.
|
during direct laryngoscopy
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodynamic changes during intubation
Time Frame: T1- before induction T2 - immediately after induction
|
Mean arterial pressure (mmHg)
|
T1- before induction T2 - immediately after induction
|
|
postoperative side effects
Time Frame: immediately after extubation
|
laryngospasm (yes/no)
|
immediately after extubation
|
|
Hemodynamic changes during intubation
Time Frame: T1-before induction T2-immediately after induction
|
Systolic Blood Pressure (mmHg)
|
T1-before induction T2-immediately after induction
|
|
Hemodynamic changes during intubation
Time Frame: T1-before induction T2-immediately after induction
|
Diastolic blood pressure (mmHg)
|
T1-before induction T2-immediately after induction
|
|
Hemodynamic changes during intubation
Time Frame: T1-before induction T2-immediately after induction
|
Heart rate (/min)
|
T1-before induction T2-immediately after induction
|
|
postoperative side effects
Time Frame: immeiately after extubation
|
desaturation (SpO2<90%)
|
immeiately after extubation
|
|
postoperative side effects
Time Frame: immediately after extubation
|
sustained cough (yes/no)
|
immediately after extubation
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- Nkangarli003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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