Anesthesia Intubation Complication Clinical Trial
Official title:
Using Fentanyl and Propofol for Tracheal Intubation During Sevoflurane Induction Without Muscle Relaxants in Children: a Randomized Prospective Study
Verified date | November 2016 |
Source | King Saud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Saudi Arabia: Ministry for Higher Education |
Study type | Interventional |
Several methods have been proposed to improve intubating conditions and minimize sevoflurane
induction time during sevoflurane induction in children. These include clonidine
premedication, [5] addition of nitrous oxide, [6] opioids, [7,8] or propofol [9].
Four Studies evaluated sevoflurane alone for intubation (9-12).Aim of this study: is to
evaluate the effects of two different dose of propofol preceded by a fixed dose of fentanyl
during sevoflurane induction on quality of tracheal intubation in children undergoing
elective surgery.
Status | Completed |
Enrollment | 90 |
Est. completion date | September 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Years to 6 Years |
Eligibility |
Inclusion Criteria: - ASA physical status I and II patients, Undergoing elective ENT surgery Exclusion Criteria: - • History or examination suggested a potentially difficult intubation, - Significant respiratory disease or poorly controlled asthma, - gastrooesophageal reflux, - neurological or neuromuscular disease, - any condition that would preclude the use of this technique, - known sensitivity to the drugs used, - history or examination suggestive of cardiac illness, - history of respiratory tract infection in the previous 2 weeks, - history of malignant hyperthermia or other myopathy, - who refused to undergo an inhalational induction, - Children in whom i.v. access had already been established. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Saud University | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Saud University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of excellent intubating conditions | Intubating conditions will be evaluated as proposed by Viby-Mogensen and colleagues . Five factors will be considered for assessment, jaw relaxation; ease of laryngoscopy; vocal cord position; coughing; and patient movement as excellent (1), good (2) or poor (3). Overall intubating conditions will be recorded as 'excellent' if all score 1, 'good' if any scored 2, and 'poor' if there will be any scores of 3. Intubation will not be attempted if the vocal cords is closed to avoid airway complications and any failure to intubate the trachea or prolonged coughing on intubation will be managed using suxamethonium or a non-depolarising muscle relaxant where clinically indicated. |
during start of endotracheal intubation (10 seconds) | No |
Secondary | The hemodynamic response | . In both groups HR, MAP and SPO2 will be measured immediately before the inhaled induction, after propofol administration, prior to intubation, immediately after intubation and at 2 and 5min min after intubation. Occurrence of bradycardia, hypotension or other significant complication will be recorded. | 15 minutes | No |
Secondary | The duration of intubation | time between the initial introduction of the laryngoscope and the final placement of the tracheal tube | during endotracheal intubation (30 seconds) | No |
Secondary | number of intubation attempts | number of intubation attempts before successful intubation | 5 minutes | No |
Secondary | occurrence of complication | bradycardia, hypotension , laryngeal spasm, desaturation, stridor or other significant complication will be recorded. | 1 day | No |
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