Fentanyl and Propofol for Tracheal Intubation During Sevoflurane Induction Without Muscle Relaxants in Children

NCT02442128 | Completed DMC

• 1 other identifier: E-14-1071
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Intubation Complication

Keywords

Fentany; intubation; sevoflurane; children; Propofol

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• The hemodynamic response

  15 minutes

• The duration of intubation

  during endotracheal intubation (30 seconds)

• number of intubation attempts

  5 minutes

• occurrence of complication

  1 day

Study Arms (2)

Group1

ACTIVE COMPARATOR

comparison of different dosages of drugs ( Fentanyl / Propofol), fentanyl 2 μg/kg and propofol 2 mg/kg Both test drugs will be made up to 10 ml with saline. fentanyl will be first administered intravenously over 30 s followed by propofol over 20 s.

Drug: propofol /Fentanyl; Drug: Fentanyl / propofol

Group 2

ACTIVE COMPARATOR

comparison of different dosages of drug ( Fentanyl / Propofol) ,fentanyl 2 μg/kg and propofol 3 mg/kg. Both test drugs will be made up to 10 ml with saline. fentanyl will be first administered intravenously over 30 s followed by propofol over 20 s.

Drug: propofol /Fentanyl; Drug: Fentanyl / propofol

Interventions

propofol /Fentanyl DRUG

fentanyl 2 μg/kg and propofol 2 mg/kg Both test drugs will be made up to 10 ml with saline. fentanyl will be first administered intravenously over 30 s followed by propofol over 20 s.

Also known as: Fentanyl, Diprivan

Group 2; Group1

Fentanyl / propofol DRUG

fentanyl 2 μg/kg and propofol 3 mg/kg. Both test drugs will be made up to 10 ml with saline. fentanyl will be first administered intravenously over 30 s followed by propofol over 20 s.

Also known as: Fentanyl, Diprivan

Group 2; Group1

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I and II patients, Undergoing elective ENT surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, 11411, Saudi Arabia

Location

MeSH Terms

Interventions

Propofol; Fentanyl

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ashraf A Abdelhalim, MD

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 2, 2015
• First Posted: May 13, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

SA (1)