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

Primary Purpose

Anesthesia Intubation Complication

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
propofol /Fentanyl
Fentanyl / propofol
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia Intubation Complication focused on measuring Fentany, intubation, sevoflurane, children, Propofol

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The duration of intubation
time between the initial introduction of the laryngoscope and the final placement of the tracheal tube
number of intubation attempts
number of intubation attempts before successful intubation
occurrence of complication
bradycardia, hypotension , laryngeal spasm, desaturation, stridor or other significant complication will be recorded.

Full Information

First Posted
May 2, 2015
Last Updated
November 6, 2016
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT02442128
Brief Title
Fentanyl and Propofol for Tracheal Intubation During Sevoflurane Induction Without Muscle Relaxants in Children
Official Title
Using Fentanyl and Propofol for Tracheal Intubation During Sevoflurane Induction Without Muscle Relaxants in Children: a Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
All patients fasted 6 h for solid food, but clear fluids will be given for up to 4 h pre- operatively. All patients will be pre-medicated with 0.3 mg/kg oral midazolam (maximum dose of 12 mg) 30 min before induction and EMLA cream will be applied to the dorsum of both hands 1 h prior to surgery. Children who refuse to take oral premedication will be excluded. One parent will be allowed to accompany the child into the pre-operative holding area. On arrival in the anesthetic room, baseline heart rate, pulse oximeter oxygen saturation and non-invasive blood pressure will be measured. A side-stream connector for the measurement of end-tidal sevoflurane concentration and end-tidal carbon dioxide will be introduced between the face mask and a Mapelson D breathing system. Anesthesia will be induced by a circle system using a vaporizer concentration of 6% sevoflurane in an oxygen flow of 6 L/min. After loss of consciousness and the eyelash reflex, sevoflurane concentration will be reduced to 3 % and intravenous access will be secured in all children using a 22-G cannula sited on the dorsum of a hand and the facemask ventilation will be then assisted using a 10 cm H2O inspiratory pressure at a ventilatory frequency of 16min. Once IV cannula is administered the inspired concentration of sevoflurane was decreased to 1% in oxygen. The investigating anesthetist will open a sealed envelope allocating the patient to one of two groups: Group 1 = fentanyl 2 μg/kg and propofol 2 mg/kg or Group 2 = fentanyl 2 μg/kg and propofol 3 mg/kg. Both test drugs will be made up to 10 ml with saline. In both groups, fentanyl will be first administered intravenously over 30 s followed by propofol over 20 s. Ninety seconds after administration of propofol, laryngoscopy and tracheal intubation with an appropriate sized non cuffed tube will be performed using a suitable sized Macintosh laryngoscope by a second an experienced unbiased anesthetist who enters the room and, unaware of the patient's randomization group. Intubating conditions will be evaluated as proposed by Viby-Mogensen and colleagues [9]. 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. Following successful tracheal intubation, the study will be ended at this point, ventilation will be gently assisted and anesthesia will be maintained at the discretion of the anesthesiologist. 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. The first investigating anesthetist is unblinded and responsible for preparing and administering all drugs. The second anesthetist will be blinded to drug allocation, intubate patients, record all parameters, and grade the airway conditions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Intubation Complication
Keywords
Fentany, intubation, sevoflurane, children, Propofol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
propofol /Fentanyl
Other Intervention Name(s)
Fentanyl, Diprivan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl / propofol
Other Intervention Name(s)
Fentanyl, Diprivan
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of excellent intubating conditions
Description
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.
Time Frame
during start of endotracheal intubation (10 seconds)
Secondary Outcome Measure Information:
Title
The hemodynamic response
Description
. 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.
Time Frame
15 minutes
Title
The duration of intubation
Description
time between the initial introduction of the laryngoscope and the final placement of the tracheal tube
Time Frame
during endotracheal intubation (30 seconds)
Title
number of intubation attempts
Description
number of intubation attempts before successful intubation
Time Frame
5 minutes
Title
occurrence of complication
Description
bradycardia, hypotension , laryngeal spasm, desaturation, stridor or other significant complication will be recorded.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf A Abdelhalim, MD
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11411
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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