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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442128
• Other study ID #: E-14-1071
• Status: Completed
• Phase: N/A
• First received: May 2, 2015
• Last updated: November 6, 2016
• Start date: June 2015
• Est. completion date: September 2016

Study information

• 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

Clinical Trial 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.

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

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Muscle Hypotonia

Intervention

Drug:
• propofol /Fentanyl
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.
• 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.

Locations

Country	Name	City	State
Saudi Arabia	King Saud University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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