1. Home
  2. Approved trials
  3. » فارسی

Tracheal intubation without muscle relaxant with Propofol or Sevoflurane in 2-7 year old children undergoing ear-nose-throat surgery

Protocol summary

Summary
Purpose: To compare intubation conditions and cardiovascular changes following induction of anesthesia and tracheal intubation in patients receiving either lidocaine-remifentanil-propofol or lidocaine-remifentanil-sevoflurane prior to induction. Methods: In a randomized, double-blind study 75 healthy children patients with these exclusion criteria: 1) cardiac disease, 2)asthma and any other pulmonary disease, 3)gastroesophagial reflux, 4)morbid obesity (BMI>30) , 5)difficult tracheal expected intubation were assigned to one of two groups: lidocaine 1.5 mg/kg, remifentanil 2 μg/kg and propofol 2 mg/kg (Group P) or lidocaine 1.5 mg/kg, remifentanil 2 μg/kg and sevoflurane (Group S). Then laryngoscopy and tracheal intubation were attempted at BIS 40-50. Intubation conditions were assessed as excellent, good or poor on the basis of ease of ventilation, position of the vocal cords, and patient’s response to intubation and slow inflation of the tracheal cuff. The mean arterial pressure (MAP) and heart rate (HR) were measured before anesthetic agent administration, immediately after tracheal intubation, and five minutes after intubation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102135822N1
Registration date: 2011-03-14, 1389/12/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-03-14, 1389/12/23
Registrant information
Name
Valiollah Hassani
Name of organization / entity
Department of Anesthesiology, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
valiollah_hassani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran university of medical scinces
Expected recruitment start date
2010-01-11, 1388/10/21
Expected recruitment end date
2011-01-11, 1389/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tracheal intubation without muscle relaxant with Propofol or Sevoflurane in 2-7 year old children undergoing ear-nose-throat surgery
Public title
Tracheal intubation without muscle relaxant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria): 1)age 2-7 years, 2)ENT & Eye surgery candidate. Exclusion Criteria): 1) cardiac disease, 2)asthma and any other pulmonary disease, 3)gastroesophagial reflux, 4)morbid obesity (BMI>30) , 5)difficult tracheal expected intubation.
Age
From 2 years old to 7 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran (previous Iran) university of medical sciences
Street address
Hemmat highway, between Sheikh Fazlollah and Chamran
City
Tehran
Postal code
Approval date
2009-12-07, 1388/09/16
Ethics committee reference number
1485631

Health conditions studied

1

Description of health condition studied
general anesthesia for ear-nose-throat surgery
ICD-10 code
H65.2
ICD-10 code description
Chronic serous otitis media

Primary outcomes

1

Description
the ease with which the patient is intubated
Timepoint
at the time of intubation (start of anesthesia)
Method of measurement
an scoring system measuring the ease/difficulty of intubation (scored by the anesthesiologist)

Secondary outcomes

1

Description
the ease of mask ventilation
Timepoint
after induction of general anesthesia
Method of measurement
an scoring system measuring the ease/difficulty of mask ventilation

2

Description
vocal cord position
Timepoint
at the time of tracheal intubation
Method of measurement
an scoring system measuring the vocal cord position by anesthesiologist

3

Description
the ease of laryngoscopy
Timepoint
at the time of laryngoscopy
Method of measurement
an scoring system measuring the ease/difficulty of laryngoscopy by anesthesiologist

4

Description
coughing
Timepoint
at the time of tracheal intubation
Method of measurement
an scoring system measuring the coughing by anesthesiologist

5

Description
blood pressure changes
Timepoint
before and at the time of intubation,5 min after intubation
Method of measurement
non invasive blood pressure monitoring

6

Description
heart rate changes
Timepoint
before and at the time of intubation,5 min after intubation
Method of measurement
ECG monitoring

Intervention groups

1

Description
intervention group: lidocaine 1.5 mg/kg, remifentanil 2 μg/kg and propofol 2mg/kg were injected intravenously
Category
Treatment - Drugs

2

Description
lidocaine 1.5 mg/kg intravenously and remifentanil 2 μg/kg intravenously injected and sevoflurane 3%MAC inhalationaly was added
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasul Akram hospital of tehran university of medical sciences
Full name of responsible person
Dr Valiollah Hassani
Street address
Niayesh street, Sattarkhan street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Doctor Akbar Fotouhi
Street address
Hemmat highway, between Sheikh Fazlollah and Chamran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Nazanin Mirabi
Position
anesthesiology assistant
Other areas of specialty/work
Street address
Rasul Akram complex, Niayesh street, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6651 6001
Fax
Email
nazaninmirabi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran univesity of medical sciences
Full name of responsible person
Dr. Valiollah Hassani
Position
professor of anesthesiology
Other areas of specialty/work
Street address
Rasul Akram Complex, Niayesh street, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6651 6001
Fax
Email
v-hassani@sina.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...