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Comparison of sufentanil and remifentanil in combination with propofol to facilitate use of supraglottic airway devices

Protocol summary

Summary
Purpose: The purpose of this study is to evaluate the effects of two narcotics, remifentanyl and sufentanyl on ease of insertion of two types of supraglottic airway devices. Plan: This is a randomized block, double-blind, without placebo and clinical trial phase II study. Inclusion criterion: patients who were candidates for elective surgery. Exclusion criteria: patients who were hemodynamically unstable, had a history of heart and respiratory disorders, required airway control by endotracheal intubation and those who may need to change position during surgery. The sample size in this study is 200. Interventions: Anesthesia induction was performed using propofol 2.5 mg kg for all patients and then 1st group received remifentanyl and laryngeal mask, 2nd group remifentanyl and SLIPA, 3rd group sufentanyl and laryngeal mask, and 4th group sufentanyl and SLIPA. Primary outcome: The amount of jaw opening, ease of insertion of supraglottic devices, cough, laryngospasm, and the gag reflex, heart rate and arterial blood pressure were recorded one, three, and five minutes after insertion of supraglottic devices.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110027686N1
Registration date: 2011-12-31, 1390/10/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-31, 1390/10/10
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 9793
Email address
dr.hemodir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences,Vice chancellor for research
Expected recruitment start date
2011-05-05, 1390/02/15
Expected recruitment end date
2011-10-07, 1390/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sufentanil and remifentanil in combination with propofol to facilitate use of supraglottic airway devices
Public title
Comparison of sufentanil and remifentanil in combination with propofol to facilitate use of supraglottic airway devices
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients who were candidates for elective surgery Exclusion criteria: hemodynamic instability; history of heart and respiratory disorders; required airway control by endotracheal intubation and need to change position during surgery
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 200
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
Ethical Committee of Arak University of Medical Sciences
Street address
Alamolhoda Ave, Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2011-05-04, 1390/02/14
Ethics committee reference number
89-81-2

Health conditions studied

1

Description of health condition studied
Tracheal intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation

Primary outcomes

1

Description
Blood Pressure
Timepoint
Before induction of anesthesia and one, three and five minutes after induction of anesthesia
Method of measurement
Blood pressure manometer

2

Description
Heart rate
Timepoint
Before induction of anesthesia and one, three and five minutes after induction of anesthesia
Method of measurement
Counting the heart rate in one minute

3

Description
Jaw Opening
Timepoint
One minute after induction of anesthesia
Method of measurement
variable was measured qualitatively by 3 grades: Full(3) Partial(2) Nil(1)

4

Description
Ease of supraglottic device insertion
Timepoint
One minute after induction of anesthesia
Method of measurement
variable was measured qualitatively by 3 grades: Easy(1)Difficult(2)Impossible(3)

5

Description
Cough
Timepoint
One minute after induction of anesthesia
Method of measurement
variable was measured qualitatively by 3 grades: Nil(1) ++(2) +++(3)

6

Description
Laryngospasm
Timepoint
One minute after induction of anesthesia
Method of measurement
variable was measured qualitatively by 3 grades: Nil(1) Moderate(2) Vigorous(3)

7

Description
Gagging
Timepoint
One minute after induction of anesthesia
Method of measurement
variable was measured qualitatively by 3 grades: Nil(1) ++(2) +++(3)

Secondary outcomes

empty

Intervention groups

1

Description
General anesthesia was induced for all patients with 2.5 mg/kg of IV propofol in the first group and patients received 1 μg/kg remifentanil and LMA was used for airway management
Category
Treatment - Drugs

2

Description
General anesthesia was induced for all patients with 2.5 mg/kg of IV propofol in the second group and patients received 1 μg/kg remifentanil and SLIPA was used for airway management
Category
Treatment - Drugs

3

Description
General anesthesia was induced for all patients with 2.5 mg/kg of IV propofol in the third group and patients received 1.5 μg/kg remifentanil and LMA was used for airway management
Category
Treatment - Drugs

4

Description
General anesthesia was induced for all patients with 2.5 mg/kg of IV propofol in the fourth group and patients received 1.5 μg/kg remifentanil and SLIPA was used for airway management
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-Asr hospital
Full name of responsible person
Dr Hesamaldin Modir
Street address
Vali-Asr hospital, Pirouzi Ave
City
Arak

2

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Hesamaldin Modir
Street address
Amiralmomenin Hospital, Basij Square
City
Arak

3

Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr Hesamaldin Modir
Street address
Amirkabir Hospital, Parastar Square
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences,Vice chancellor for research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University Of Medical Science, Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences,Vice chancellor for research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamaldin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Science, Alamolhoda Ave
City
Arak
Postal code
Phone
+98 86 1313 9793
Fax
Email
dr.hemodir@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Dr Hesamaldin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Science, Alamohoda Ave
City
Arak
Postal code
Phone
+98 86 1313 9793
Fax
Email
dr.hemodir@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamaldin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Science, Alamolhoda Ave
City
Arak
Postal code
Phone
Fax
Email
Web page address

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
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