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Comparison of muscular relaxation quality between the combination of remifentanil-atracurium and succinylcholine in rapid sequence induction intubation

Protocol summary

Summary
Objectives: Rapid sequence induction and intubation is a quick method which can survive the patient by rapid control of airways in life-threatening emergencies. Therefore, an ideal muscle relaxant is a medication which has a rapid onset of action and makes endotracheal intubation possible in the shortest time. In this research, pharmaceutical combination of remifentanil-atracurium and succinylcholine are compared in terms of muscle relaxation quality. Design: Block randomization, without placebo, trial phase 2, including 70 patients under elective herniorrhaphy or limb orthopedic surgeries. Setting and conduct: Fentanyl, 1 µg/kg, intravenously, for anesthesia induction. Nesdonal, 6 mg/kg, intravenously, for anesthesia induction. Participants including major eligibility criteria: 70 patients under elective herniorrhaphy or limb orthopedic surgeries. Intervention: Group 1: Succinylcholine, 1.5 mg/kg, intravenously, for muscle relaxation. Group 2: Atracurium, 0.5 mg/kg, intravenously, for muscle relaxation. Remifentanil, 1 µg/kg, intravenously. Main outcome measures: Muscle relaxation quality, ease of laryngoscopy, ease of endotracheal intubation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071914056N1
Registration date: 2015-07-19, 1394/04/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-19, 1394/04/28
Registrant information
Name
Hesameddin Modir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 9680
Email address
he_modir@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of muscular relaxation quality between the combination of remifentanil-atracurium and succinylcholine in rapid sequence induction intubation
Public title
Comparison of muscle relaxation of two medications in breathing intubation of patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 15-65 years old; Candidate for hernioraphy or elective limb orthopedic surgeriy; ASA class I and II; Body mass index of less than 26; Mallampati score 1 and 2. Exclusion criteria: Mallampati score of 3 or more; patients with neuromuscular diseases; Family history of malignant hyperthermia; Family history of pseudocholinesterase deficiency; Pregnancy; Sensitivity to study medications.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2011-09-05, 1390/06/14
Ethics committee reference number
112-90-3

Health conditions studied

1

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

Primary outcomes

1

Description
Relaxation of jaw muscles
Timepoint
50 seconds after the injection of last medication
Method of measurement
Cooper scoring system

2

Description
Ease of intubation
Timepoint
50 seconds after the injection of last medication
Method of measurement
Cooper scoring system

3

Description
Ease of laryngoscopy
Timepoint
50 seconds after the injection of last medication
Method of measurement
Cooper scoring system

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 2: Atracurium, 0.5 mg/kg, intravenously, for muscle relaxation, before anesthesia. Remifentanil, 1 µg/kg, intravenously, before anesthesia.
Category
Other

2

Description
Intervention group 1: Succinylcholine, 1.5 mg/kg, intravenously, for muscle relaxation, before anesthesia.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Hesameddin Modir
Street address
Vali-e-Asr hospital, Vali-e-Asr square, Arak.
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 Ali Asghar Yaghoobi
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran.
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
Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran.
City
Arak
Postal code
Phone
+98 86 3417 3506
Fax
Email
he_modir@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran.
City
Arak
Postal code
Phone
+98 86 3417 3506
Fax
Email
he_modir@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
Hesameddin Modir
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran.
City
Arak
Postal code
Phone
+98 86 3417 3506
Fax
Email
he_modir@arakmu.ac.ir
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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