Evaluation and comparison of cardiovascular response to laryngoscopy and endotracheal intubation in induction of anesthesia with etomidate and thiopental sodium - Midazolam
Determination and comparison of cardiovascular response to laryngoscopy and endotracheal intubation in induction of anesthesia with etomidate and thiopental sodium - Midazolam
Design
A randomized double-blind clinical trial. The total sample size was 78 persons.
Settings and conduct
Following the approval of the Ethics Committee of Isfahan University of Medical Sciences, this randomized double-blind clinical trial study is performed in Isfahan 1398-1399.feiz and Alzahra hospitals, on 78 ASA-1,2 patients aged 18-70 years, from both sexes, male and female, ,who are condidate for Short-term surgery under general anesthesia. After obtaining informed consent from eligible patients, patients are studied in two groups of 39 persons which protecting airway with ETT.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who are candidates for short-term elective surgery(less than2hours) under general anesthesia;
age between18 to70; ASA1&2.
Exclusion criteria: obess patients (BMI more than25); pregnant women; uncontrolled diabetic patients; uncontrolled COPD patients; uncontrolled cardiovascular patients; chronic analgesic or sedative use; any uncontrolled systemic disease; predicting the difficulty of airway protection; any allergies to the anesthetics used
Intervention groups
After receiving 5 ml/kg of ringer lactate and pre-oxygenation for patients, induction of anesthesia was performed including Fentanyl 2mcg/kg, Etomidate 0.3mg/kg (in group E), Thiopental sodium 2.5 mg/kg and Midazolam 0.075 mg/kg (in group TM), and Atracurium 0.5 m/kg (in both groups). Then patients underwent mechanical ventilation by mask for three minutes.Then the airway is protected by ETT and the patient is attached to the anesthetic machine and is mechanically ventilated.
Evaluation and comparison of cardiovascular response to laryngoscopy and endotracheal intubation in induction of anesthesia with etomidate and thiopental sodium - Midazolam
Public title
Comparison of cardiovascular response to laryngoscopy and endotracheal intubation in induction of anesthesia with etomidate and thiopental sodium - Midazolam
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for short-term elective surgery (less than2 hours) under general anesthesia
Age between 18 to 70 years old
ASA1&2
Exclusion criteria:
Obese patients
Pregnant women
Uncontrolled diabetic patients
Uncontrolled COPD patients
Uncontrolled cardiovascular patients
Chronic analgesic or sedative use
BMI more than 25 kg/m2
Any Uncontrolled systemic disease
Predicting the difficulty of airway protection
Any sensitivity or allergies to the anesthetics agent used
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation to intervention and control groups using Random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient and observer who collects the information will not be in the course of the study, as the drug is injected by the planter, but the data will be collected by another person who is not in the study and the information will be double-blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.MUI.MED.REC.1398.622
Health conditions studied
1
Description of health condition studied
Cardiovascular response
ICD-10 code
Other comp
ICD-10 code description
T88.5
Primary outcomes
1
Description
Heart rate
Timepoint
Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 and 10 after intubation
Method of measurement
Electrocardiogram (EKG)
2
Description
Blood pressure
Timepoint
Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 and 10 after intubation
Method of measurement
Barometer
3
Description
Mean arterial pressure
Timepoint
Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 and 10 after intubation
Method of measurement
Barometer
4
Description
Oxygen saturation percentage
Timepoint
Basic time, minutes 1 and 3 after induction and minutes 1, 3, 5 and 10 after intubation
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: after receiving 5 ml/kg of ringer lactate and pre-oxygenation for patients, induction of anesthesia was performed including Fentanyl 2mcg/kg, Etomidate 0.3mg/kg, Atracurium 0.5 m/kg.Then patients underwent mechanical ventilation by mask for three minutes.Then the airway is protected by ETT and the patient is attached to the anesthetic machine and is mechanically ventilated and maintained anesthetized with iso-fluorine 0.8-1.2 Mac, with oxygen and N2O of 50%
Category
Treatment - Drugs
2
Description
Second intervention group: after receiving 5 ml/kg of ringer lactate and pre-oxygenation for patients, induction of anesthesia was performed including Fentanyl 2mcg/kg, Thiopental sodium 2.5 mg/kg and Midazolam 0.075 mg/kg, Atracurium 0.5 m/kg.Then patients underwent mechanical ventilation by mask for three minutes.Then the airway is protected by ETT and the patient is attached to the anesthetic machine and is mechanically ventilated and maintained anesthetized with iso-fluorine 0.8-1.2 Mac, with oxygen and N2O of 50%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Feyz Hospital , Modares St
City
isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Al-Zahra Therapeutic Training Center, Sofeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1818
Email
hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Haghjoo javanmard
Street address
Hizar jarib BLVD, Isfahan University of Medical Sciences and Health Services - Deputy of Research and Technology of the University
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Therapeutic Training Center, Sofeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Therapeutic Training Center, Sofeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al-Zahra Therapeutic Training Center, Safeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
hamidshetabi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available