The aim of this study was to evaluate the effect of thiopental sodium-midazolam combination on hemodynamic responses to tracheal intubation or laryngeal airway mask insertion.
Design
Single blind randomized clinical trial, the total sample size is 70
Settings and conduct
After confirmation by the Ethics Committee of Isfahan University of Medical Sciences, this randomized, single blind randomized clinical trial study was performed on 70 ASA-1,2 patients in the age group of 35 to 75 years who are candidates for short-term surgical procedures under general anesthesia. Patients are devided in two groups of 35 by using Random Allocation software in 2 groups airway administrations with ETT and LMA. Finally, the effect of thiopental sodium and midazolam on hemodynamic variables in two groups will be investigated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients undergoing elective short-term surgery (less than two hours)
Age of 35 to 75 years
ASA I-II
Exclusion criteria:
Obese patients
Pregnant women
Diabetic patients
COPD patients
Cardiovascular patients
predict difficult airway protection
Any allergies to used anesthetic drugs
Intervention groups
Group 1: Airway Administration with ETT. Group 2: Airway Administration with LMA
The effect of thiopental sodium-midazolam combination on hemodynamic response to tracheal intubation and laryngeal mask insertion
Public title
Effect of Thiopental Sodium - Midazolam on the hemodynamic response to the tracheal intubation and laryngeal mask insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing elective short-term surgery less than two hours
Age of 35 to 75 years and ASA I-II
Informed consent to Participate in the Study
Exclusion criteria:
Obese patients
Pregnant women
Diabetic patients
COPD patients
Cardiovascular patients
predict difficult airway management
History of allergy to used anesthetic drugs
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the criteria for entering the study randomly using random numbers generated by the computer assign to group E (Tracheal intubation) and group L ( laryngeal mask-insertion), the Patient allocation was performed by an independent researcher, who was unaware of the study groups,
Sequence numbers in the sealed black envelope were kept in an inaccessible location, at the end of the study, these numbers list were available for data analysis
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patient will not be aware of the airway management and the information will be obtained single blind.
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
2018-12-29, 1397/10/08
Ethics committee reference number
IR.MUI.MED.REC.1397.182
Health conditions studied
1
Description of health condition studied
Hemodynamic response
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
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
Pressure gauge
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
Pressure gauge
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, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Thiopental sodium 2.5 mg / kg, Midazolam 0.1 mg/kg and Atracurium 0.5 mg / kg, and the 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
First intervention group: After receiving 5 ml / kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Thiopental sodium 2.5 mg / kg, Midazolam 0.1 mg/kg and Atracurium 0.5 mg / kg, and the patients underwent mechanical ventilation by mask for three minutes. Then the airway is protected by LMA 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
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
Feiz Hospital, Modarres St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۶۴
Phone
+98 31 3668 8138
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
Feiz Hospital, Modarres St
City
Isfahan
Province
Isfehan
Postal code
8176473461
Phone
+98 31 3445 2034
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
Feiz Hospital, Modarres St
City
Isfahan
Province
Isfehan
Postal code
81764734610
Phone
+98 31 3620 2020
Fax
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