In this clinical trial we are aiming at comparing hemodynamic responses following laryngoscopy and intubation after induction of anesthesia with 0.4mg/kg Diazepam and 0.3mg/kg Etomidate. This is a double blind study on 180 patients undergoing elective orthopedic surgery with average length of 1.5 - 4 hours. Inclusion criteria are: American Association of Anesthesiologists’ (ASA) classification of I or II; age 25 -65 years. Exclusion criteria are: ASA classification of 3-6 (severe systemic disorders such as CRF and CHF); patients with fever, anemia, seasonal or food allergy or known medicine hypersensitivity; hypertension;, hypo tension; consumption of beta blockers; kidney and liver disorders; drug abuse; dehydration and anxious patients with heart rate of100 b/m or more. The patients after obtaining informed consent will be divided into two groups of 90 ones. The method of anesthesia in both is similar consisting of Fentanyl (2µg/kg) as an analgesic, Succinyl 2mg/kg for relaxation and intubation, and Isoflurane, N2O and O2 for maintenance of anesthesia. However in group 1 we employ 0.4 mg/kg Diazepam and in group 2 we administer 0.3 mg/kg Etomidate. The hemodynamic conditions of the patients will be recorded in four steps (at the time of entrance, just after intubation, 5 and 10 minutes after intubation). Awareness of patients will be determined at the end as well. Collected data will be analyzed by means of SPSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010512007N1
Registration date:2013-01-26, 1391/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-26, 1391/11/07
Registrant information
Name
Mohammad Reza Doroudian
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1246 2055
Email address
mdoroudian@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2012-09-01, 1391/06/11
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Diazepam and Etomidate on hemodynamic responses to laryngoscopy and intubation
Public title
Comparison of the effect of Diazepam and Etomidate on cardiovascular system after laryngoscopy and intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: American Association of Anesthesiologists’ (ASA) classification of I or II; age 25 -65 years. Exclusion criteria are: ASA classification of 3-6 (severe systemic disorders such as CRF and CHF); patients with fever, anemia, seasonal or food allergy or known medicine hypersensitivity; hypertension;, hypo tension; consumption of beta blockers; kidney and liver disorders; drug abuse; dehydration and anxious patients with heart rate of100 b/m or more.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients will be assessed in two identical groups of Diazepam and Etomidate. Randomization is made through minimization which neutralizes the issue of age. In fact these two groups have an identical range of age. The mechanism of collecting data is a checklist which is filled through inspection, examination and reviewing documents. The first part of it is about demographic information and the second part is for recording our observations which documents hemodynamic condition of the patient in four steps (after lying on surgical bed, immediately after intubation, 5 and 10 minutes later). We collect these data by means of digital monitoring device. At the end of anesthesia the awareness of patient will be assessed as well. We have to mention that the resident of anesthesia is not in participation of evaluating hemodynamic values and a technician will documents them without awareness of injected drug.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Ethics Committee
Street address
Jomhoori boulevard
City
Kerman
Postal code
Approval date
2011-12-11, 1390/09/20
Ethics committee reference number
k/90/306
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
blood pressure
Timepoint
after lying on surgical bed, immediately after intubation, 5 and 10 minutes later
Method of measurement
digital monitoring device
2
Description
heart rate
Timepoint
after lying on surgical bed, immediately after intubation, 5 and 10 minutes later
Method of measurement
digital monitoring device
Secondary outcomes
1
Description
awareness
Timepoint
at the end of anesthesia
Method of measurement
asking the patient
Intervention groups
1
Description
Intervention: Diazepam (each ampoule contains10mg/2ml , made by Kimidaroo/Iran) injecting IV with dosage of 0.4mg/kg before induction of anesthesia
Category
Treatment - Drugs
2
Description
Control group: Etomidate (each ampoule contains20mg/10ml , made by Janssen-Cling/Australia) injecting IV and stat with dosage of 0.3mg/kg before induction of anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital of Kerman
Full name of responsible person
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mahdi Khodadadzadeh
Position
MD, Resident of anesthesiology
Other areas of specialty/work
Street address
Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
javadkordi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammadreza Doroudian
Position
anesthesiologist
Other areas of specialty/work
Street address
Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
mdoroudian@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdi Khodadadzadeh
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
javadkordi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)