Protocol summary

Summary
This study was aimed to analyze the effect of three drugs (Propofol, Etomidate and Thiopental sodium) in hemodynamic changes during suspension laryngoscopy as hypnotic drugs. This is a double-blinded study on 75 patients undergoing elective suspension laryngoscopy. Inclusion criteria are: ASA (American Society of Anesthesiologists) I and II classes; 17 - 80 years old patients undergoing elective suspension laryngoscopy without history of hypertension; no history of cerebrovascular accidents; no history of acute porphyria; no food allergy (specially to soya and egg). Exclusion criteria are: airway obstruction; laryngospasm; need to re-intubation after laryngoscope excitation; systolic blood pressure less than 90 mmHg at fifth minute and surgery duration more than 30 minutes. Patients were divided into three groups of Etomidate (received 0.3 mg/kg), Propofol (received 2.2 mg/kg) and Thiopental sodium (received 5 mg/kg) and hemodynamic parameters at 1, 3, 5, 10, 15 minutes after induction and 3, 5, 15, 30 minutes after recovery, surgeon's satisfaction of surgery, surgery duration and recovery time were measured. We understood that there is no difference between administration of Propofol, Etomidate and Thiopental sodium in terms of hemodynamic changes, surgeon's satisfaction of anesthesia and surgery duration.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015030421327N1
Registration date: 2015-04-25, 1394/02/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Leila Karshenas
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
m-manoochehri@pel.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-03-16, 1392/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of induction of anesthesia by Propofol or Thiopental sodium or Etomidate on hemodynamic changes during microlaryngeal surgery
Public title
Comparison of the induction of anesthesia by Propofol or Thiopental sodium or Etomidate during microlaryngeal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 17-80; American Society of Anesthesiologist (ASA) I and II classes; no history of hypertension; no history of cerebrovascular accidents; no food allergy (especially to soya and egg); no history of acute porphyria Exclusion criteria: air way obstruction; laryngospasm; need to re-intubation after laryngoscope excitation; systolic blood pressure five minutes after induction of anesthesia less than 90 mmHg; surgery duration more than 30 minutes
Age
From 17 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jarib St.
City
Isfahan
Postal code
Approval date
2013-01-09, 1391/10/20
Ethics committee reference number
391459

Health conditions studied

1

Description of health condition studied
General anesthasia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Diastolic blood pressure
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
mm-Hg, sphygmomanometer

2

Description
Systolic blood pressure
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
mm-Hg, sphygmomanometer

3

Description
Heart rate
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
Electrocardiogram monitor

4

Description
O2 saturation
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
Pulseoxymeter

5

Description
Surgeon's satisfaction of surgery
Timepoint
After the surgery
Method of measurement
Questionnaire

6

Description
Time of surgery
Timepoint
Operation's time duration
Method of measurement
Timer

7

Description
Time of recovery hospitalization
Timepoint
Recovery duration
Method of measurement
Timer

8

Description
Mean arterial pressure
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
mm-Hg, sphygmomanometer

Secondary outcomes

1

Description
Hypotension
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
mm-Hg, sphygmomanometer

2

Description
Tachycardia
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
Electrocardiogram monitor

3

Description
Hypertension
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
mm-Hg, sphygmomanometer

4

Description
Bradycardia
Timepoint
Before and during intervention and after recovery time. 1, 3, 5, 10, 15 min after drug injection and 3, 5, 15, 30 min after recovery
Method of measurement
Electrocardiogram monitor

Intervention groups

1

Description
Propofol, 2.2 mg/kg within 30 seconds; IV.
Category
Treatment - Drugs

2

Description
Thiopental sodium, 5 mg/kg within 30 seconds; IV.
Category
Treatment - Drugs

3

Description
Etomidate, 0.3 mg/kg within 30 seconds; IV.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr Mehrdad Masoudifar
Street address
Alzahra Hospital, Soffe Blv, Isfahan, Iran
City
Isfahan

2

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Dr Mehrdad Masoudifar
Street address
Ayatollah Kashani Hospital, Ayatollah Kashani St.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehrdad Masoudifar
Street address
Isfahan University of Medical Sciences, Hezar jarib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Scineces
Full name of responsible person
Dr Mehrdad Masoudifar
Position
Assistant professor
Other areas of specialty/work
Street address
Alzahra medical center, Soffeh Blv.
City
Isfahan
Postal code
Phone
+98 31 3625 5555
Fax
Email
masoudifar@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehrdad Masoudifar
Position
Assistant professor
Other areas of specialty/work
Street address
Alzahra medical center, Soffeh Blv.
City
Isfahan
Postal code
Phone
+98 31 3625 5555
Fax
Email
masoudifar@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Leila Karshenas
Position
Medical student
Other areas of specialty/work
Street address
Alzahra medical center, Soffeh Blv.
City
Isfahan
Postal code
Phone
Fax
Email
krs.leila@gmail.com
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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