Protocol summary

Summary
Purpose: The aim of this study was the evaluation of hemodynamic effects of the drugs that are commonly used in anesthesia to evaluate which anesthetic causes fewer changes in smokers. Design and criteria: 64 smokers patients, with ASA I-II and 18-60 years of age who are undergoing general anesthesia were enrolled. Patients with a history of hypertension, coronary artery disease, seizure, psychiatric disease, liver or kidney disease, drug abuse, hypersensitivity to fentanyl, ketamine, propofol and atracurium are excluded. Methods: Before induction, all patients receive ringer 5 cc/kg. The monitoring of ECG, heart rate, pulse oximetry and noninvasive blood pressure measurement is performed. In first group we inject 1 mg midazolam, 0.5 mg/kg ketamine and 2 mg/kg propofol with rate of 80 mg/kg/h. In second group we administrate 2 microgr/kg fentanyl instead ketamine. After eye reflex loss, atracurium 0.5 mg / kg is injected. After 2-3 min the patients are intubated with endotracheal tube. Anesthesia is maintained with propofol 100 microgr/kg and O2-N2O 50%. Primary outcomes: Vital signs, including systolic blood pressure, diastolic blood pressure and heart rate before induction, before and after intubation and then every 5 minutes until half-an-hour are measured and recorded. Also laryngospasm and bronchospasm are evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201305099229N2
Registration date: 2013-05-25, 1392/03/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-25, 1392/03/04
Registrant information
Name
Mehryar Taghavi Gilani
Name of organization / entity
Medical University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
taghavim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad Universiy of Medical Sciences
Expected recruitment start date
2013-04-13, 1392/01/24
Expected recruitment end date
2013-09-15, 1392/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic changes of propofol -ketamine with propofol-fentanyl in induction of anesthesia in smokers
Public title
Comparison of hemodynamic changes following propofol
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: smokers; ASA I-II; 18-60 years old exclusion criteria: hypertension; coronary artery disease; epilepsy; psychological disease; hepaic and renal disease; addiction; sensitivity to fentanil; ketamin; propofol and atracurium; difficult intubation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
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 Mashhad University of Medical Science
Street address
Vice Chancellor for Research, Mashhad University of Medical Science, Ghoreishi apartment, Daneshgah street
City
Mashhad
Postal code
Approval date
2013-04-13, 1392/01/24
Ethics committee reference number
910962

Health conditions studied

1

Description of health condition studied
Hemodyanmic changes following drug
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs

Primary outcomes

1

Description
Blood pressure changes
Timepoint
Befor induction, befor and after intubation, every five minutes
Method of measurement
Perioperative monitoring

2

Description
Heart rate changes
Timepoint
Befor induction, befor and after intubation, every five minutes
Method of measurement
Perioperative monitoring

Secondary outcomes

1

Description
laryngospasm, salivary secretion increase
Timepoint
After intubation
Method of measurement
Clinical observation

Intervention groups

1

Description
first group: fentanil administration before propofol induction
Category
Prevention

2

Description
second group: ketamin administration before propofol induction
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency Operating Room, Imam Reza Hospital
Full name of responsible person
Mehryar Taghavi Gilani
Street address
Bahar street
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Mehryar Taghavi Gilani
Street address
Vice Chancellor for Research, Mashhad University of Medical Science, Ghoreishi apartment, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Science
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
Imam Reza Hospital
Full name of responsible person
Mehryar Taghavi Gilani
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesia Department, Imam Reza Hospital, Bahar street
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
Taghavim@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mehryar Taghavi Gilani
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesia Department, Imam Reza Hospital, Bahar street
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
Taghavim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Mehryar Taghavi Gilani
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesia Department, Imam Reza Hospital, Bahar street
City
Mashhad
Postal code
Phone
+98 51 1852 5209
Fax
Email
Taghavim@mums.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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