The aim of this randomized double-blind clinical trial is to evaluate effect of low dose Propofol on fentanyl-induced cough during induction of anesthesia. A total of 240 patients, meeting eligibility criteria, will be randomly allocated into two equal groups. After establishing routine monitors, vital sign profiles (blood pressure, heart rate and Spo2) are measured and serve as baseline values. Patients in group A received Propofol (10mg) and patients in group B received the same volume of normal saline (control group). All syringes containing Propofol or placebo were covered with masking tape to conceal any details of product or volume. Two minutes later, all patients were given fentanyl (2µg/kg) over 2 seconds via the peripheral IV line in the forearm. The vital sign profiles and frequency and intensity of cough will be recorded within two minutes after fentanyl bolus by a nurses blinded to study design. The intensity of cough was arbitrarily graded as the following: no cough (None), 1-2 cough (Mild), 3-4 cough (Moderate) and 5 cough or more (Severe).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305216803N4
Registration date:2013-08-04, 1392/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Abolfazl Firouzian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 6655
Email address
a.firouzian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low dose Propofol on fentanyl-induced cough during induction of anesthesia.
Public title
Effect of Propofol on fentanyl-induced cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed written consent; ASA class Ι-ΙΙ; Age between 18 - 50 years; Various elective surgical procedures under general anesthesia.
Exclusion criteria: History of asthma, chronic cough, lung disease; Smoking or substance abuse; Cardiac disease; Any disease or surgery of trachea or larynx; Upper respiratory tract infection in the previous four weeks; Impaired kidney or liver functions; Pregnancy and lactation; Medication with angiotensin-converting enzyme inhibitors (ACE), steroids, bronchodilators, antihistamine or antitussive drugs in the previous four weeks.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Postal code
4817844718
Approval date
2012-10-17, 1391/07/26
Ethics committee reference number
91-135
Health conditions studied
1
Description of health condition studied
fentanyl-induced cough
ICD-10 code
Y45.0
ICD-10 code description
Complications of medical and surgical care,Opioids and related analgesics
Primary outcomes
1
Description
Cough
Timepoint
Within two minutes after fentanyl injection
Method of measurement
Record in Questionnaire
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
First and two minutes after fentanyl injection
Method of measurement
Noninvasive arterial blood pressure
2
Description
Diastolic blood pressure
Timepoint
First and two minutes after fentanyl injection
Method of measurement
Noninvasive arterial blood pressure
3
Description
Mean arterial blood pressure
Timepoint
First and two minutes after fentanyl injection
Method of measurement
Noninvasive arterial blood pressure
4
Description
Heart rate
Timepoint
First and two minutes after fentanyl injection
Method of measurement
electrocardiogram
5
Description
Oxygen saturation
Timepoint
First and two minutes after fentanyl injection
Method of measurement
Pulse oxymeter
Intervention groups
1
Description
10 mg Propofol and two minutes later, 2µg/kg fentanyl
Category
Treatment - Drugs
2
Description
1 ml normal saline and two minutes later, 2µg/kg fentanyl
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Abolfazl Firouzian MD, Assistant Professor
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Grant name
10506
Grant code / Reference number
91-135
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1227 5038
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1227 5038
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)