Protocol summary

Summary
The purpose of this study is selection of the best drug among three available drugs: ephedrine, lidocaine and ketamine with a low dose to reduce injection pain and hypotension and bradycardia due to propofol injection. This randomized double-blinded placebo-controlled clinical trial study perform on 140 patients 20-40 years in ASA class I, who are candidate for elective surgery and anesthesia induction with propofol and the first experience of anesthesia. Patients randomly allocate to receive ephedrine 0.1mg/kg (Group E, n = 35) or lidocaine2% (group L, n=35) or ketamine0.1mg/kg (group K, n=35) or normal saline (group N, n=35) in volumes of 2cc, intravenously 30 second before propofol injection. During slow injection of propofol, pain and its severity is assessed with 4 points scale (0=no pain , 1=mild pain with frown, 2=moderate pain with frown and whine , 3=sever pain with withdrawal movement of hand and squeal ).Then 1.5- 2 cc fentanyl and 0.5 mg/kg atracurium is injected and after 3 min ventilation, trachea is intubated.systolic, diastolic and mean blood pressure and heart rate are measured and recorded before induction, just before intubation and after tracheal intubation.finally we analyze the collected data with using statistical software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102055764N1
Registration date: 2011-04-12, 1390/01/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-12, 1390/01/23
Registrant information
Name
Vida Ayatollahi
Name of organization / entity
Shahid Sadughi University
Country
Iran (Islamic Republic of)
Phone
+98 35 1821 5730
Email address
ayatt.vida@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of effects of ephedrine,lidocaine and ketamine with placebo on injection pain and hypotention & bradycardia due to propofol injection in patient under general anesthesia
Public title
Which drug is better for reducing injection pain and hypotention & bradycardia due to propofol injection
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: ; All of patients in ASA class I, who are candidated for elective surgery and anesthesia with propofol and this anesthesia is the first experience for them; exclusion criteria: ;Any patients that has unpredictable complications during information recording to (such asbronchospasms , ....) pain at the Injection site before or during the study drugs injection (before injection of propofol) Previous sensitivity to study drugs anxiety and lack of cooperation;
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 140
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 Medical Sciences and Health Services Shaid Sadoughi university
Street address
Central Organization of Medical Sciences and Health Services Shahid Sadoughi, Dr Bahonar Square
City
Yazd
Postal code
8916978477
Approval date
2009-06-07, 1388/03/17
Ethics committee reference number
پ/17/1/22456

Health conditions studied

1

Description of health condition studied
propofol injection pain
ICD-10 code
y48.2
ICD-10 code description
Drugs, medicaments and biological substances causing adverse effects in therapeutic use

Primary outcomes

1

Description
blood pressure
Timepoint
before starting. after injection and before tracheal int. after tracheal int
Method of measurement
mmHg by noninvasive automatic device

2

Description
propofol injection pain
Timepoint
during injection
Method of measurement
4 point visual

Secondary outcomes

1

Description
heart rate
Timepoint
before starting. after injection and before tracheal int. after tracheal int
Method of measurement
bit/min by EKG and pulsoximetry

Intervention groups

1

Description
efedrine- 0.1mg/kg- 2cc- iv-before propofol injection
Category
Prevention

2

Description
lidocaine 2%- 2cc- iv- before propofol injection
Category
Prevention

3

Description
ketamine- 0.1mg/kg- 2cc- iv- before propofol injection
Category
Prevention

4

Description
normal saline- placebo- 2cc- iv- before propofol injection
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Vida Ayatollahi, Anesthesiologist, Assistant professor
Street address
Ebnesina Str, Shahid Ghandi Aven, Shahid Sadughi Hospital
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, .... University of shahid sadoughi medical university
Full name of responsible person
Dr Hassan Mozaffari
Street address
Medical University, Bahonar Square
City
Yazd
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, .... University of shahid sadoughi medical university
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
Shahid Sadoughi Medical University
Full name of responsible person
Dr Vida Ayatollahi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Safaiye, Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
ayatt.vida@ssu.ac.ir; ayati.vida@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University
Full name of responsible person
Dr Vida Ayatollahi
Position
Anesthesiologist, Member of group, Assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1821 5730
Fax
Email
ayatt.vida@ssu.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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