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Comparison of Analgesia of Fentanyl with Ketamine during Injection of Propofol

Protocol summary

Summary
After obtaining written informed consent from eligible patients, and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, a double-blind prospective, randomized study will be done among patients with elective surgery. Inclusion criteria: - The patient's satisfaction – Age between 20 and 60 years old. Exclusion criteria: - History of substance abuse; hypnotics or narcotics throughout 24 hours before the surgery - History of drug abuse, or alcohol- dependency - Contraindication of Propofol or Ketamine - High Intracranial Pressure Patients will be randomly allocated into three groups according to table of random numbers. Groups "one", "two", and "three" will receive normal saline 0.9%, 0.1 mg/kg of intravenous (IV) ketamine, and 1 mcg/kg of Intravenous Fentanyl, respectively. After 45 seconds, 1.5 mg/kg of propofol will be injected (at speed of 1 ml/s) and every 5 seconds, paying attention to the patient's face, using the method of Verbal Rating Scale (VRS) grading 0 to 3 {0-No; 1-Slight pain or discomfort; 2-Moderate pain; 3-Severe pain (changing the face or hand pulling back)}. Then, the patient will be asked about the pain during injection. Subsequently, the rest of propofol infusion will be injected and after reduced level of consciousness, other steps of anesthesia will be done. Then grading of pain during recovery, 6 and 12 hours after injection will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012112811597N1
Registration date: 2013-02-24, 1391/12/06
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-02-24, 1391/12/06
Registrant information
Name
Nooshin Runassi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1453 6879
Email address
runassi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2013-04-19, 1392/01/30
Expected recruitment end date
2013-08-21, 1392/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Analgesia of Fentanyl with Ketamine during Injection of Propofol
Public title
Analgesia of Fentanyl and Ketamine during Propofol Injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: - The patient's satisfaction – Age between 20 and 60 years old. Exclusion criteria: - History of substance abuse; hypnotics or narcotics throughout 24 hours before the surgery - History of drug abuse, or alcohol- dependency - Contraindication of Propofol or Ketamine - High Intracranial Pressure
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients are assigned randomly to 3 groups using a computerized allocation schedule for the coded syringes containing the study drugs. After randomization, the coded syringes are prepared by an anesthesiologist not involve in the administration of the drug, patient care and data collection.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No.12, Chamber Sadaf, Golestan Blvd
City
Ahvaz
Postal code
6135733777
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
U91122

Health conditions studied

1

Description of health condition studied
Pain during injection
ICD-10 code
T80.9
ICD-10 code description
Unspecified complication during therapeutic injection, transport and injection

Primary outcomes

1

Description
Pain during propofol injection
Timepoint
Every 5 seconds after injection
Method of measurement
Verbal Rating Scale

Secondary outcomes

1

Description
Sedation
Timepoint
Every 5 seconds after injection
Method of measurement
Watching

Intervention groups

1

Description
Drug: Ketamine Dose: 0.1mg/kg IV Injection Number of using: Once Factory name: Rotexmedica Manufacturing Country's name: Germany Administration time: 45 seconds before Propofol administration
Category
Treatment - Drugs

2

Description
Drug: Fentanil Dose: 1mcg/kg IV Injection Number of using: Once Factory name: Chekad Manufacturing Country's name: Iran Administration time: 45 seconds before Propofol administration
Category
Treatment - Drugs

3

Description
Placebo: Normal Saline 0.9% Dose used: 2 ml IV Injection Number of using: Once Factory name: Samen Pharmacy CO. Manufacturing Country's name: Iran Administration time: 45 seconds before Propofol administration
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Educational Hospital
Full name of responsible person
Dr. Reza Akhundzadeh
Street address
No. 307, Kokab Street, Masters Alley, Golestan Blvd.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
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, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nushin Runassi
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Phone
+98 61 1432 5879
Fax
+98 61 1432 5879
Email
runassi.n@ajums.ac.irmostafafatahi777@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nushin Runassi
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Phone
+98 61 1432 5879
Fax
+98 61 1432 5879
Email
runassi.n@ajums.ac.irmostafafatahi777@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nushin Runassi
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Phone
+98 61 1432 5879
Fax
+98 61 1432 5879
Email
runassi.n@ajums.ac.irmostafafatahi777@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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