This study will be done to determine the comparative effects of ketamine, Nesdonal and Magnesium sulfate in reducing pain at the onset of anesthesia caused by Propofol injection in patients undergoing elective surgery.
This single-blind (patient) clinical trial study will be conducted on a population of patients requiring non-emergency surgeries. The sample size for each group will be determined using 25 patients. Eligible patients based on Rand between software were randomly divided into three groups . An 18-gauge intravenous catheter will be inserted for all patients in the dorsum of the hand. Patients in three group will be received 0.5 ml/kg of ketamine, 30 mg/kg Magnesium sulfate and 0.5 ml/kg of Nesdonal respectively. Next, 2.5 mg/kg of Propofol 2% will be administered at a rate of 1 ml/s. Verbal Rating Scale (VRS) will be used to assess the severity of pain during injection
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060528283N1
Registration date:2016-07-19, 1395/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-19, 1395/04/29
Registrant information
Name
Hooshang Akbari
Name of organization / entity
Mazandaran univercity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 0518
Email address
h.akbari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2013-10-01, 1392/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of ketamine, Magnesium sulfate and Nesdonal on Propofol injection pain in patients undergoing elective surgery
Public title
Comparison of the effects of ketamine, magnesium sulfate and nesdonal on propofol injection pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria ; class I and II ASA
Exclusion criteria; patients with high intracranial pressure, unstable hemodynamics, severe mental disorders, history of allergy to drugs used, kidney, liver or heart dysfunction, addiction and use of Calcium or Magnesium blockers
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Research Deputy of Mazandaran University of Medical Sciences
Secondary trial Id
90-122
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Science
Street address
Moalem Street, Moalem Square, Sari , Iran
City
Sari
Postal code
4815696869
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
90-122
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
Y48.2
ICD-10 code description
Other and unspecified general anaesthetics
Primary outcomes
1
Description
Propofol injection pain
Timepoint
Once
Method of measurement
Verbal Rating Scale
Secondary outcomes
1
Description
Side effects
Timepoint
For 1 hours
Method of measurement
Surveillance the patients
Intervention groups
1
Description
An 18-gauge intravenous catheter will be inserted for all patients in the dorsum of the hand. One minute prior to Propofol injection, all patients will be received the study drug through a 5 ml syringe In group one, patients will be received 0.5 ml/kg of ketamine (Trittau, Germany; production series 11-207). Next, 2.5 mg/kg of Propofol 2% (Melsugen, Germany; production series- 34209) will be administered at a rate of i 1 ml/s. Verbal Rating Scale (VRS) will be used to assess the severity of pain during injection
Category
Treatment - Drugs
2
Description
An 18-gauge intravenous catheter will be inserted for all patients in the dorsum of the hand. One minute prior to Propofol injection, all patients will be received the study drug through a 5 ml syringe. Patients in group two, will be receive 30 mg/kg of Magnesium sulfate (Pasteur Institute-Iran; production series 1228054891). Next, 2.5 mg/kg of Propofol 2% (Melsugen, Germany; production series- 34209) will be administered at a rate of i 1 ml/s. Verbal Rating Scale (VRS) will be used to assess the severity of pain during injection
Category
Treatment - Drugs
3
Description
An 18-gauge intravenous catheter will be inserted for all patients in the dorsum of the hand. One minute prior to Propofol injection, all patients will be received the study drug through a 5 ml syringe. Patients in group three, will be received 0.5 ml/kg of Nesdonal (Trittau, Germany; production series -207) at a rate of 1 mg/s. Next, 2.5 mg/kg of Propofol 2% (Melsugen, Germany; production series- 34209) will be administered at a rate of i 1 ml/s. Verbal Rating Scale (VRS) will be used to assess the severity of pain during injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Boali Hospital
Full name of responsible person
Dr hooshangakbari
Street address
Sari Boali Hospital, Emam SQ,Sari, Iran Sari
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
Dr Ahmad Ali Enayeti
Street address
Moalem Street, Moalem Square, Sari, Iran
City
Sari
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 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
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Attieh Nikkhah
Position
MSC in critical care nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran.
City
Sari
Postal code
4815698689
Phone
+98 11 3326 8923
Fax
+98 11 3326 8936
Email
atinik1357@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hooshang Akbari
Position
Assistant professor
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences sari, iran
City
Sari
Postal code
4815696869
Phone
+98 11 3326 8923
Fax
+98 11 3326 8936
Email
hooshangakbari48@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Attieh Nikkhah
Position
MSC in critical care nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences,Vessal Street, Sari, Iran.
City
Sari
Postal code
4815686968
Phone
+98 11 3326 8923
Fax
+98 11 3326 8936
Email
atinik1357@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)