Evaluation the effects of combination of Propofol-Remifentanil on Succinylcholine induced post operative fasciculations, myalgia and biochemical changes in lower abdominal surgeries
The aim of this study is to evaluate the effect of remifentanil on succinylcholine-induced biochemical changes and postoperative myalgia. Among patients who are scheduled for elective minor surgeries of lower abdomen, and according to the inclusion criteria, 60 patients will be selected, and randomly divided into two groups. Except the study drugs, the dose and type of main anesthetics are the same for all patients and including: fentanyl 1mcg/kg, propofol 2mg/kg and succynilcholine 1.5mg/kg. Pre-treatment for study group is remifentanil 1mcg/kg and for control group is 3ml of saline normal. Mean arterial blood pressure and heart rate will be measured and recorded three times (before induction of anesthesia, after induction of anesthesia, and after intubation of patient). After injection of succynilcholine the intensity and duration of muscle fasciculation will be measured and recorded for both of groups. Three blood samples will be obtained from all patients in three different times (before induction of anesthesia, after intubation of patient and 24hour after operation). First sample for serum potassium level (K) and Creatine PhosphoKinase(CPK), second for serum potassium and the thirds for CPK. A third party who is not aware of patients grouping will evaluate post operative myalgia, using a four-point Scale, at 5 different times. Results will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810141766N3
Registration date:2010-04-05, 1389/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-04-05, 1389/01/16
Registrant information
Name
Karim Nasseri
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 3728
Email address
nasseri_k@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2009-10-21, 1388/07/29
Expected recruitment end date
2010-10-21, 1389/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of combination of Propofol-Remifentanil on Succinylcholine induced post operative fasciculations, myalgia and biochemical changes in lower abdominal surgeries
Public title
Evaluation the effect o f Remifentanil on Succinylcholine-indused biochemical changes during anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Scheduled for elective surgery of lower abdomen (such as inguinal hernia, hydrocele and ...), signing informed consent, ASA class of 1 or 2. Exclusion criteria: addiction (opioides, alcohol, or psychological drugs), history of allergic reaction to study drugs, cholinesterase deficiency, hypertension, neuromuscular disease, pregnancy, and using drugs that interact with neuromuscular function.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Kurdistan University of Medical Sciences, Research Department
Street address
Passdaran Street
City
Sanandaj
Postal code
Approval date
empty
Ethics committee reference number
8017پ14پ، بند 5
Health conditions studied
1
Description of health condition studied
Complication of muscle relaxant drugs (succinylcholine), not elsewhere classified
ICD-10 code
T78.8
ICD-10 code description
Other adverse effects, not elsewhere classified
Primary outcomes
1
Description
Serum potassium level changes
Timepoint
befor induction of anesthesia and 5 minutes after injection of succinylcholine
Method of measurement
Laboratory
2
Description
Serum creatine phosphokinase level (CPK) changes
Timepoint
before induction of anesthesia and 24 hours after that
Method of measurement
Laboratory
Secondary outcomes
1
Description
Blood pressure changes
Timepoint
Before induction of anesthesia, after induction of anesthesia and after tracheal intubation
Method of measurement
Clinically (automated pressure gauge)
2
Description
Heart rate changes
Timepoint
before induction of anesthesia, after induction of anesthesia and after tracheal intubation
Method of measurement
Clinically (by automated monitoring)
3
Description
Postoperative myalgia
Timepoint
In 5 times, 2, 6, 24, 48 and 72 hours after operation
Method of measurement
By a 4-point scale questionnaire
4
Description
Duration of fasciculation
Timepoint
after injection of succinylcholine
Method of measurement
Chronometer
Intervention groups
1
Description
Injection of Remifentanil 1mcg/kg two minutes before the induction of anesthesia
Category
Treatment - Drugs
2
Description
Injection of 3 ml saline normal 0.9% (placebo) two minutes before the induction of anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Babak Qotbi
Street address
Keshavarz Street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences, Research Department
Full name of responsible person
Ataaolah Haidari
Street address
Passdaran Street
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan University of Medical Sciences, Research Department
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
Nursing and Midwifery School, Kurdistan University of Medical Sciences
Full name of responsible person
Shoaleh Shami
Position
Master of Nursing
Other areas of specialty/work
Street address
Jam Jam Street
City
Sanandaj
Postal code
6617965883
Phone
+98 87 1666 0733
Fax
+98 87 1666 4644
Email
shami471@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical school, Kurdistan University of Medical Sciences
Full name of responsible person
Karim Nasseri
Position
Anesthetist/Assistant Professor
Other areas of specialty/work
Street address
Jam Jam Street
City
Sanandaj
Postal code
6617965883
Phone
+98 87 1666 3728
Fax
+98 87 1328 5890
Email
nasseri_k@muk.ac.ir
Web page address
www.muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Medical school,Kurdistan University of Medical Sciences
Full name of responsible person
Karim Nasseri
Position
Anesthetist/Assistant Professor
Other areas of specialty/work
Street address
Jam Jam Street
City
Sanandaj
Postal code
6617965883
Phone
+98 87 1666 3728
Fax
+98 87 1328 5890
Email
nasseri_k@muk.ac.ir
Web page address
www.muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)