Succinylcholine is a popular muscle relaxant for ambulatory anesthesia. Muscle fasciculation and post operative pain are common side effects of succinylcholine administration. The purpose of this double blind randomized controlled trial is to evaluate the efficacy of remifentanil in preventing succinylcholine-induced fasciculation and post operative pain in the patients undergoing general anesthesia. Based on inclusion and exclusion criteria 60 patients are included in the study and randomized using computer-generated random numbers into two groups of 30 patients according to pretreatment: NaCl 0.9% (control), and remifentanil 1µg/kg (study) that will be always adjusted to a 3-mL volume. The observer and the patients are unaware of the pretreatment used. The induction regimen is similar for all patients as follow: At time 0, injection of fentanyl 1 µg/kg and the pretreatment regimen according to the patient’s group; 2 min later, anesthesia will be induced with propofol 2 mg/kg IV and muscle relaxation will be achieved with succinylcholine 1.5 mg/kg. Following succinylcholine, duration (second) and severity of fasciculation according to a 4-point rating scale will be measured and recorded, and then post operative pain will be measured and recorded in one, 6 and 24 hour after operation according to 4-point rating scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712241766N1
Registration date:2009-09-11, 1388/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-09-11, 1388/06/20
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 siences
Expected recruitment start date
2008-12-22, 1387/10/02
Expected recruitment end date
2009-12-23, 1388/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of pretreatment effects of remifentanil on succinylcholine-induced fasciculation and post operative pain
Public title
Study of the effects of adding remifentanil to anesthetic drugs before succinylcholine on post operative myalgia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: American Society of Anesthesiologists (ASA) physical status I or II, ambulatory urological or gynecological surgery under general anesthesia. Exclusion criteria : arrhythmia, hypo- or hypertension, hyperkalemia, increased intraocular pressure, increased intracranial pressure, presenting a difficult airway, pregnant, treatment with any drug known to interact with neuromuscular function, and significant renal, neuromuscular, or hepatic disease.
Age
From 15 years old to 70 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 Siensces
Observational by 4-point scale: no fasciculation= 0; mild, fine fasciculation of the eyes, neck, face or fingers without limb movement = 1; moderate fasciculation occurring at more than two sites or obvious limb movement = 2; vigorous or severe, sustained, and widespread fasciculation = 3.
2
Description
Post operative pain
Timepoint
1 ,6 and 24 hours after operation
Method of measurement
4-point scale: nil = no muscle pains or stiffness; mild = muscle pains or stiffness at one site but not causing disability or limiting activities; moderate = muscle pains or stiffness at more than one site but not causing disability or limiting activities; severe = muscle pains or stiffness at one site or more and causing disability or limiting activities, e.g., difficulty getting out of bed or turning the head
Secondary outcomes
1
Description
Blood pressure changes
Timepoint
before induction of anesthesia and after ending fasciculation
Method of measurement
automated oscilometer
2
Description
Heart rate changes
Timepoint
Before induction of anesthesia and after ending fasciculation
Method of measurement
BSI (passport2) automated monitor
Intervention groups
1
Description
Remifentanil: in remifentanil group induction regimen is as follow: At time 0, injection of fentanyl 1 µg/kg and pretreatment (remifentanil 1µg/kg that be adjusted to a 3-mL volume) 2 min later, then propofol 2 mg/kg and after loss of eyelid reflexes succinylcholine 1.5 mg/kg
Category
Treatment - Drugs
2
Description
0.9 saline normal: In saline group induction regimen is as follow: At time 0, injection of fentanyl 1 µg/kg and pretreatment ( 3 ML 0.9 saline normal) 2 min later, then propofol 2 mg/kg and after loss of eyelid reflexes succinylcholine 1.5 mg/kg
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat hospital
Full name of responsible person
Karim Nasseri
Street address
Kshavarze St
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan university of medical siences
Full name of responsible person
Dr.Haidari
Street address
Pasdaran Blv.
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 siences
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
Faculty of medicine
Full name of responsible person
Mehdi Tayebi Arasteh
Position
Anesthsiologist/Assesstant professor
Other areas of specialty/work
Street address
Pasdaran Blv.
City
Sanandaj
Postal code
Phone
+98 87 1666 6463
Fax
Email
mehtayeb@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of medicine
Full name of responsible person
Karim Nasseri
Position
Anesthesiologist/assesstant professor
Other areas of specialty/work
Street address
Pasdaran Blv.
City
Sanandaj
Postal code
Phone
+98 87 1666 3728
Fax
Email
nasseri_k@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of nursing
Full name of responsible person
Shoaleh Shami
Position
Master of nursing
Other areas of specialty/work
Street address
Pasdaran Blv.
City
Sanandaj
Postal code
Phone
Fax
Email
shami471@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)