Comparison of preventive effects of intrathecal pethidine and morphine on post spinal anesthesia shivering in patients undergoing elective cesarean section
Preventive effects of intrathecal morphine versus intrathecal pethidine on shivering after spinal anesthesia in patients undergoing elective cesarean surgery, a randomized double-blind intervention study with a control group criteria: candidates for elective caesarean section. Fill the consent form to participate in the study Exclusion Criteria: contraindications to spinal anesthesia. states of emergency. target= prevent shivering size of sample = 90 time of intervention = 6 months
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091414656N1
Registration date:2013-10-15, 1392/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-15, 1392/07/23
Registrant information
Name
Erfan Khezripour
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1324 0787
Email address
erfan.khezripour@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of preventive effects of intrathecal pethidine and morphine on post spinal anesthesia shivering in patients undergoing elective cesarean section
Public title
Influence of drugs pethidine and morphine in prevention of shivering after anesthesia in women undergoing cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
The study population consisted of patients for elective cesarean section is referring to the operating room Besat Hospital in Sanandaj city.
Inclusion criteria: - candidate for elective caesarean section - fill the consent form to participate in the study - physical status class I or II according to the American Society of Anesthesia
Exclusion Criteria: - contraindications to spinal anesthesia - patients with valvular heart disease - pulmonary hypertension - diabetes - preeclampsia - eclampsia - Sepsis - Emergency situations - Lumbar Spine Disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Inclusion criteria for patients who have 60 patients in two groups of 30 each in a randomized block (Block 6 persons) are located. The 25% incidence of shivering in patients undergoing spinal anesthesia are, and taking into account the 80% of power. Alpha equal to 05/0 for a sample size of 28 patients per group was calculated to increase the accuracy of the results of 30 patients in each group (n = 60) was promoted.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
, Opposite the hotel Shadi, Pasdaran avenue -
City
Sanandaj
Postal code
66177-13446
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
MUK.REC.1392.13
Health conditions studied
1
Description of health condition studied
Shivering after spinal anesthesia
ICD-10 code
074.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery
Primary outcomes
1
Description
Intensity of shivering after spinal anesthesia
Timepoint
After the intervention, the patient was awake in the recovery room to the exit from the operating room
Method of measurement
Evaluation standards for patient access time of discharge from chill out and chill duration and intensity based segmentation is based on 4 minutes scores is madeZero: no chills. Grade: mild fasciculation in the face and neck. Grade: trembling visible muscle groups in more than one category. Grade III: the major muscular activity involving the entire body.
based on observation of Anesthesiologists in the operating room and recovery room based on the observation of Anesthesia Technician
Intervention groups
1
Description
First, all persons entering the operating room for elective caesarean section in a registration form are numbered. Then, based on the criteria of inclusion and exclusion criteria of inclusion and exclusion criteria and if give informed consent to participate in research, are filed in Form No. 2.If you have exclusion criteria, number one, because it will be mentioned in the same form.Randvmyzyshn and referred to by the same anesthetic technicians will perform their work and involvement in the assessment will not only prepare the drug.The participants will be divided into two groups of 30 patients by the statistical and methodological consultant to anesthesia technician.Essential drugs list based on a statistical consultant to the technicians, producers and labels on individual numbers are labeled. The drug is administered by an anesthesiologist.Group A and Group B pethidine to morphine 10 mg of 2/0 mg with 5/12 mg bupivacaine Hyprbar 5/0%, spinal needle is injected into the subarachnoid space,Site of needle insertion, number of attempts to find the subarachnoid space is recorded by an anesthesiologist then supine status of the patient has been injected fluid variables, spinal anesthetic is injected with the drug.Any complications during the surgery and recovery if it is administered. Measurements will be performed by an anesthesiologist.
Category
Prevention
2
Description
The control group consisted of 30 people who are either on the same criteria entry and exit in the intervention group had been selected.The difference between the control group and the drug pethidine and morphine as the prevention of spinal anesthesia shivering are not used just the patient undergo spinal anesthesia by bupivacaine then all variables were recorded in the forum like intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sanandaj- Besat hospital
Full name of responsible person
Erfan Khezripour
Street address
plaque75-lane ansar7-kurdistan street-sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Ataollah Heidari
Street address
research office-kurdistan medical university-sanandaj
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
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
Kurdistan University of Medical Sciences
Full name of responsible person
Erfan Khezripour
Position
Medical student
Other areas of specialty/work
Street address
plaque75- lane ansar7- kurdistan avenue- sanandaj
City
Sanandaj
Postal code
6616733463
Phone
+98 87 1324 0787
Fax
Email
erfan.khezripour@muk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Karim Naseri
Position
Aneastesiologist
Other areas of specialty/work
Street address
, Opposite the hotel Shadi, Pasdaran avenue -
City
Sanandaj
Postal code
6617713446
Phone
+98 87 1666 4646
Fax
Email
bihoshi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Erfan Khezripour
Position
Medical student
Other areas of specialty/work
Street address
, Opposite the hotel Shadi, Pasdaran avenue -
City
Sanandaj
Postal code
6616733463
Phone
+98 87 1324 0787
Fax
Email
erfan.khezripour@muk.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)