The purpose of this study is to compare the effect of infusion of ketofol on sedation score and hemodynamic variables of women who undergoing cesarean section under spinal anesthesia.In this double blind randomized clinical trial study, 60 ASA class I,18-40 years old patients randomly receive ketofol 1/10(infusion of 15 ml in 1 hour) or placebo(normal saline) during surgery.Sedation level of the patients is evaluated by sedation score every 15 minutes during the surgery.Systolic, diastolic, mean arterial pressures and heart rate measure every 3 minutes after spinal anesthesia until the end of surgery.Finally sedation score and hemodynamic variables(systolic, diastolic and mean arterial pressure, heart rate) are compared betwween two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509282963N23
Registration date:2016-02-23, 1394/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-23, 1394/12/04
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2015-10-13, 1394/07/21
Expected recruitment end date
2015-12-12, 1394/09/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of infusion of ketofol on hypotension due to spinal anesthesia in cesarean section
Public title
The evaluation of the effect of administration of ketofol on hypotension due to regional anesthesia in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:18-35 years old women with term pregnancy ؛ American Society of Anesthesia (ASA) physical status I ؛ non- emergency repeated cesarean delivery ؛spinal anesthesia.
exclusion criteria: BMI>35 ; chronic hypertension; placenta previa; placenta acreta; gestational age <28 weeks; polyhydroamnious.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
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
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar Square
City
Yazd
Postal code
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394.132
Health conditions studied
1
Description of health condition studied
ketofol
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified
Primary outcomes
1
Description
Hemodynamic variables
Timepoint
every 3 min during the surgery
Method of measurement
monitoring
Secondary outcomes
1
Description
level of sedation
Timepoint
every 15 min during the surgery
Method of measurement
Ramsay score
Intervention groups
1
Description
infusion of ketofol 1/10(infusion of 15 ml in 1 hour)or during surgery in intervention group
Category
Treatment - Drugs
2
Description
infusion of normal saline( 15 ml/h) during surgery in placebo group