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Comparison between prophylactic low dose ketamine and ondansetron for prevention of shivering after spinal anesthesia for elective cesarean section

Protocol summary

Summary
This study is a prospective and randomized double-blind clinical trial. The aim of this study is Comparision between prophylactic low dose ketamine and ondansetron for prevention of shivering after spinal anesthesia for elective cesarean section. Total of sample size is 117 patient with ages: 18-40 years old. Inclusion criteria are patients candidate for elective cesarean section with pfannenstiel incision, under spinal anesthesia. The patients with With a history of cardiovascular disease, allergy to ketamine or ondansetron will be excluded. Patients are randomly divided into three groups with table of random numbers by computer. Assessor of study and patients do not know about type of drug and grouping people. This study is 2-3 trial phase. First group receives 0.25 mg/kg of ketamin diluted in 10 ml normal saline, intravenously after spinal anesthesia. Second group receives 4 mg of ondansetron diluted in 10 ml of normal saline, intravenously after spinal anesthesia. Third group receives 10 ml of normal saline, intravenously after spinal anesthesia. Patients basic information such as age and sex, BMI, systolic and diastolic blood pressure, heart rate, intensity of patients shivering, dizziness, allergic reactions, nausea, vomiting and hallucinations during surgery and after surgery will be recorded in all three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040627258N1
Registration date: 2016-05-14, 1395/02/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-14, 1395/02/25
Registrant information
Name
Nazli Arbabi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
arbabi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between prophylactic low dose ketamine and ondansetron for prevention of shivering after spinal anesthesia for elective cesarean section
Public title
The effect of ketamine and ondansetron for prevention of shivering after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patients candidate for elective cesarean section with pfannenstiel incision under spinal anesthesia; ASA (American society of anesthesiology) physical class one and two; Patient with ages: 18-40 years old. Exclusion Criteria: history of kidney problems; cardiovascular disease; liver disease; mental illness; seizures; glaucoma; receiving blood products during surgery; lack of patient satisfaction; allergy to ketamine and ondansetron.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 117
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 Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.AJUMS.REC.1394.498

Health conditions studied

1

Description of health condition studied
shivering during and after spinal anesthesia
ICD-10 code
R68.0
ICD-10 code description
Hypothermia, not associated with low environmental temperature

Primary outcomes

1

Description
Intensity of shivering patients
Timepoint
Every 10 minute to 1 hour after surgery
Method of measurement
Based on the score shivering (0-4)

2

Description
Systolic blood pressure and diastolic blood pressure
Timepoint
Before administration and every ten minutes to an hour after surgery
Method of measurement
By using the pressure gauge - in millimeters of mercury

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Prescription 0.25 mg/kg of ketamin diluted in 10 ml normal saline, intravenously after spinal anesthesia.
Category
Treatment - Drugs

2

Description
Intervention group 2: Prescription 4 mg of ondansetron diluted in 10 ml of normal saline, intravenously after spinal anesthesia.
Category
Treatment - Drugs

3

Description
Control group: Prescription 10 ml of normal saline, intravenously after spinal anesthesia.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khomeini Hospital
Full name of responsible person
Mohammad Reza Gusheh
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nazli Arbabi
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
nazli_arbabi@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ahmad Reza Mohtadi
Position
anesthesiologist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
-
Phone
+98 61 3222 2922
Fax
-
Email
mohtadi.ar@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
-
Phone
00
Fax
Email
s.nz1990@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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