Protocol summary

Summary
In this prospective double blind clinical trial, 150 pregnant women aged 18-40 years old with ASA class 1&2 candidates for cesarean section under spinal anesthesia in Fatemie Hospital are randomly divided into three groups in 5 random block. Exclusion criteria: high risk pregnancy; multiple pregnancy; emergency cesarean section; pre-eclampsia & eclampsia; cardiovascular disease; respiratory disease; psychiatric disease; thyroid disease; diabetes melitus; long history of corticosteroids administration; hypertension; peptic ulcer; need to get blood products; temperature >38 c and contraindication of spinal anesthesia. After spinal anesthesia and neonate delivery patients received 3cc hydrocortisone (2 mg/kg, "A" group) or 3cc ketamine (0.5 mg/kg, "B" group) or 3cc normal saline (%0.9, "C" group) intravenously in 10-15 S duration after umbilical cord clamping. In all patients systolic and diastolic pressure, mean arterial pressure, heart rate, oxygen saturation level, body temperature and sedation score were recorded before anesthesia and then every minute for 5 minute, every 5 minutes for 15 minute, every 10 minutes until the end of surgery. Also, hallucination, nausea and vomiting, incidence and intensity of shivering and using amount of pethidine and ephedrine were recorded in questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016073110841N6
Registration date: 2016-09-14, 1395/06/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-14, 1395/06/24
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences, vice chanceller for research
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing intravenous hydrocortisone versus ketamine on reducing of post spinal shivering in cesarean section
Public title
Prevention of post spinal shivering by drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women aged 18 -40 years old; ASA class 1&2; term pregnant patients (gestational age 36-40 weeks) and candidate for cesarean section under spinal anesthesia . Exclusion criteria: high risk pregnancy; multiple pregnancy; emergency cesarean section; pre-eclampsia & eclampsia; cardiovascular disease; respiratory disease; psychiatric disease; thyroid disease; diabetes melitus; long history of corticosteroids administration; hypertension; peptic ulcer; need to get blood products; temperature >38 c and contraindication of spinal anesthesia.
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: 150
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
Hamadan university of Medical Sciences
Street address
Fahmide Street
City
Hamadan
Postal code
6517838678
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
IR.UMSHA.REC.1394.462

Health conditions studied

1

Description of health condition studied
post spinal shivering
ICD-10 code
O74.9
ICD-10 code description
Complication of anaesthesia during labour and delivery, unspecified

Primary outcomes

1

Description
systolic and diastolic blood presure
Timepoint
1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery
Method of measurement
mmHg and by noninvasive automatic blood pressure monitoring

2

Description
Mean arterial pressure
Timepoint
1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery
Method of measurement
mmHg and by noninvasive automatic blood pressure monitoring

3

Description
Heart Rate
Timepoint
1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery
Method of measurement
Beat per minute and by ECG monitoring

4

Description
SPO2
Timepoint
1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery
Method of measurement
Percent and by pulse oxymetry

5

Description
Tempreture
Timepoint
each 15 minutes until end of recovery
Method of measurement
degree and by medical oral termometer

6

Description
frequency of shivering
Timepoint
during sergury and in recovery
Method of measurement
Observation

7

Description
shiverig grading
Timepoint
during sergury and in recovery
Method of measurement
shivering score

8

Description
consumption of pethidine
Timepoint
during sergury and in recovery
Method of measurement
mg and by observation

9

Description
consumption ofephedrine
Timepoint
during sergury and in recovery
Method of measurement
mg and by observation

10

Description
Neonate APGAR
Timepoint
1&5 minutes after birth
Method of measurement
APGAR Score

Secondary outcomes

1

Description
sedation score
Timepoint
1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery
Method of measurement
Ramsay score

2

Description
Hallocination
Timepoint
during surgery & recovery
Method of measurement
observation & interview

3

Description
nausea & vomiting
Timepoint
during surgery
Method of measurement
observation & interview

4

Description
nistagmus
Timepoint
during surgery & recovery
Method of measurement
Observation & Examination

Intervention groups

1

Description
After spinal anesthesia, in group A 2mg/kg hydrocortison (3ml),after clamping of umblical cord intravenously is injected.
Category
Prevention

2

Description
After spinal anesthesia , in ketamine group ,0.5 mg/kg ketamine (3ml) after clamping of umblical cord intravenously is injected .
Category
Prevention

3

Description
After spinal anesthesia, in control group 3ml normal salin , after clamping of umblical cord intravenously is injected.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Pasdaran Street
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences, vice chancellor for research
Full name of responsible person
Dr. Saeed Bashirian
Street address
Fahmide Street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences, vice chancellor for research
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
Hamadan University of Medical Sciences, Fatemie Hospital
Full name of responsible person
Nahid Manouchehrian
Position
Associated professor of anesthesia Department, Special Board of Anesthesia
Other areas of specialty/work
Street address
Pasdaran Street
City
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com; manouchehrian@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences, Fatemie Hospital
Full name of responsible person
Nahid Manouchehrian
Position
Associated professor of Anesthesia Department-Special Board of Anesthesia
Other areas of specialty/work
Street address
Pasdaran Street
City
Hamadan
Postal code
65177-89971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com; manouchehrian@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences, Fatemie Hospital
Full name of responsible person
Nahid Manouchehrian
Position
Associated professor of Anesthesia Department-Special Board of Anesthesia
Other areas of specialty/work
Street address
Pasdaran Street
City
Hamadan
Postal code
65177-89971
Phone
+98 81 3827 7012
Fax
+98 81 3821 0171
Email
manuchehriann@gmail.com; manouchehrian@umsha.ac.ir
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
Loading...