Protocol summary

Summary
In this double-blind (Patient and nurse) clinical trial, 120 patients candidate for cesarean section will be randomly divided into two groups of intervention and control with table of random numbers and intrathecal and intravenous Dexamethasone are compared to reduce post operation complications after cesarean section. Spinal anesthesia will be provided in a sitting position with a spinal needle (25 Gauge) made by Dr.japanco company, China in the space between L3-L4 or L4-L5 with injection of 10 mg Marcaine 0.5% (10 mL in 2 cc) and 0.2 mg of intrathecal morphine made by Iran hormone Co. in both groups. The case group receives 8 mg intrathecal Dexamethasone injected in the same space (2 cc, made by Iran Hormone Co.) and the control group receives 8 mg lntravenous Dexamethasone made by Iran Hormone Co. in addition to 2 cc intratechal distilled water in the same vertebral space. The severity and incidence of nausea, vomiting, itching and pain will be recorded by an expert nurse or anesthesiology resident who are unaware of the study groups in recovery room and then at 1, 6, 12 and 24 hours after discharge from the recovery based on visual analog scale (VAS). If nausea and vomiting rate is higher than 4, 4 mg ondansetron made by Iran Hormone Co. will be prescribed and the injection will be recorded. Then, the patient’s satisfaction is asked based on VAS. Finally, BMI, age, education level, duration of surgery and anesthesia, history of nausea and vomiting after surgery and the amount of ondansetron used 24 hours after surgery will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112631095N1
Registration date: 2017-01-30, 1395/11/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-30, 1395/11/11
Registrant information
Name
Alieh Zamani Kiasari
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3335 5080
Email address
azamani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of intrathecal with intravenous Dexamethasone to reduce post operation complications after cesarean section due to intrathecal Morphine
Public title
Clinical trial of comparison of intrathecal with intravenous Dexamethasone to reduce post operation complications after cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria includes informed consent and undergoing elective cesarean section. Exclusion criteria includes unwillingness of the patient to continue participating in the study, height less than 150 cm, mental Disorders, corticosteroid use, alcohol consumption and drug abuse, contraindication to receive regional anesthesia, allergy to drugs used in the study, diabetes, hypertension and receiving antiemetic medications 24 hours prior to surgery
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using simple randomization and table of random numbers, patients are randomly divided into two intervention and control groups. Also, this study is double-blind and the patient and the nurse or anesthesiology resident who complete the checklist are unaware of the study groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research of Mazandaran University of Medical Science, Moalem square, Moalem street, Sari, Iran
City
Sari
Postal code
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.MAZUMS.REC.94-1753 A

Health conditions studied

1

Description of health condition studied
Single delivery by caesarean section
ICD-10 code
O82
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
Nausea and vomiting
Timepoint
Recovery and then at 1, 6, 12 and 24 hours after discharge from recovery
Method of measurement
VAS

2

Description
Itching
Timepoint
Recovery and then at 1, 6, 12 and 24 hours after discharge from recovery
Method of measurement
VAS

3

Description
Pain
Timepoint
Recovery and then at 1, 6, 12 and 24 hours after discharge from recovery
Method of measurement
VAS

Secondary outcomes

1

Description
Patient Satisfaction
Timepoint
After discharge from recovery
Method of measurement
Visual analog scale

Intervention groups

1

Description
The intervention group receives 0.2 mg of intrathecal Morphine plus 8 mg of intrathecal Dexamethasone made by Iran Hormone Co. injected in L3-L4 or L4-L5 space
Category
Treatment - Drugs

2

Description
The control group receives 0.2 mg of intrathecal Morphine in inter-vertebral space and 8 mg lntravenous Dexamethasone made by Iran Hormone Co. in addition to 2 cc intratechal distilled water in the same vertebral space
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Sari
Full name of responsible person
Alieh Zamani Kiasari
Street address
Imam Khomeini Hospital, Amir Mazandarani Boulevard, Sari
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
Research deputy of Mazandaran University of Medical Science, Moallem Square, Sari
City
Sari
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, Mazandaran 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
Mazandaran University of Medical Science
Full name of responsible person
Khadijeh Ghavibonyeh
Position
Anesthesiology Residents
Other areas of specialty/work
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 5080
Fax
Email
ghavibonyehk@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Alieh Zamani Kiasari
Position
Assistance professor of Anesthesiology and Intensive Care
Other areas of specialty/work
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 5080
Fax
Email
aliehzamani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Alieh Zamani Kiasari
Position
Assistant professor of Anesthesiology and Intensive Care
Other areas of specialty/work
Street address
Clinical Research Development Center, Imam Khomeini Hospital, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 5080
Fax
Email
aliehzamani@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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