Protocol summary

Summary
Objectives: Among regional anesthesia techniques, spinal anesthesia is more practical due to ease of technique, more speed, reliable nerve block, using minimum dose of local anesthetics, and the cost-effectiveness. However, this method is also associated with complications, and hypotension induced by sympathetic block is the most common of them. Ondansetron, as a serotonin receptor antagonist can reduce hypotension-induced by spinal anesthesia. Next drug is ketamine which is used for analgesia during labor. Ketamine is a N-methyl-D-aspartate (NMDA) receptor antagonist and a common drug used to induce anesthesia in pregnant women. The aim of this study is to compare prophylactic effect of ondansetron and ketamine on spinal anesthesia induced hypotension in cesarean section. Design: Block randomization, triple blind, with placebo, trial phase 2, including 93 patients under elective cesarean section. Setting and conduct: Lidocaine 5%, 75 milligrams, injection into the subdural space to induce spinal anesthesia. Participants including major eligibility criteria: All women who are supposed to undergo elective cesarean section. Intervention: Ondansetron, 4 milligrams (2 ml), slow IV injection in 30 seconds. Ketamine, 25 milligrams (volume 2 ml with distilled water), IV injection. Normal saline, 2 ml, IV injection in control group. Main outcome measures: Systolic blood pressure, diastolic blood pressure, arterial O2 saturation, heart rate, Level of consciousness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102315137N1
Registration date: 2014-01-28, 1392/11/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-28, 1392/11/08
Registrant information
Name
Saeid Bagherbandi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
dr.bagherbandi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic effect of ondansetron and ketamine on spinal anesthesia-induced hypotension in cesarean section
Public title
Comparison of the effects of ondansetron and ketamine on spinal anesthesia-induced hypotension in women undergoing cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women candidate for elective cesarean with spinal anesthesia who referred to Taleghani hospital, Arak. Exclusion criteria: Dissatisfaction of patient; Hypertension; Cardiovascular diseases; Body mass index upper 35; History of liver disease; History of migraine and seizure; Allergy to ondansetron; History of taking any medications that affect blood pressure or heart rate; Failure of spinal anesthesia; In top spinal cord Injuries; Need to additional drugs
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Injecting person, and the person responsible for collecting data are not aware of injecting drug. Syringes containing drug are prepared by someone else and are only labeled by the letters A, B, and C.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Approval date
2013-07-15, 1392/04/24
Ethics committee reference number
14-149-92

Health conditions studied

1

Description of health condition studied
Hypotension
ICD-10 code
I95, I95.0
ICD-10 code description
Hypotension due to drugs

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Before spinal anesthesia and every five minutes to thirty minutes after taking drug
Method of measurement
Sphygmomanometer

2

Description
Diastolic blood pressure
Timepoint
Before spinal anesthesia and every five minutes to thirty minutes after taking drug
Method of measurement
Sphygmomanometer

3

Description
Arterial O2 saturation
Timepoint
Before spinal anesthesia and every five minutes to thirty minutes after taking drug
Method of measurement
Pulse oximeter

4

Description
Heart rate
Timepoint
Before spinal anesthesia and every five minutes to thirty minutes after taking drug
Method of measurement
Cardiac monitor

5

Description
Level of consciousness
Timepoint
Before spinal anesthesia and thirty minutes after taking drug
Method of measurement
Ramsay score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1. Ondansetron, 4 milligrams (2 ml), slow IV injection in 30 seconds; made in Tehran Chemistry Pharma Co. with chemical composition (RS)-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-2,3-dihydro-1H-carbazol-4(9H)-one
Category
Prevention

2

Description
Intervention 2. Ketamine, 25 milligrams (volume 2 ml with distilled water), IV injection; made in TRITTAU company, GERMANY, with chemical composition (RS)-2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone
Category
Prevention

3

Description
Intervention 3. Normal saline, 2 ml, IV injection in control group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Saeid Bagherbandi
Street address
Taleghani hospital. Imam Khomeini street. Arak. Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Saeid Bagherbandi
Position
Anesthesiology Assistant
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3505
Fax
Email
dr.bagherbandi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Saeid Bagherbandi
Position
General practitioner
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3505
Fax
Email
dr.bagherbandi@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Saeid Bagherbandi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Arak University of Medical Sciences. Basij Square. Sardasht. Arak. Iran
City
Arak
Postal code
Phone
+98 86 3417 3505
Fax
Email
dr.bagherbandi@arakmu.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
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