Protocol summary
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Study aim
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To assess the prophylactic effect of intravenous injection of Ondansetron versus placebo on shivering after spinal anesthesia in cesarean section
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Design
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This is a double-blind randomized clinical trial, phase II, in which 72 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients with indication of cesarean section referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 18 to 35 years,
Candidate for elective cesarean,
Exclusion criteria:
Sensitivity to Ondansetron,
Heart disease,
Liver or kidney disease,
Body temperature above 38-degree centigrade,
Body temperature below 36.5-degree centigrade,
Need to transfusion,
Length of surgery more than 180 minutes
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Intervention groups
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Intervention group:
Intravenous Ondansetron (manufactured by Tehran Chemistry Pharmaceutical Co.) 2 ml (4 mg) single dose 0.5 hour before surgery
Control group:
Intravenous normal saline (manufactured by Tehran Chemistry Pharmaceutical Co.) 2 ml single dose 0.5 hour before surgery
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Main outcome variables
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Primary outcome:
Observation of shivering,
Secondary outcome:
Nausea and vomiting
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N362
Registration date:
2020-07-27, 1399/05/06
Registration timing:
registered_while_recruiting
Last update:
2020-07-29, 1399/05/08
Update count:
1
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Registration date
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2020-07-27, 1399/05/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-20, 1399/01/01
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Expected recruitment end date
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2021-09-22, 1400/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Prophylactic effect of intravenous injection of Ondansetron versus placebo on shivering after spinal anesthesia in cesarean section: a double-blind randomized clinical trial
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Public title
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Prophylactic effect of intravenous injection of Ondansetron versus placebo on shivering after spinal anesthesia in cesarean section
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 to 35 years,
Candidate for elective cesarean,
Exclusion criteria:
Sensitivity to Ondansetron,
Heart disease,
Liver or kidney disease,
Body temperature above 38 degree centigrade,
Body temperature below 36.5 degree centigrade,
Need to transfusion,
Length of surgery more than 180 minutes
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The drugs will be given in coded envelopes. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-08, 1398/11/19
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Ethics committee reference number
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IR.UMSHA.REC.1398.998
Health conditions studied
1
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Description of health condition studied
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Cesarean
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ICD-10 code
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Z38.01
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ICD-10 code description
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Single liveborn infant, delivered by cesarean
Primary outcomes
1
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Description
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Observation of shivering
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Timepoint
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During surgery every 15 minutes and after surgery in the recovery unit every half an hour
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Method of measurement
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Using a standard checklist called Bedside Four Point Scale
Secondary outcomes
1
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Description
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Nausea and vomiting
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Timepoint
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After surgery in recovery unit every half an hour
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Method of measurement
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By taking history and physical examination
Intervention groups
1
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Description
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Intervention group: Intravenous Ondansetron (manufactured by Tehran Chemistry Pharmaceutical Co.) 2 ml (4 mg) single dose 0.5 hour before surgery
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Category
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Treatment - Drugs
2
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Description
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Control group: Intravenous normal saline (manufactured by Mashhad Samen Pharmaceutical Co.) 2 ml single dose 0.5 hour before surgery
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available