Protocol summary
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Study aim
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Comparison of the effect of prophylactic injections of ketamine and Ondansetrone on shivering after cesarean section under spinal anesthesia
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 121 patients. Randomization is done using Random Allocation software.
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Settings and conduct
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This is a randomized double-blind clinical trial in which the target population of pregnant women is candidates for cesarean section under spinal anesthesia at Beheshti Hospital in Isfahan. Patients are randomly assigned to three groups C, B, and A, and each group is randomly assigned to one of three intervention groups, and the patient's vital signs are monitored before, during, and after surgery. The intervention groups are coded, so the injecting person, the clinical caregiver, and the patient are unaware of the injected intervention and are blind.
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Participants/Inclusion and exclusion criteria
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Pregnant women in grades I and ASA II, candidates for cesarean section under spinal anesthesia, can be screened if they have no history of high blood pressure, mental illness, heart problems with EF <60%, or kidney problems with GFR <60.
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Intervention groups
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Intervention group A: 4 mg of Ondansetron,
Intervention Group B; 0.5 mg of ketamine per kilogram of body weight and C intervention group; Normal saline as a placebo is injected into the patient immediately after clamping of the umbilical cord.
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Main outcome variables
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Shivering
General information
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Reason for update
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Adress changing
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160307026950N20
Registration date:
2020-06-10, 1399/03/21
Registration timing:
prospective
Last update:
2022-07-30, 1401/05/08
Update count:
1
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Registration date
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2020-06-10, 1399/03/21
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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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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-09-22, 1399/07/01
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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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Comparison of the effectiveness of intravenous injection of Ketamine and Ondansetron in the prevention of the post-operative shivering in Cesarean Section under spinal anesthesia
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Public title
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Ketamine and Ondansetron in post operative shivering in Cesarean Section
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women are candidates for cesarean section
Candidates for Spinal anesthesia
ASA class I and II
The patient's consent to participate in the study
Exclusion criteria:
History of high blood pressure
History of mental illness
History of heart problems with EF <60%
History of kidney problems with GFR <60
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
121
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done in a simple way so that the names of patients enter the randomization software (https://random-allocation-software.software.informer.com/2.0/) if they have the necessary conditions and according to the time of entry. software Randomly assign numbers to each patient, and based on these numbers, patients enter one of the intervention or control groups so that their number reaches the required number in each group.
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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 and placebo are packaged in the same form with the same volume and coded, and are randomly distributed among patients so
the attending, the clinical caregiver, and the evaluator do not notice the type of medication.
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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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2017-06-18, 1396/03/28
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Ethics committee reference number
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IR.MUI.REC.1396.3.028
Health conditions studied
1
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Description of health condition studied
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Postoperative shivering
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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shivering
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Timepoint
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Every 15 minutes from the beginning of the operation until the end of recovery
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Method of measurement
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Using Mahajan and Grassi criteria
2
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Description
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Central temprature
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Timepoint
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Every 15 minutes from the beginning of the operation until the end of recovery
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Method of measurement
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Tympanic thermometer
3
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Description
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Peripheral Temprature
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Timepoint
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Every 15 minutes from the beginning of the operation until the end of recovery
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Method of measurement
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Skin thermometer
Secondary outcomes
1
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Description
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Systolic Blood Pressure
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Timepoint
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Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery
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Method of measurement
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Non invasive blood pressure measurement
2
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Description
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Diastolic Blood Pressure
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Timepoint
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Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery
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Method of measurement
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Non invasive blood pressure measurement
3
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Description
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Mean Arterial Blood Pressure
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Timepoint
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Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery
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Method of measurement
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Non invasive blood pressure measurement
4
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Description
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Heart Rate
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Timepoint
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From the beginning of the spinal anesthesia to the end of recovery
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Method of measurement
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Heart monitoring device
5
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Description
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Oxygen saturation
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Timepoint
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From the beginning of the spinal anesthesia to the end of recovery
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Method of measurement
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Pulse oximetry device
Intervention groups
1
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Description
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Intervention group A: Ondansetron is injected into the patient at a dose of 4 mg immediately after umbilical cord clamping.
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Category
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Treatment - Drugs
2
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Description
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Intervention Group A; Ketamine 0.5 mg per kilogram of body weight is injected into the patient immediately after clamping the umbilical cord.
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Category
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Treatment - Drugs
3
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Description
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Control group C: Normal saline as a placebo is injected into the patient immediately after the umbilical cord clamp.
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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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Esfahan 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