Postspinal Shivering
Conditions
Keywords
shivering after spinal anesthesia in cesarean section
Brief summary
The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia.
Detailed description
Study groups: Randomization will be done according to computer guided table with sealed closed envelopes prepared by the supervisor, All study drugs will be prepared by the supervisor. Each group will be 25 patients.
Interventions
DRUGDexmedetomidine
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DRUGGranisetron
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OTHERPlacebo
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Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Group C: Patients in this group will receive 10 ml normal saline (0.9%) over 10minutes immediately after clamping of the cord (control group). Group D: Patients in this group will receive (0.3 ug/kg) intravenous Dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord. Group G: Patients in this group will receive 3 mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* patients scheduled for cesarean section under spinal anesthesia. * age : (20-45) years old. * American Society of Anesthesia (ASA) physical status I, II.
Exclusion criteria
* Patient refusal. * Contraindication to spinal anesthesia. * BMI \> 35 kg/m². * Impaired renal, hepatic and cardiac function. * Thyroid disease. * Body temperature \>38 °C or \< 36.5 °C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of post spinal shivering. | every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours | -The Shivering will be graded on a scale Tsai and Chu \[Tsai et al .,2001\] : Grade 0= No shivering. Grade 1=Piloerection or peripheral vasoconstriction but no visible shivering. Grade 2=Muscular activity in only one muscle group. Grade 3=Muscular activity in more than one muscle group but not generalized. Grade 4=Shivering involving the whole body. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in the basal axillary temperature. | preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively | Changes in basal axillary temperature (Celsius (°C) scale) of the patient after administration of tested drugs. |
| change in the basal mean arterial blood pressure | preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively. | Changes in the basal non-invasive mean arterial blood pressure( millimetres mercury (mmHg)) of the patient after administration of tested drugs. |
| Change in the basal heart rate | preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively. | Change in the heart rate of the patient after administration of tested drugs (beat per minute) |
Countries
Egypt
Outcome results
None listed