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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine Group | Active Comparator | 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. |
|
| Granisetron Group | Active Comparator | Patients in this group will receive 3mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord. |
|
| Control Group | Placebo Comparator | Patients in this group will receive 10 ml normal saline 0.9% over 10 minutes immediately after clamping of the cord (placebo control group). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | label sticker |
| |
| Granisetron |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of post spinal shivering. | -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. | every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| change in the basal axillary temperature. | Changes in basal axillary temperature (Celsius (°C) scale) of the patient after administration of tested drugs. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minya University Faculty of Medicine | Minya | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D017829 | Granisetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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| Drug |
label sticker |
|
| Placebo | Other | label sticker |
|
| change in the basal mean arterial blood pressure |
Changes in the basal non-invasive mean arterial blood pressure( millimetres mercury (mmHg)) of the patient after administration of tested drugs. |
| 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 basal heart rate | Change in the heart rate of the patient after administration of tested drugs (beat per minute) | 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. |
| D053961 |
| Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |