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This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.
Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pethidine 0.4mg/kg iv | Active Comparator | interventional: Pethidine 0.4mg/kg intravenous bolus once to be repeated if shivering incompletely abolished. |
|
| DEX. I | Active Comparator | Interventional:Dexmedetomidine (Precedex) 0.5µg/kg intravenous bolus once to be repeated if shivering incompletely abolished. |
|
| DEX. II | Active Comparator | Interventional: Dexmedetomidine (PRECEDEX) 0.3µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished. |
|
| DEX III | Active Comparator | Interventional: Dexmedetomidine (PRECEDEX) 0.2µg/kg intravenous bolus given once to be repeated if shivering incompletely abolished. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pethidine 0.4mg/kg | Drug | 2ml intravenous bolus slowly injected in 2minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shivering response rate (%) | complete cessation of shivering activity within 10 minutes after study drug injection | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | find for systolic hypotension, hypertension | 6 hours after study drug injection |
| sedation | using an Observer's Assessment of Alertness/Sedation Scale (OAA/SS) (where 5 = Responds readily to name spoken in normal tone, 4 = Lethargic response to name spoken in normal tone, 3 = Responds only after name is spoken loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Does not respond to mild prodding or shaking). |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate | find for bradycardia or tachycardia | 6 hours after study drug injection |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hala S Abdel-Ghaffar, MD | assistant professor in anesthesia, faculty of medicine, Assiut university, Assiut, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospital, Assiut, Egypt | Asyut | Assiut Governorate | 715715 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27228512 | Derived | Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53. |
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| ID | Term |
|---|---|
| D008614 | Meperidine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
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| Dexmedetomidine | Drug | 2ml intravenous bolus slowly injected in 2minutes |
|
|
| 6 hours after study drug injection |
| peripheral arterial saturation | find for hypoxia | 6 hours after study drug injection |
| diastolic blood pressure | find for diastolic hypertension or hypotension | 6 hours after study drug injection |
| Postoperative adverse events | postoperative nausea and vomiting, urine retention, post dural puncture headache ect. | 24 hours postoperative |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D007093 | Imidazoles |
| D001393 | Azoles |