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This prospective, randomized, controlled, double-blinded study is designed to evaluate the efficacy of nefopam compared to dexmedetomidine and meperidine for the prevention of postspinal anesthesia shivering while minimizing side effects.
Numerous clinical studies have demonstrated that nefopam effectively prevents and treats postoperative shivering after general anesthesia. For instance, a dose of 0.15 mg/kg nefopam is comparable in efficacy to 0.5 µg/kg dexmedetomidine for treating shivering after orthopedic or abdominal surgery. Additionally, 20 mg of nefopam is equally effective as 50 mg of meperidine in preventing shivering following certain neurosurgical procedures . Notably, patients administered nefopam experience less sedation and hypotension compared to those given dexmedetomidine. However, further research is needed to evaluate nefopam's effects on preventing shivering after neuraxial blockades.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nefopam group | Active Comparator | • Group N (n=80) will receive nefopam 0.15 mg/kg i.v. (Nopain®, Medical Union Pharmaceuticals MUP, Ismailia, Egypt, Ampoules of 20 mg/1 ml) |
|
| dexmeditomidine group | Active Comparator | • Group D (n=80) will receive dexmedetomidine 0.5 µg/kg i.v. (Precedex®, Hospira Inc, USA, Vials of 200 mg/2 ml) |
|
| meperidine group | Active Comparator | • Group P (n =80) will receive pethidine (meperidine) 0.5 mg/kg i.v. (Ampoules of 50 mg/1 ml). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nefopam | Drug | efficacy of 3 drugs in preventing post-spinal anesthesia shivering |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of shivering during the whole observation period | shivering score ≥ 3. The shivering score will be assessed at 10-minute intervals after the spinal block and graded by the scale validated by Wrench et al. | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| - Intraoperative hemodynamic variables | - (HR, MAP, SPO2) every 15 minutes | 120 minutes |
| axillary body temperature | every 30 minutes |
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Inclusion Criteria:
Adult patients aged 21-60 undergoing elective lower abdominal, urological, gynecological, lower limb, orthopedic, or plastic surgeries under spinal anesthesia.
Exclusion Criteria:
• Known hypersensitivity to nefopam, dexmedetomidine, or pethidine.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al Aini Hospitals | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41346412 | Derived | Abdelhafez EM, El-Siory W, Turki D, Eissa AA. Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Postspinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries: A Double-Blind Comparative Study. Anesthesiol Res Pract. 2025 Dec 3;2025:4549345. doi: 10.1155/anrp/4549345. eCollection 2025. |
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comparative study
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double blind
|
| 120 minutes |
| recurrent shivering | response to treatment | 120 minutes |
| ID | Term |
|---|---|
| D009340 | Nefopam |
| D008614 | Meperidine |
| ID | Term |
|---|---|
| D010079 | Oxazocines |
| D001392 | Azocines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D010880 | Piperidines |
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