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Spinal anesthesia affects the homeostatic systems resulting in intraoperative hypothermia and subsequently shivering. In fact, shivering may be seen after this technique in 30 to 40% of cases . Ondansetron and Nefopam have been used to prevent intraoperative shivering . However, no prospective, randomized, double-blind study has been conducted to this date in order to compare nefopam with ondansetron in the prevention of post-spinal anesthesia shivering.
The primary objective of this prospective, randomized, double-blind study is to compare the incidence and intensity of shivering after spinal anesthesia for non-obstetric surgery in 2 groups of patients.
Group A: Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients).
• Group B: Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Ondansetron | Active Comparator |
| |
| Patients receiving Nefopam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron 8mg | Drug | Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of shivering | Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes. | Shivering score was noted every 15 minutes from drug administration up to 120 minutes. |
| Grade of shivering | Grades of shivering will be noted every 15 minutes from drug administration up to 120 minutes. Shivering will be graded : 0 = no shivering, 1= piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 = shivering involving the whole body. | Shivering score was noted every 15 minutes from drug administration up to 120 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea/Vomitting | Number of episodes of nausea and/or vomiting during and after surgery. | Every 15 minutes from drug administration up to 120 minutes |
| Hypotention/Bradycardia | Hypotention: Number of episodes of hypotension SBP <90mmhg or <25% of baseline SBP in post spinal anesthesia until discharge from the PACU. Bradycardia: Number of episodes of bradycardia <50 / min post-spinal anesthesia until discharge from the PACU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Dagher, MD | Contact | +9613477332 | chdagher@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universite Saint Joseph , Hotel Dieu de France | Recruiting | Beirut | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30226340 | Background | Kang P, Park SK, Yoo S, Hur M, Kim WH, Kim JT, Bahk JH. Comparative effectiveness of pharmacologic interventions to prevent shivering after surgery: a network meta-analysis. Minerva Anestesiol. 2019 Jan;85(1):60-70. doi: 10.23736/S0375-9393.18.12813-6. Epub 2018 Sep 18. | |
| 18433676 | Background | Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006. |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nefopam Injectable Solution | Drug | Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients) |
|
| Every three minutes from drug administration up to 120 minutes. |
| Pain on injection site by analogue visual scale. | Pain upon administration of drug on site of injection will be assessed using the analogue visual scale . | During administration of drug. |
| 11949644 | Background | Mathews S, Al Mulla A, Varghese PK, Radim K, Mumtaz S. Postanaesthetic shivering--a new look at tramadol. Anaesthesia. 2002 Apr;57(4):394-8. doi: 10.1046/j.1365-2044.2002.2457_3.x. |
| 26055978 | Background | Lv M, Wang X, Qu W, Liu M, Wang Y. Nefopam for the prevention of perioperative shivering: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2015 Jun 9;15:87. doi: 10.1186/s12871-015-0068-y. |
| 27212768 | Background | Rai S, Verma S, Pandey HP, Yadav P, Patel A. Role of butorphanol and ondansetron premedication in reducing postoperative shivering after general and spinal anesthesia: A randomized comparative study from North India. Anesth Essays Res. 2016 May-Aug;10(2):319-23. doi: 10.4103/0259-1162.172724. |
| 24790900 | Background | Marashi SM, Soltani-Omid S, Soltani Mohammadi S, Aghajani Y, Movafegh A. Comparing Two Different Doses of Intravenous Ondansetron With Placebo on Attenuation of Spinal-induced Hypotension and Shivering. Anesth Pain Med. 2014 Mar 18;4(2):e12055. doi: 10.5812/aapm.12055. eCollection 2014 May. |
| 11682416 | Background | Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052. |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |