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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
150
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).
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)
Universite Saint Joseph , Hotel Dieu de France
Beirut, Lebanon
RECRUITINGIncidence of shivering
Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes.
Time frame: 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.
Time frame: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
Nausea/Vomitting
Number of episodes of nausea and/or vomiting during and after surgery.
Time frame: 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.
Time frame: 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 .
Time frame: During administration of drug.
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