Shivering, Adverse Effects in the Therapeutic Use of Anaesthetic
Conditions
Brief summary
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)
Interventions
DRUGOndansetron 8mg
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).
DRUGNefopam Injectable Solution
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)
Sponsors
Saint-Joseph University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age between 18 and 65 years * scheduled for a surgery under spinal anesthesia
Exclusion criteria
* pregnant or breastfeeding (for the women), if they are * Allergy to any of the drugs to be used * Long QT syndrome * Hepatic insufficiency * Renal failure * Parkinson's disease * Epilepsy * Glaucoma * Phenylketonuria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of shivering | Shivering score was noted every 15 minutes from drug administration up to 120 minutes. | Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes. |
| Grade of shivering | Shivering score was noted every 15 minutes from drug administration up to 120 minutes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea/Vomitting | Every 15 minutes from drug administration up to 120 minutes | Number of episodes of nausea and/or vomiting during and after surgery. |
| Hypotention/Bradycardia | Every three minutes from drug administration up to 120 minutes. | 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. |
| Pain on injection site by analogue visual scale. | During administration of drug. | Pain upon administration of drug on site of injection will be assessed using the analogue visual scale . |
Countries
Lebanon
Contacts
Primary ContactChristine Dagher, MD
Outcome results
None listed