Shivering Caused by Spinal Anesthesia
Conditions
Keywords
Anesthesia, dexmedetomidine, pethidine, shivering, spinal
Brief summary
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.
Detailed description
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.
Interventions
DRUGPethidine 0.4mg/kg
2ml intravenous bolus slowly injected in 2minutes.
DRUGDexmedetomidine
2ml intravenous bolus slowly injected in 2minutes
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of \>60 and \<180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period
Exclusion criteria
* Patients with BMI\>30 kg /m2 * Initial body temperature \>38 C or \<36 C and those with a history of convulsions * Multiple allergies * Thyroid disease * Parkinson's disease * Dysautonomia * Raynaud's syndrome * Hypertension * Coronary artery disease or other cardio-respiratory or neuromuscular pathology * Middle ear pathology * A known history of alcohol use * Treatment with sedative hypnotic agents or vasodilators * Having contraindications to spinal anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shivering response rate (%) | 10 minutes | complete cessation of shivering activity within 10 minutes after study drug injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 6 hours after study drug injection | find for systolic hypotension, hypertension |
| sedation | 6 hours after study drug injection | 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). |
| Postoperative adverse events | 24 hours postoperative | postoperative nausea and vomiting, urine retention, post dural puncture headache ect. |
| peripheral arterial saturation | 6 hours after study drug injection | find for hypoxia |
| diastolic blood pressure | 6 hours after study drug injection | find for diastolic hypertension or hypotension |
Other
| Measure | Time frame | Description |
|---|---|---|
| heart rate | 6 hours after study drug injection | find for bradycardia or tachycardia |
Countries
Egypt
Outcome results
None listed