Shivering
Conditions
Keywords
Shivering, Anesthesia, Spinal, Caesarean
Brief summary
The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.
Interventions
DRUGTramadol with Ketamine
Tramadol with Ketamine is being provided randomly using prospective, double-blind
DRUGTramadol
Tramadol alone is being provided randomly using prospective, double-blind
Sponsors
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 to 40 years * American Society of Anesthesiologist physical status I and II * Pregnant female for lower segment caeserian section
Exclusion criteria
* Patients with Hypertension * Patients with hypo- or hyperthyroidism * Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia * An initial body temperature 38.00C or, 36.0oC assessed by thermometer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of shivering | Patients will be monitored from 15-45 mins from the administration of the prophylactic drug | Muscular activity in one or more than one muscle group or involving the whole body will be labelled as shivering |
| Severity of Shivering | Patients will be monitored from 15-45 mins from the administration of the prophylactic drug | Shivering will be graded as per the following criteria: 0= no shivering. 1. piloerection or peripheral vasoconstriction but no visible shivering. 2. muscular activity (visible muscular twitching) in only one muscle group; 3. muscular (visible muscular twitching) activity in more than one muscle group but not generalized. 4. shivering involving the whole body |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to shivering | 15 mins from the administration of the prophylactic drug | The time to shiver will be defined as the duration from the initiation of the intervention until the onset of observable shivering. |
| Complications | Patients will be monitored from 15-45 mins from the administration of the prophylactic drug | Complications such as hypotension, nausea and vomiting, bradycardia, or hallucinations will be noted |
Countries
Pakistan
Contacts
Primary ContactMuhammad Arif
Outcome results
None listed