Shivering Clinical Trial
Official title:
Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section
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.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | November 16, 2023 |
Est. primary completion date | November 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Muhammad Arif | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Ziauddin University |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of shivering | Muscular activity in one or more than one muscle group or involving the whole body will be labelled as shivering | Patients will be monitored from 15-45 mins from the administration of the prophylactic drug | |
Primary | Severity of Shivering | Shivering will be graded as per the following criteria:
0= no shivering. piloerection or peripheral vasoconstriction but no visible shivering. muscular activity (visible muscular twitching) in only one muscle group; muscular (visible muscular twitching) activity in more than one muscle group but not generalized. shivering involving the whole body |
Patients will be monitored from 15-45 mins from the administration of the prophylactic drug | |
Secondary | Time to shivering | The time to shiver will be defined as the duration from the initiation of the intervention until the onset of observable shivering. | 15 mins from the administration of the prophylactic drug | |
Secondary | Complications | Complications such as hypotension, nausea and vomiting, bradycardia, or hallucinations will be noted | Patients will be monitored from 15-45 mins from the administration of the prophylactic drug |
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