Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section
- Registration Number
- NCT06134895
- Lead Sponsor
- Ziauddin University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 190
- Age between 18 to 40 years
- American Society of Anesthesiologist physical status I and II
- Pregnant female for lower segment caeserian section
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tramadol with Ketamine Tramadol with Ketamine Tramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg Tramadol Tramadol Tramadol 0.5mg/kg
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Muhammad Arif
🇵🇰Karachi, Sindh, Pakistan