Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section

Conditions
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Shivering

Intervention / Treatment
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* Drug: Tramadol with Ketamine
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tramadol with Ketamine<br>Tramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg | Drug: Tramadol with Ketamine<br>* Tramadol with Ketamine is being provided randomly using prospective, double-blind<br>|
| Active Comparator: Tramadol<br>Tramadol 0.5mg/kg | Drug: Tramadol<br>* Tramadol alone is being provided randomly using prospective, double-blind<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shivering, Anesthesia, Spinal, Caesarean