Clonidine Versus Granisetron for Shivering Prevension

Study Overview
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Brief Summary
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Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption

Detailed Description
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Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering. Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine. We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.

Official Title
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Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section

Conditions
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Post Spinal Anesthesia Shivering

Intervention / Treatment
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* Drug: Clonidine Injection
* Drug: Granisetron Injection
* Drug: Normal Saline 10 mL Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient acceptance.,Aged between 21-40 years old, BMI: 18- 30 kg/m2, ASA: I and II., Scheduled for elective cesarean section under spinal anesthesia. - Exclusion Criteria: History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Cl (clonidine group)<br>will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia | Drug: Clonidine Injection<br>* intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia<br>|
| Active Comparator: Group G (granisetron group)<br>will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia. | Drug: Granisetron Injection<br>* intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.<br>|
| Placebo Comparator: Group C (control group)<br>will be given intravenous10ml normal saline 20 minutes before spinal anesthesia | Drug: Normal Saline 10 mL Injection<br>* intravenous 10 ml normal saline 20 minutes before spinal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Shivering | • Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body | Procedure (through out the period of spinal anesthesia) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| core body temperature | Core body temperature was detected by measuring tympanic membrane temperature using digital infrared ear thermometer (thermoscan KFT-10; Grnzia, genova, Italy). | Procedure (preoperative as base and through out the period of spinal anesthesia) | 
| Maternal Heart rate | beats/minute | Procedure (preoperative as base and through out the period of spinal anesthesia) | 
| baby APGAR score |  | 1 minutes and 5 minutes post natal | 
| maternal blood presure | mmhg | Procedure (preoperative as base and through out the period of spinal anesthesia) |