Anti-shivering Effect of Ondansetron

Study Overview
=================
Brief Summary
-----------------
Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect

Detailed Description
-----------------
Shivering is one of the most frequent complications occurring during or after spinal anesthesia, it affects about 40%-60 % of patients under spinal anesthesia. Intra and Post spinal shivering is distressing for the patients and anesthetist. Shivering may aggravate medical conditions in patients with limited cardiac or respiratory functions. It increases tissue oxygen demand many folds which in turn leads to increase the load on respiratory and cardiac systems to cope with increased aerobic metabolism. Shivering interferes with good patient monitoring by causing artifacts of electrocardiography, invasive and non-invasive blood pressure, pulse oximetry, etc... . Postoperatively shivering may cause discomfort to the patient, increases wound pain by stretching incision, increase the incidence of bleeding and infection. We aim to compare the prophylactic use of two different doses of ondansetron on the incidence of shivering after spinal anesthesia in patients scheduled for lower limb surgery. The primary outcome was percentage of patients suffering from shivering after spinal anesthesia, secondary outcomes include any side effects related to both doses.

Official Title
-----------------
Comparison Between Two Different Doses of Ondansetron on the Incidence of Spinal Shivering During Cesarean Section

Conditions
-----------------
Ondansetron, Shivering

Intervention / Treatment
-----------------
* Drug: Normal saline
* Drug: Ondansetron 4 MG
* Drug: Ondansetron 8mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-65 years Both sexes American Society of Anesthesiologists physical status I and II scheduled for lower limb surgery under spinal anesthesia Exclusion Criteria: Uncooperative patients psychologically unstable patients obese patients with BMI >30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal saline<br>patients received normal saline for prevention of shivering during spinal anesthesia | Drug: Normal saline<br>* normal saline used for prevention of spinal shivering<br>* Other names: placebo;|
| Active Comparator: ondansetron 4MG<br>patients received 4 mg of ondansetron for prevention of spinal shivering | Drug: Ondansetron 4 MG<br>* ondansetron 4 MG used for prevention of spinal shivering<br>* Other names: low ondansetron;|
| Active Comparator: ondansetron 8MG<br>patients received 8 mg of ondansetron for prevention of spinal shivering | Drug: Ondansetron 8mg<br>* ondansetron 8 MG used for prevention of spinal shivering<br>* Other names: high ondansetron;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of shivering | Incidence of shivering among patients in both groups | for 24 hours after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary temperature | patient temperature measured from axillary site | for 24 hours after spinal anesthesia | 
| core temperature | patient temperature measured from tympanic site | for 24 hours after spinal anesthesia | 
| incidence of hypotension | Incidence of hypotension between patients in both groups | for 24 hours after spinal anesthesia | 
| incidence of nausea and vomiting | Incidence of nausea and vomiting among patients in both groups | for 24 hours after spinal anesthesia |