Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

Study Overview
=================
Brief Summary
-----------------
Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block. Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not. Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded. Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV

Official Title
-----------------
Can Subarachnoid Dexmedetomidine Decrease the Incidence of Postoperative Nausea and Vomiting and Shivering With Minimal Hemodynamic Instability in CS?

Conditions
-----------------
Intrathecal Dexmedetomidine

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine Injection [Precedex]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically free pregnant Female from 18 to 30 yrs old. Undergoing elective LSCS. Body mass index less than 40. Consenting for sub arachnoid anesthesia. Coagulation profile is within normal ranges. Exclusion Criteria: Emergency LSCS. Patient refusal enrollment in the study. Allergy to the medications. Coagulopathy or anticoagulation drugs. Fetal or Maternal comorbidities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study drug (dexmedetomidine intrathecal)<br>5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section. | Drug: Dexmedetomidine Injection [Precedex]<br>* intrathecal injection of 5 mcg dexmedetomidine<br>|
| Placebo Comparator: Control (saline)<br>0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section. | Drug: Dexmedetomidine Injection [Precedex]<br>* intrathecal injection of 5 mcg dexmedetomidine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of subarachnoid dexmedetomidine on hemodynamic parameters. | Measure heart rate, blood pressure, temperature, oxygen saturation | Two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering. | Note occurrence of postoperative nausea or vomiting and note occurrence of shivering and measure the degree. | Six hours |