Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient.

Official Title
-----------------
Peri-operative Dexmedetomidine Infusion in Mild Pre-eclamptic Patients Undergoing Elective Cesarean Section Under General Anesthesia

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Drug: placebo infusion
* Drug: Dexmedetomidine infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women have mild preeclampsia ( Pre-eclamptic patients will be defined as having hypertension [systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg] accompanied by proteinuria first detected after 20 weeks of gestation). Proteinuria is defined as at least 300 mg protein in 24 h urine collection [or ≥1+ dipstick (30 mg/dl) in a single urine sample] ). American Society of Anesthesiologists (ASA) physical status of II or III. age between 19 and 40 years Exclusion Criteria: patient refusal to consent (obsolete). pre-existing neurological disease or psychic patients. history of cardiac and respiratory system failure. co-existing significant renal or liver disease.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure. | Drug: placebo infusion<br>* Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.<br>|
| Active Comparator: Dex. group<br>Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure. | Drug: Dexmedetomidine infusion<br>* Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative analgesia | through VAS score readings | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress response | mean arterial blood pressure | 24 hours postoperatively | 
| renal function | glomerular filtration rate | 24 hours postoperatively | 
| untoward events | eclampsia, drug side effects (over sedation, hypotension, bradycardia) | 24 hours postoperatively |