Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Correction of Post-spinal anesthesia hypotension by fluids pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering. In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.

Detailed Description
-----------------
Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgery. Spinal anesthesia avoids the risks of general anesthesia such as aspiration of gastric contents and difficulty with airway management. Post-spinal anesthesia hypotension in elderly patients is challenging. Correction of Post-spinal anesthesia hypotension by fluids either colloids or crystalloids or by vasoconstrictors pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance. Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering. Avoidance of complications of opioids is a great issue as, postoperative nausea, vomiting, respiratory depression, urinary retention, prolonged hospital stay and immunosuppression. In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.

Official Title
-----------------
Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery

Conditions
-----------------
Dexamethasone, Urologic Endoscopic Surgery

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Bupivacaine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: > 60 years old Gender: Males and females ASA grade I - II - III Patients undergoing elective endoscopic urological procedures. Exclusion Criteria: Patient refusal. Suspected massive bleeding. Transition to open abdominal surgery

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug arm<br>45 patients will receive 8mg dexamethasone in addition to bupivacaine intrathecally . | Drug: Dexamethasone<br>* 8 mg intrathecally<br>Drug: Bupivacaine Hydrochloride<br>* 0.5 % intrathecally<br>|
| Other: control arm<br>45 patients will receive only bupivacaine intrathecally as a control group. | Drug: Bupivacaine Hydrochloride<br>* 0.5 % intrathecally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of fluids | Total amount of fluids needed to maintain mean blood pressure more than 65 mmHg | intraoperative | 
| Total amount of vasoactive drugs | Total amount of vasoactive drugs needed to maintain mean blood pressure more than 65 mmHg | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | systolic and diastolic blood pressure and mean arterial blood pressure. | Intraoperative and up to 1hour postoperative | 
| Post-operative VAS score of pain assessment. | Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-no pain on the left end (0 cm) of the scale and the worst pain on the right end of the scale (10 cm). | Up to one hour postoperative | 
| Post-operative shivering. | shivering of the patient | Up to 6 hours postoperatively. | 
| Post-operative nausea and vomiting. | The presence of nausea or vomiting 6 hours post operatively | Up to 6 hours postoperatively. | 
| Post dural puncture headache. | headache during 2 days postoperative and detection of severity and response to treatment | Up to 2 days postoperative |