Effect of Hypotensive Anesthesia on the Perfusion Index

Study Overview
=================
Brief Summary
-----------------
Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Many medications were used to induce hypotension. In this study we will compare the effects of tridil and labetalol on the perfusion.

Detailed Description
-----------------
The purpose of this study to detect the degree of hypotension that helps the surgeon and dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and labetalol infusions on the perfusion.

Official Title
-----------------
Department of Anestheia and Intensive Care Unit,Cairo University

Conditions
-----------------
Controlled Hypotension for Nasal Surgeries

Intervention / Treatment
-----------------
* Combination Product: Massimo device
* Drug: Nitroglycerin drug
* Drug: Labetalol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II males and females aged 18-45 years who were scheduled for Functional Endoscopic sinus surgery (FESS) Exclusion Criteria: uncontrolled hypertension, cerebrovascular disorders, bleeding and coagulation disorders, coronary artery diseases, renal or hepatic diseases or known hypersensitivity to the drugs used and pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nitroglycerin group<br>this group will receive nitroglycerin infusion for controlled hypotension.0.5-5ug/kg/min to keep MAP 55-65mmhg then Massimo device will be attached to the patients when MAP reached the desired level | Combination Product: Massimo device<br>* Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).<br>Drug: Nitroglycerin drug<br>* Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins<br>* Other names: tridil;|
| Active Comparator: labetalol group<br>this group will receive labetalol infusion fo controlled hypotension 0.4-3mg/kg/hr to keep MAP 55-65mmhg.then Massimo device will be attached to the patients when MAP reached the desired level | Combination Product: Massimo device<br>* Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).<br>Drug: Labetalol<br>* Labetalol is an antagonist of adrenergic receptors (a1, b1, b2) which is used as an hypotensive inducer. This drug targets the beta receptors 5 to 10 times more specific than alpha receptors so that minor tachycardia happens<br>* Other names: trendate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perfusion index | perfusion index is an indication of peripheral perfusion | 3hrs | 
| serum lactate level | lactate level is an indication of central perfusion | 3hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical feild score | isan indication of adequacy of controlled hypotension | 3hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
controlled hypotension, perfusion