Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Stress Response

Study Overview
=================
Brief Summary
-----------------
It is hypothesized that propofol, when used in general anesthesia (GA) influence patient's stress status and consequently affect stress response parameters. Hence, the objective of the presented research is to assess whether the propofol has anti-stress effect or not in patients undergoing surgeries that require GA and classified as The American Society of Anesthesiologists physical status 1 (ASA PS1)

Detailed Description
-----------------
Forty patients will be divided into two groups of patients (n=20 each), where in the first group anesthesia induction will be with propofol as a single agent, while patients in the second group will be anesthetized by propofol/fentanyl and the depth of anesthesia will be determined by BIS score and will be kept at 40-60. In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters: I- Hemodynamic indicators II- Catecholamines . III- Fasting blood glucose IV- Insulin level V- Cortisol VI- Vasopressin VII- Cytokines:

Official Title
-----------------
Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Surgical Stress Response Using BIS

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA1 Exclusion Criteria: Patients who refused to participate in the study or to sign the consent form The very young and very old patients Severely agitated (panicked). ASA1 patients who had bradycardia during propofol induction and was reversed with atropine. Patients with any of the following pathologies: liver, kidney, lung, or cardiac diseases, allergic to medicines, alcohol abuse, pregnant, or having endocrine or neuropsychiatric diseases. Moreover, those with sepsis syndrome with hemodynamic instability, hypothermia, and poorly controlled coagulopathy will not be enrolled in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol<br>this arm will receive propofol in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins | Drug: Propofol<br>* I.V propofol<br>|
| Active Comparator: propofol and fentanyl<br>this arm will receive propofol and fentanyl in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins | Drug: Propofol<br>* I.V propofol<br>Drug: Fentanyl<br> <br> * Other names: propofol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary end point; assessment of change in blood biochemical indicators of surgical stress | blood testing includes: Catecholamines 1. Epinephrine 2. Nor epinephrine , Fasting blood glucose, Insulin level, Cortisol, Vasopressin, and Cytokines | blood sample will withdrawn before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary end point; assessment of change in BIS number |  | BIS readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins | 
| Tertiary end point; assessment of change in blood pressure |  | blood pressure readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins | 
| Quaternary end point; assessment of change in heart rate |  | heart rate readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propofol, BIS, general anesthesia