Clinical trial NCT03143933: Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Stress Response
Official title: Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Surgical Stress Response Using BIS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stress
Keywords: propofol, BIS, general anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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* In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters: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:

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.

Primary outcomes:
measure: Primary end point; assessment of change in blood biochemical indicators of surgical stress
timeFrame: blood sample will withdrawn before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins
Secondary outcomes:
measure: Secondary end point; assessment of change in BIS number
timeFrame: BIS readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins
measure: Tertiary end point; assessment of change in blood pressure
timeFrame: blood pressure readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins
measure: Quaternary end point; assessment of change in heart rate
timeFrame: heart rate readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Aini
Study officials:
References: