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

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

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)

Study Overview

• Status: Unknown
• Conditions: Stress
• Intervention / Treatment: Drug: Fentanyl; Drug: Propofol

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• In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters: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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: May M Abdalla; Phone Number: (002) 01002662985; Email: mayezzeldin@miuegypt.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Kasr al aini
    • Contact: Tarek A Radwan; Phone Number: (002) 0122210277; Email: dtradwan@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: propofol; 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; I.V propofol
Active Comparator: propofol and fentanyl; 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: Fentanyl; Other Names: propofol; Drug: Propofol; I.V 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	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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: propofol, BIS, general anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Propofol
• Other Study ID Numbers: PT (1490)