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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03143933
• Other study ID #: PT (1490)
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 22, 2017
• Last updated: May 4, 2017
• Start date: July 2016
• Est. completion date: September 2017

Study information

• Verified date: May 2017
• Source: Cairo University
• Contact: May M Abdalla
• Phone: (002) 01002662985
• Email: mayezzeldin[@]miuegypt.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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• In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters: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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress

Intervention

Drug:
• Propofol
I.V propofol
• Fentanyl

Locations

Country	Name	City	State
Egypt	Kasr Al Aini	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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