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

Cairo University (CU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Stress

Treatments: Drug: Propofol; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03143933

PT (1490)

Details and patient eligibility

About

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)

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• In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters: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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

propofol

Active Comparator group

Description:

this arm will receive propofol in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins

Treatment:

Drug: Propofol

propofol and fentanyl

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Propofol