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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-09-30

Brief Summary

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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)

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Detailed Description

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* In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters: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

Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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this arm will receive propofol in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

I.V propofol

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this arm will receive propofol and fentanyl in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

I.V propofol

Fentanyl

Intervention Type DRUG

Interventions

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Propofol

I.V propofol

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Other Intervention Names

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propofol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No