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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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03143933
Enrollment
40
Registered
2017-05-08
Start date
2016-07-31
Completion date
2017-09-30
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Keywords

propofol, BIS, general anesthesia

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 * In both groups, blood will be withdrawn to assess the possible effect of these medications on stress by measuring the following parameters: I- Hemodynamic indicators II- Catecholamines .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:

Interventions

DRUGPropofol

I.V propofol

DRUGFentanyl

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary end point; assessment of change in blood biochemical indicators of surgical stressblood sample will withdrawn before induction of anesthesia with 10 mins and after induction of anesthesia with 3 minsblood testing includes: Catecholamines 1. Epinephrine 2. Nor epinephrine , Fasting blood glucose, Insulin level, Cortisol, Vasopressin, and Cytokines

Secondary

MeasureTime frame
Secondary end point; assessment of change in BIS numberBIS 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 pressureblood 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 rateheart rate readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins

Countries

Egypt

Contacts

Primary ContactMay M Abdalla
mayezzeldin@miuegypt.edu.eg(002) 01002662985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026