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

NCT03143933 | Unknown Phase 2

• 1 other identifier: PT (1490)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Stress

Keywords

propofol, BIS, general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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  blood sample will withdrawn before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins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 Outcomes (3)

• 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

Study Arms (2)

propofol

ACTIVE COMPARATOR

this arm will receive propofol in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins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

propofol and fentanyl

ACTIVE COMPARATOR

this arm will receive propofol and fentanyl in induction of anesthesia and blood sample will be withdrawn before induction and another sample will be withdrawn after induction with 3 mins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

Interventions

Propofol DRUG

I.V propofol

propofol; propofol and fentanyl

Fentanyl DRUG

Also known as: propofol

propofol and fentanyl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA1

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Aini

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Propofol; Fentanyl

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

May M Abdalla

CONTACT

(002) 01002662985; mayezzeldin@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: April 22, 2017
• First Posted: May 8, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

EG (1)