StressPhase 2/3NCT03143933
Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Stress Response
A Phase 2/3 study testing Propofol and Fentanyl in people with Stress, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress
- What is being tested?
- Propofol and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Sep 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA1
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Aini
Cairo
Tarek A Radwan, (002) 0122210277, dtradwan@yahoo.com
About this study
Official title: Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Surgical Stress Response Using BIS
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)
Read the 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:
- Conditions
- Stress
- Keywords
- propofol, BIS, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Propofol; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: heart rate readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, May Mohamed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143933
- Sponsor's protocol ID
- PT (1490)
- Status last verified
- May 2017
- First submitted
- 22 Apr 2017
- Last updated
- 8 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between IV Propofol and Propofol/ Fentanyl Anesthesia on Patients Surgical Stress Response Using BIS
- ClinicalTrials.gov ID
- NCT03143933
- Acronym / sponsor ID
- PT (1490)
- Conditions
- Stress
- Keywords
- propofol, BIS, general anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: Propofolthis 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 |
| propofol and fentanyl | Active comparator | Drug: Propofol, Drug: Fentanylthis 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA1
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolI.V propofol | Drug | propofol, propofol and fentanyl |
| FentanylAlso: propofol | Drug | propofol and fentanyl |
Primary outcome
Primary end point; assessment of change in blood biochemical indicators of surgical stress
Time frame: blood sample will withdrawn before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins
blood testing includes: Catecholamines 1. Epinephrine 2. Nor epinephrine , Fasting blood glucose, Insulin level, Cortisol, Vasopressin, and Cytokines
3 secondary outcomes
Secondary end point; assessment of change in BIS number
Time frame: 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
Time frame: 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
Time frame: heart rate readings will be recorded before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propofol and Fentanyl in people with Stress, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact May M Abdalla ((002) 01002662985, mayezzeldin@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary end point; assessment of change in blood biochemical indicators of surgical stress (time frame: blood sample will withdrawn before induction of anesthesia with 10 mins and after induction of anesthesia with 3 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.