Hemodynamic Effects of PropofolNCT06651749
Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia.
A study testing Propofol injection in people with Hemodynamic Effects of Propofol, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigators will test the hemodynamic effects of a high dose versus low dose Propofol during induction of anesthesia. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Effects of Propofol
- What is being tested?
- Propofol injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 31 Mar 2025
- Phase
- Interventional
- 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: from 21 years old till 40 years old.
- Patients with ASA classification I and II.
- Undergoing a scheduled elective surgery.
Who cannot join
- Declining to give written informed consent.
- ASA classification III-V.
- Patients with class III (morbid) obesity or more (BMI >40 Kg/m2)
- Patients with severe intraoperative hypotension requiring large volume of intravascular fluid treatment.
- Severe or uncontrolled hypertension (NIBP> 150/100) , congestive heart failure, moderate to severe valvular heart disease , uncontrolled arrhythmia , heart rate>100bpm .
- Significant hepatic or renal disorder.
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- Patients with uncontrolled diabetes mellitus type 1 or type 2(evidenced by autonomic dysfunction or organ complications, ischemic heart disease or cerebrovascular disease).
- Patients who were pregnant (positive pregnancy test) or menstruating.
- Anemia with hemoglobin level <9.0 g/dL
- Hypersensitivity to soybean oil, egg lecithin, or glycerol.
- Medical substance abuse.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university
Cairo, Abbaseya, 11517
hadeer s saied, MBBCH, +201021588208, hadeer.saad@med.asu.edu.eg
hadeer s saied, MBBCH
About this study
Official title: Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia. a Randomized Comparative Trial.
The investigators will test the hemodynamic effects of a high dose versus low dose Propofol during induction of anesthesia.
Read the detailed description
- Preoperative settings:
In the anesthesia clinic, an informed written consent will be obtained from every patient one day before the surgery. All patients will be assessed preoperatively by careful history taking full physical examination, and laboratory evaluation.
- Intraoperative settings:
On the arrival to operation room; standard ASA monitors will be attached automatic blood pressure measurements, five-lead ECG monitor, capnography and finger pulse oximetry will be applied, The baseline value was measured.
Measurement of mean arterial blood pressure by non-invasive blood pressure monitoring(NIBP) at selected time interval would be obtained as follows:
- baseline value( NIBP "systolic, diastolic and mean value" and HR): 1 minute pre-injection
- 1 minute post injection
- 3 minutes post injection
- 5 minutes post injection
- Final value :7 minutes post injection
The investigators will calculate the percentage difference of lowest mean arterial blood pressure from baseline value using the following formula:
(Baseline mean blood pressure - lowest value mean blood pressure)/ Baseline mean blood pressure
- An intravenous infusion of ringer acetate 3ml/kg will be started.
- Pre-oxygenation with 100% O2 on 8 L/min for 3 min via face mask will be started.
- Induction of anesthesia would be done by using propofol dosage according to the group
- Group LDP will receive 1.5mg/kg propofol during induction of anesthesia.
- Group HDP will receive 2.5mg/kg propofol during induction of anesthesia.
- In group LDP, if the patient is still showing signs of awareness or intact eyelash reflex within two minutes post injection, the investigators will add 1mg/kg propofol and the patient will be shifted to the HDP group.
- Fentanyl would be given during induction 2mic/kg IV.
- Atracurium besylate 0.5 mg/kg IV will be given to facilitate tracheal intubation, and anaesthesia will be maintained with 1 to 1.5% isoflurane.
- After orotracheal intubation, mechanical ventilation will be started, controlled mechanical ventilation will be achieved by tidal volumes of 8-10 mL/Kg and frequency of ventilation of up to 12-14 breaths/min to maintain normocapnia: end-tidal pressure CO2 (ET CO2) at the level of 35 ± 5 mm Hg and Positive End Expiratory Pressure (PEEP) of 5-10 cm H2O.
- Supplemental boluses of Atracurium besylate 0.1 mg/kg IV will be administered every 20 minutes to maintain muscle relaxation during surgery. Anaesthesia will be maintained with isoflurane 1-1.5% to maintain the HR and MAP within 20% of pre-induction values and/or Heart Rate (HR) < 85 beats/ min during surgical stimulation.
- Regular automated monitoring : NIBP "systolic, diastolic and mean value" and HR /5minutes
- At the end of the surgery, each patient will be extubated upon meeting the extubation criteria.
- Intraoperatively, any increase or decrease of HR, hypotension or hypertension will be managed as required.
- If the patient sustains Bradycardia (defined as: HR ≤50 bpm for 3 minutes), atropine 0.6 mg/kg increments will be administered till acceptable response.
- If the patient sustains Hypotension (defined as a decrease in systolic blood pressure >20%-30% of baseline value for 3 minutes), administration of ephedrine5-6 mg increments, and fast intravenous fluid bolus (250 ml crystalloids).
- If the patient sustains Hypertension (defined as an increase in systolic blood pressure >20%-30% of baseline value for 3 minutes ), raising the end-tidal isoflurane concentration to 2% and 0.5 μg/kg IV bolus of fentanyl will be administered till acceptable response after exclusion of causes other than sympathetic response to surgical stimulus .
- The whole study period will be attended and supervised by the most skilled person in the study group. c.Postoperative settings: The patients will be transferred to the post-anaesthesia care unit and will be put under observation.
- Conditions
- Hemodynamic Effects of Propofol
- Being tested
- Propofol injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol injectionDrug
hemodynamic changes of a high dose versus low dose propofol during induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| high dose propofol during induction of anesthesia. | Active comparator | this group will be given high dose propofol 2.5mg/kg during induction of anesthesia. Receives: Drug: Propofol injection |
| low dose propofol during induction of anesthesia. | Active comparator | this group will be given low dose propofol 1.5mg/kg during induction of anesthesia. Receives: Drug: Propofol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage difference of lowest mean arterial blood pressure from baseline value.
will
Measured: from injection till 7 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic Effects of PropofolStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadeer S Saied, M.B.B.CH, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651749
- Sponsor's protocol ID
- FMASU MS332/2024
- Status last verified
- May 2024
- First submitted
- 19 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia. a Randomized Comparative Trial.
- ClinicalTrials.gov ID
- NCT06651749
- Acronym / sponsor ID
- FMASU MS332/2024
- Conditions
- Hemodynamic Effects of Propofol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
The investigators will test the hemodynamic effects of a high dose versus low dose Propofol during induction of anesthesia.
Detailed description
- Preoperative settings:
In the anesthesia clinic, an informed written consent will be obtained from every patient one day before the surgery. All patients will be assessed preoperatively by careful history taking full physical examination, and laboratory evaluation.
- Intraoperative settings:
On the arrival to operation room; standard ASA monitors will be attached automatic blood pressure measurements, five-lead ECG monitor, capnography and finger pulse oximetry will be applied, The baseline value was measured.
Measurement of mean arterial blood pressure by non-invasive blood pressure monitoring(NIBP) at selected time interval would be obtained as follows:
- baseline value( NIBP "systolic, diastolic and mean value" and HR): 1 minute pre-injection
- 1 minute post injection
- 3 minutes post injection
- 5 minutes post injection
- Final value :7 minutes post injection
The investigators will calculate the percentage difference of lowest mean arterial blood pressure from baseline value using the following formula:
(Baseline mean blood pressure - lowest value mean blood pressure)/ Baseline mean blood pressure
- An intravenous infusion of ringer acetate 3ml/kg will be started.
- Pre-oxygenation with 100% O2 on 8 L/min for 3 min via face mask will be started.
- Induction of anesthesia would be done by using propofol dosage according to the group
- Group LDP will receive 1.5mg/kg propofol during induction of anesthesia.
- Group HDP will receive 2.5mg/kg propofol during induction of anesthesia.
- In group LDP, if the patient is still showing signs of awareness or intact eyelash reflex within two minutes post injection, the investigators will add 1mg/kg propofol and the patient will be shifted to the HDP group.
- Fentanyl would be given during induction 2mic/kg IV.
- Atracurium besylate 0.5 mg/kg IV will be given to facilitate tracheal intubation, and anaesthesia will be maintained with 1 to 1.5% isoflurane.
- After orotracheal intubation, mechanical ventilation will be started, controlled mechanical ventilation will be achieved by tidal volumes of 8-10 mL/Kg and frequency of ventilation of up to 12-14 breaths/min to maintain normocapnia: end-tidal pressure CO2 (ET CO2) at the level of 35 ± 5 mm Hg and Positive End Expiratory Pressure (PEEP) of 5-10 cm H2O.
- Supplemental boluses of Atracurium besylate 0.1 mg/kg IV will be administered every 20 minutes to maintain muscle relaxation during surgery. Anaesthesia will be maintained with isoflurane 1-1.5% to maintain the HR and MAP within 20% of pre-induction values and/or Heart Rate (HR) < 85 beats/ min during surgical stimulation.
- Regular automated monitoring : NIBP "systolic, diastolic and mean value" and HR /5minutes
- At the end of the surgery, each patient will be extubated upon meeting the extubation criteria.
- Intraoperatively, any increase or decrease of HR, hypotension or hypertension will be managed as required.
- If the patient sustains Bradycardia (defined as: HR ≤50 bpm for 3 minutes), atropine 0.6 mg/kg increments will be administered till acceptable response.
- If the patient sustains Hypotension (defined as a decrease in systolic blood pressure >20%-30% of baseline value for 3 minutes), administration of ephedrine5-6 mg increments, and fast intravenous fluid bolus (250 ml crystalloids).
- If the patient sustains Hypertension (defined as an increase in systolic blood pressure >20%-30% of baseline value for 3 minutes ), raising the end-tidal isoflurane concentration to 2% and 0.5 μg/kg IV bolus of fentanyl will be administered till acceptable response after exclusion of causes other than sympathetic response to surgical stimulus .
- The whole study period will be attended and supervised by the most skilled person in the study group. c.Postoperative settings: The patients will be transferred to the post-anaesthesia care unit and will be put under observation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dose propofol during induction of anesthesia. | Active comparator | Drug: Propofol injectionthis group will be given high dose propofol 2.5mg/kg during induction of anesthesia. |
| low dose propofol during induction of anesthesia. | Active comparator | Drug: Propofol injectionthis group will be given low dose propofol 1.5mg/kg during induction of anesthesia. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: from 21 years old till 40 years old.
- Patients with ASA classification I and II.
- Undergoing a scheduled elective surgery.
Key exclusion criteria (11 listed)
- Declining to give written informed consent.
- ASA classification III-V.
- Patients with class III (morbid) obesity or more (BMI >40 Kg/m2)
- Patients with severe intraoperative hypotension requiring large volume of intravascular fluid treatment.
- Severe or uncontrolled hypertension (NIBP> 150/100) , congestive heart failure, moderate to severe valvular heart disease , uncontrolled arrhythmia , heart rate>100bpm .
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 |
|---|---|---|
| Propofol injectionhemodynamic changes of a high dose versus low dose propofol during induction of anesthesia. | Drug | high dose propofol during induction of anesthesia., low dose propofol during induction of anesthesia. |
Primary outcome
Percentage difference of lowest mean arterial blood pressure from baseline value.
Time frame: from injection till 7 minutes post-injection
will
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
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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.
Hadeer S Saied, M.B.B.CH principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol injection in people with Hemodynamic Effects of Propofol, run by Ain Shams 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 3 inclusion and 11 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 26 Nov 2024. 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.
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 Hadeer S Saied, MBBCH (+201021588208, hadeer.saad@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage difference of lowest mean arterial blood pressure from baseline value. (time frame: from injection till 7 minutes post-injection). 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 26 Nov 2024.