Anesthesia, GeneralNCT04729465
The Effect of BIS-guided Propofol Induction on Hemodynamic Response in Patients With Cardiac Risk.
A study testing Propofol and Bispectral Index Monitor in people with Anesthesia, General, run by Istanbul University - Cerrahpasa.
Trial summary
Anesthesia induction will be started by monitoring ECG, non-invasive artery monitoring, peripheral oxygen saturation and BIS for all patients who are taken to the operating room without sedation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Propofol and Bispectral Index Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2021to 10 Aug 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with a cardiovascular problem requiring ENT surgery lasting less than 2 hours
Who cannot join
- Patients having history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females were excluded from the study.
About this study
Official title: The Effect of BIS-guided Propofol Induction on the Peroperative and Postoperative Hemodynamic Response in Patients With Cardiac Risk in Ear-nose-throat Surgery.
Anesthesia induction will be started by monitoring ECG, non-invasive artery monitoring, peripheral oxygen saturation and BIS for all patients who are taken to the operating room without sedation. The patients were divided into 2 groups: Group P; Propofol 2 mg / kg bolus (in 10 seconds), Group B; Propofol will be started as an infusion dose of 0,25 mg / kg / min and will be discontinued when the BIS reaches a minimum value of 60. Noninvasive arterial blood pressure and heart rate will be measured at 2-minute intervals during the first 10 minutes of induction and then at 15th , 20th ,30th and 60th minutes peroperatively. Hypotension; mean arterial pressure (MAP) <60 mmHg, bradycardia heart rate <60 / min, hypertension MAP> 120 mmHg and tachycardia heart rate> 100 / min were defined. The difference of changes, their duration, the difference between the maximal value and the baseline value, and the number of occurrences of hypotension, hypertension, and arrhythmias during the entire induction and perioperative period will be recorded. Noninvasive arterial blood pressure and heart rate measurements of the patients will be made in the postoperative period at 5th , 15th , 30th minutes and at 1st , 2nd , 4th , and 24th hours. At the end of the 1st month, it will be questioned whether the patients encounter a cardiovascular problem that will require treatment or hospitalization in the period following the surgery. All patients will be started with 5 ml / kg / hour IV crystalloid infusion. When the MAP falls below 60 mmHg during induction, the patient will be given the Trendelenburg position and the crystalloid infusion will be increased to 10 ml / kg / hour, and vasoconstrictor drug will be added if the hypotension does not improve within the following 10 minutes.
Read the detailed description
surgeries performed on patients participating in the study
minor elective ear nose throat surgery (microlaryngeal surgery, biyopsy for ENT malignancy, myringoplasty)
exclusion criteria;history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females
- Conditions
- Anesthesia, General
- Being tested
- Propofol, Bispectral Index Monitor
- Keywords
- BIS, propofol, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol
Bispectral Index MonitorDevice
Bispectral Index Monitor
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Active Comparator: Control Patients with cardiac disaese receive general anesthesia with Propofol
Interventions:
Drug: Propofol Receives: Drug: Propofol |
| Experimental | Experimental | Experimental: Bispectral Index Monitor Patients with cardiac disease receive a general anesthesia with Propofol where the amount of anesthetics administered is decided taking into consideration the Bispectral Index Monitor.
Interventions:
Drug: Propofol Device: Bispectral Index Monitor Receives: Drug: Propofol; Device: Bispectral Index Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol consumption
amount of Propofol consumption during the induction of anesthesia and perioperative period with or without BIS monitoring
Measured: 30 minutes-2 hours
Secondary outcomes (1)
Hemodynamic alterations
to observe hemodynamic alterations during propofol induction with or without BIS monitoring .
Measured: 30 minutes- 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start8 Feb 2021 (estimated)
- Primary completion10 Jul 2021 (estimated)
- Study completion10 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: Propofol Device : Bispectral Index Monitor
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Yılmazer, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729465
- Sponsor's protocol ID
- 10/01/2020-5208
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BIS-guided Propofol Induction on the Peroperative and Postoperative Hemodynamic Response in Patients With Cardiac Risk in Ear-nose-throat Surgery.
- ClinicalTrials.gov ID
- NCT04729465
- Acronym / sponsor ID
- 10/01/2020-5208
- Conditions
- Anesthesia, General
- Keywords
- BIS, propofol, anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 8 Feb 2021 (estimated)
- Primary completion
- 10 Jul 2021 (estimated)
- Study completion
- 10 Aug 2021 (estimated)
- First posted
- 28 Jan 2021 (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.
Anesthesia induction will be started by monitoring ECG, non-invasive artery monitoring, peripheral oxygen saturation and BIS for all patients who are taken to the operating room without sedation. The patients were divided into 2 groups: Group P; Propofol 2 mg / kg bolus (in 10 seconds), Group B; Propofol will be started as an infusion dose of 0,25 mg / kg / min and will be discontinued when the BIS reaches a minimum value of 60. Noninvasive arterial blood pressure and heart rate will be measured at 2-minute intervals during the first 10 minutes of induction and then at 15th , 20th ,30th and 60th minutes peroperatively. Hypotension; mean arterial pressure (MAP) <60 mmHg, bradycardia heart rate <60 / min, hypertension MAP> 120 mmHg and tachycardia heart rate> 100 / min were defined. The difference of changes, their duration, the difference between the maximal value and the baseline value, and the number of occurrences of hypotension, hypertension, and arrhythmias during the entire induction and perioperative period will be recorded. Noninvasive arterial blood pressure and heart rate measurements of the patients will be made in the postoperative period at 5th , 15th , 30th minutes and at 1st , 2nd , 4th , and 24th hours. At the end of the 1st month, it will be questioned whether the patients encounter a cardiovascular problem that will require treatment or hospitalization in the period following the surgery. All patients will be started with 5 ml / kg / hour IV crystalloid infusion. When the MAP falls below 60 mmHg during induction, the patient will be given the Trendelenburg position and the crystalloid infusion will be increased to 10 ml / kg / hour, and vasoconstrictor drug will be added if the hypotension does not improve within the following 10 minutes.
Detailed description
surgeries performed on patients participating in the study
minor elective ear nose throat surgery (microlaryngeal surgery, biyopsy for ENT malignancy, myringoplasty)
exclusion criteria;history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Drug: Propofol Device : Bispectral Index Monitor
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: PropofolActive Comparator: Control Patients with cardiac disaese receive general anesthesia with Propofol Interventions: Drug: Propofol |
| Experimental | Experimental | Drug: Propofol, Device: Bispectral Index MonitorExperimental: Bispectral Index Monitor Patients with cardiac disease receive a general anesthesia with Propofol where the amount of anesthetics administered is decided taking into consideration the Bispectral Index Monitor. Interventions: Drug: Propofol Device: Bispectral Index Monitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with a cardiovascular problem requiring ENT surgery lasting less than 2 hours
Key exclusion criteria (1 listed)
- Patients having history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females were excluded from the 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 |
|---|---|---|
| PropofolPropofol | Drug | Active Comparator, Experimental |
| Bispectral Index MonitorBispectral Index Monitor | Device | Experimental |
Primary outcome
Propofol consumption
Time frame: 30 minutes-2 hours
amount of Propofol consumption during the induction of anesthesia and perioperative period with or without BIS monitoring
1 secondary outcome
Hemodynamic alterations
Time frame: 30 minutes- 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Related trials for Anesthesia, General
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Bispectral Index Monitor in people with Anesthesia, General, run by Istanbul University - Cerrahpasa.
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 1 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol consumption (time frame: 30 minutes-2 hours). 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 3 Feb 2021.