AnesthesiaNCT06535230
Anesthesia Induction with the Target-controlled Infusion of Propofol in High-risk Patients
A study testing Manual anesthesia induction and Hemodynamic monitoring with pressure recording analytical method (PRAM) in people with Anesthesia and Hemodynamic Instability, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the risk of hypotension following induction of anesthesia in high-risk patients (American Society of Anesthesiologists risk scores III and IV) using target-controlled infusion (TCI) of propofol versus standard manual induction of anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anesthesia, Hemodynamic Instability
- What is being tested?
- Manual anesthesia induction and Hemodynamic monitoring with pressure recording analytical method (PRAM)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2024to 30 Jun 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the American Society of Anesthesiology physical status 3-4
- Underwent major elective surgery
- Required intra-arterial blood pressure monitoring before induction.
Who cannot join
- Under 18 years of age
- Patients with the American Society of Anesthesiology physical status 1-2
- Arrhythmia (atrial fibrillation, frequent premature beat)
- Severe valvular heart disease
- Morbid obesity
- Intubation difficulty
Show all 10Show fewer
- Drug addiction
- Treatment with opiates
- Pregnancy
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Zeynep Tugce Sarikaya, M.D. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Altunizade Hospital
Istanbul
Serap Aktas Yildirim, MD, +905325605077, serapaktas79@yahoo.com.tr
Zeynep T Sarikaya, MD, tugcesrky@gmail.com
About this study
Official title: Does Induction of Anesthesia with Target-controlled Propofol Infusion Reduce the Risk of Post-induction Hypotension in High-risk Patients?
The purpose of this study is to compare the risk of hypotension following induction of anesthesia in high-risk patients (American Society of Anesthesiologists risk scores III and IV) using target-controlled infusion (TCI) of propofol versus standard manual induction of anesthesia. Our previously published study compared TCI and manual induction of anesthesia in a general patient population and found that hypotension developed less with TCI induction. This study is a continuation of the other study and will be conducted in high-risk patients.
Read the detailed description
Hypotension after induction of anesthesia is a very common condition. Despite well-known risk factors and advanced monitoring techniques, hypotension after induction of anesthesia occurs in approximately 30% of patients. The risk of hypotension increases in patients with comorbidities such as hypertension, heart failure, renal failure, diabetes mellitus, patients with high ASA (American Society of Anesthesiologists ) risk scores, geriatric patients, patients undergoing major surgery, and patients with prolonged fasting periods. In order to prevent post-induction hypotension, the risk factors of the patient (such as comorbidities, and surgery) cannot be changed, but this risk can be reduced with different anesthesia induction techniques.
Since anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight in standard anesthesia induction, it may cause hypotension in patients with low cardiovascular performance.
The fall in blood pressure is due to a decrease in systemic vascular resistance or cardiac output and may be increased by the concomitant use of other drugs such as remifentanil. Target-controlled infusions (TCI) have been developed to overcome these drawbacks of standard anesthesia induction and maintenance. TCI systems enable titration of anesthetic agents according to the needs of each patient by using pharmacokinetic models through perfusers with special microprocessors. With these features, TCI can provide better control of hemodynamic variations during induction and maintenance of anesthesia. Patients will undergo hemodynamic monitoring using the pressure analytic recording method (PRAM). The functional hemodynamic data provided by this monitoring technique will allow us to better analyze the causes and consequences of hypotension. In this study, investigators aimed to monitor and compare the hemodynamic effects of TCI induction and manual anesthesia induction through PRAM parameters by monitoring patients with high ASA scores before and after induction. Investigators anticipate that these 2 technologies (TCI and PRAM) can provide a better hemodynamic profile in the high-risk patient group with high ASA scores thanks to the advanced monitoring provided to the patient in our anesthesia practice.
- Conditions
- Anesthesia, Hemodynamic Instability
- Being tested
- Manual anesthesia induction, Anesthesia induction with Target controlled infusions (TCI), Hemodynamic monitoring with pressure recording analytical method (PRAM)
- Keywords
- Anesthesia induction, Post-induction hypotension, Target controlled infusions, High-risk patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual anesthesia inductionDrug
Also called Manuel induction
In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight
Anesthesia induction with Target controlled infusions (TCI)Drug
Also called TCI induction
Target controlled infusion (TCI) system aims to reach the theoretically targeted blood or brain concentration of anesthetic agents based on the patient's age, weight, and height, with computer-assisted algorithms.
Hemodynamic monitoring with pressure recording analytical method (PRAM)Device
The pulse contour device MostCare (Vytech, Vygon, Padova, Italy) provides functional hemodynamic monitoring using the pressure recording analytical method.
| Study group | Role | What they receive |
|---|---|---|
| Patients who were assigned to have manual anesthesia induction group with propofol | Active comparator | Patients who were assigned to have a manual anesthesia induction group, propofol was administered 1-2 mg/kg in 1-2 minutes to achieve a level of hypnosis measured by bispectral index ( BIS ) of 35-60 Receives: Drug: Manual anesthesia induction; Device: Hemodynamic monitoring with pressure recording analytical method (PRAM) |
| Patients who were assigned to have target controlled infusions ( TCI) induction with propofol | Active comparator | Patients who were assigned to have TCI induction had the target effect site concentration (Ce) of propofol (Ce) set at 1 μg ml-1 using the Schneider model and subsequently modified to achieve and maintain a level of hypnosis measured by BIS of 35-55 Receives: Drug: Anesthesia induction with Target controlled infusions (TCI); Device: Hemodynamic monitoring with pressure recording analytical method (PRAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic arterial pressure (SAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
Systolic arterial pressure (SAP- mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SAP is a parameter used to assess the pressure of the arterial system during cardiac systole
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Diastolic arterial pressure (DAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
Diastolic arterial pressure (DAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Mean arterial pressure (MAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
Mean arterial pressure (MAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). MAP is a parameter used to assess organ perfusion
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Secondary outcomes (7)
Arterial elastance (Ea) measured before anesthesia induction was investigated whether is a predictive parameter for post-induction hypotension in patients undergoing general anesthesia with TCI or manual
Ea ((mmHg m-2ml-1)is an indicator of cardiac afterload and arterial tone and can be calculated by the ratio of the end-systolic pressure (ESP) and stroke volume (SV) obtained from arterial wave analysis. Ea was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy) before the anesthesia induction
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Stroke volume variation (SVV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI and manual
Stroke volume variation (SVV,%), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SVV is a parameter used to asses cardiac preload and fluid responsiveness
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Pulse pressure variation (PPV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Pulse pressure variation (PPV,%) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). PPV is a parameter used to asses cardiac preload and fluid responsiveness.
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac power output (CPO), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Cardiac power output (CPO, Watt) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CPO is a parameter used to asses cardiac reserve
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac index (CI), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Cardiac index (CI, L/min/m2), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CI is a parameter used to asses cardiac stroke volume
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Dp/Dt(mmHg/msn), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). Dp/Dt is a parameter used to asses cardiac contractility
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Heart rate (HR), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Heart rate (HR/bpm) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). HR is a parameter used to assess the cardiac rate.
Measured: The duration of the study was defined from one minute before induction to 10 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start30 Aug 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Acibadem 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, non-blinded, randomized controlled trial. Patients were allocated to 2 groups: Group 1: Patients who underwent manual anesthesia induction Group 2 : Patients who underwent anesthesia induction with target-controlled infusion,
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fevzi Toraman, M.D., Study director, Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535230
- Sponsor's protocol ID
- ATADEK-2024
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saugel B, Sessler DI. Perioperative Blood Pressure Management. Anesthesiology. 2021 Feb 1;134(2):250-261. doi: 10.1097/ALN.0000000000003610. No abstract available.
PubMed 33206118Sessler DI, Khan MZ, Maheshwari K, Liu L, Adegboye J, Saugel B, Mascha EJ. Blood Pressure Management by Anesthesia Professionals: Evaluating Clinician Skill From Electronic Medical Records. Anesth Analg. 2021 Apr 1;132(4):946-956. doi: 10.1213/ANE.0000000000005198.
PubMed 33031346Billard V, Moulla F, Bourgain JL, Megnigbeto A, Stanski DR. Hemodynamic response to induction and intubation. Propofol/fentanyl interaction. Anesthesiology. 1994 Dec;81(6):1384-93. doi: 10.1097/00000542-199412000-00013.
PubMed 7992907Gao Q, Sun L. Hypotension during induction: prediction or prevention? J Anesth. 2020 Apr;34(2):308. doi: 10.1007/s00540-019-02710-9. Epub 2019 Nov 9. No abstract available.
PubMed 31707517Kazama T, Ikeda K, Morita K, Kikura M, Doi M, Ikeda T, Kurita T, Nakajima Y. Comparison of the effect-site k(eO)s of propofol for blood pressure and EEG bispectral index in elderly and younger patients. Anesthesiology. 1999 Jun;90(6):1517-27. doi: 10.1097/00000542-199906000-00004.
PubMed 10360846Yildirim SA, Dogan L, Sarikaya ZT, Ulugol H, Gucyetmez B, Toraman F. Hypotension after Anesthesia Induction: Target-Controlled Infusion Versus Manual Anesthesia Induction of Propofol. J Clin Med. 2023 Aug 14;12(16):5280. doi: 10.3390/jcm12165280.
PubMed 37629322
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Induction of Anesthesia with Target-controlled Propofol Infusion Reduce the Risk of Post-induction Hypotension in High-risk Patients?
- ClinicalTrials.gov ID
- NCT06535230
- Acronym / sponsor ID
- ATADEK-2024
- Conditions
- Anesthesia, Hemodynamic Instability
- Keywords
- Anesthesia induction, Post-induction hypotension, Target controlled infusions, High-risk patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Aug 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 purpose of this study is to compare the risk of hypotension following induction of anesthesia in high-risk patients (American Society of Anesthesiologists risk scores III and IV) using target-controlled infusion (TCI) of propofol versus standard manual induction of anesthesia. Our previously published study compared TCI and manual induction of anesthesia in a general patient population and found that hypotension developed less with TCI induction. This study is a continuation of the other study and will be conducted in high-risk patients.
Detailed description
Hypotension after induction of anesthesia is a very common condition. Despite well-known risk factors and advanced monitoring techniques, hypotension after induction of anesthesia occurs in approximately 30% of patients. The risk of hypotension increases in patients with comorbidities such as hypertension, heart failure, renal failure, diabetes mellitus, patients with high ASA (American Society of Anesthesiologists ) risk scores, geriatric patients, patients undergoing major surgery, and patients with prolonged fasting periods. In order to prevent post-induction hypotension, the risk factors of the patient (such as comorbidities, and surgery) cannot be changed, but this risk can be reduced with different anesthesia induction techniques.
Since anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight in standard anesthesia induction, it may cause hypotension in patients with low cardiovascular performance.
The fall in blood pressure is due to a decrease in systemic vascular resistance or cardiac output and may be increased by the concomitant use of other drugs such as remifentanil. Target-controlled infusions (TCI) have been developed to overcome these drawbacks of standard anesthesia induction and maintenance. TCI systems enable titration of anesthetic agents according to the needs of each patient by using pharmacokinetic models through perfusers with special microprocessors. With these features, TCI can provide better control of hemodynamic variations during induction and maintenance of anesthesia. Patients will undergo hemodynamic monitoring using the pressure analytic recording method (PRAM). The functional hemodynamic data provided by this monitoring technique will allow us to better analyze the causes and consequences of hypotension. In this study, investigators aimed to monitor and compare the hemodynamic effects of TCI induction and manual anesthesia induction through PRAM parameters by monitoring patients with high ASA scores before and after induction. Investigators anticipate that these 2 technologies (TCI and PRAM) can provide a better hemodynamic profile in the high-risk patient group with high ASA scores thanks to the advanced monitoring provided to the patient in our anesthesia practice.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, prospective, non-blinded, randomized controlled trial. Patients were allocated to 2 groups: Group 1: Patients who underwent manual anesthesia induction Group 2 : Patients who underwent anesthesia induction with target-controlled infusion,
| Arm | Type | Receives |
|---|---|---|
| Patients who were assigned to have manual anesthesia induction group with propofol | Active comparator | Drug: Manual anesthesia induction, Device: Hemodynamic monitoring with pressure recording analytical method (PRAM)Patients who were assigned to have a manual anesthesia induction group, propofol was administered 1-2 mg/kg in 1-2 minutes to achieve a level of hypnosis measured by bispectral index ( BIS ) of 35-60 |
| Patients who were assigned to have target controlled infusions ( TCI) induction with propofol | Active comparator | Drug: Anesthesia induction with Target controlled infusions (TCI), Device: Hemodynamic monitoring with pressure recording analytical method (PRAM)Patients who were assigned to have TCI induction had the target effect site concentration (Ce) of propofol (Ce) set at 1 μg ml-1 using the Schneider model and subsequently modified to achieve and maintain a level of hypnosis measured by BIS of 35-55 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with the American Society of Anesthesiology physical status 3-4
- Underwent major elective surgery
- Required intra-arterial blood pressure monitoring before induction.
Key exclusion criteria (10 listed)
- Under 18 years of age
- Patients with the American Society of Anesthesiology physical status 1-2
- Arrhythmia (atrial fibrillation, frequent premature beat)
- Severe valvular heart disease
- Morbid obesity
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 |
|---|---|---|
| Manual anesthesia inductionAlso: Manuel inductionIn manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight | Drug | Patients who were assigned to have manual anesthesia induction group with propofol |
| Anesthesia induction with Target controlled infusions (TCI)Also: TCI inductionTarget controlled infusion (TCI) system aims to reach the theoretically targeted blood or brain concentration of anesthetic agents based on the patient's age, weight, and height, with computer-assisted algorithms. | Drug | Patients who were assigned to have target controlled infusions ( TCI) induction with propofol |
| Hemodynamic monitoring with pressure recording analytical method (PRAM)The pulse contour device MostCare (Vytech, Vygon, Padova, Italy) provides functional hemodynamic monitoring using the pressure recording analytical method. | Device | Patients who were assigned to have manual anesthesia induction group with propofol, Patients who were assigned to have target controlled infusions ( TCI) induction with propofol |
Primary outcome
Systolic arterial pressure (SAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Systolic arterial pressure (SAP- mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SAP is a parameter used to assess the pressure of the arterial system during cardiac systole
Diastolic arterial pressure (DAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Diastolic arterial pressure (DAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole
Mean arterial pressure (MAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Mean arterial pressure (MAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). MAP is a parameter used to assess organ perfusion
7 secondary outcomes
Arterial elastance (Ea) measured before anesthesia induction was investigated whether is a predictive parameter for post-induction hypotension in patients undergoing general anesthesia with TCI or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Stroke volume variation (SVV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI and manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Pulse pressure variation (PPV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac power output (CPO), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac index (CI), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Heart rate (HR), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Background: PubMed 33206118Saugel B, Sessler DI. Perioperative Blood Pressure Management. Anesthesiology. 2021 Feb 1;134(2):250-261. doi: 10.1097/ALN.0000000000003610. No abstract available.
- Background: PubMed 33031346Sessler DI, Khan MZ, Maheshwari K, Liu L, Adegboye J, Saugel B, Mascha EJ. Blood Pressure Management by Anesthesia Professionals: Evaluating Clinician Skill From Electronic Medical Records. Anesth Analg. 2021 Apr 1;132(4):946-956. doi: 10.1213/ANE.0000000000005198.
- Background: PubMed 7992907Billard V, Moulla F, Bourgain JL, Megnigbeto A, Stanski DR. Hemodynamic response to induction and intubation. Propofol/fentanyl interaction. Anesthesiology. 1994 Dec;81(6):1384-93. doi: 10.1097/00000542-199412000-00013.
- Background: PubMed 31707517Gao Q, Sun L. Hypotension during induction: prediction or prevention? J Anesth. 2020 Apr;34(2):308. doi: 10.1007/s00540-019-02710-9. Epub 2019 Nov 9. No abstract available.
- Background: PubMed 10360846Kazama T, Ikeda K, Morita K, Kikura M, Doi M, Ikeda T, Kurita T, Nakajima Y. Comparison of the effect-site k(eO)s of propofol for blood pressure and EEG bispectral index in elderly and younger patients. Anesthesiology. 1999 Jun;90(6):1517-27. doi: 10.1097/00000542-199906000-00004.
- Background: PubMed 37629322Yildirim SA, Dogan L, Sarikaya ZT, Ulugol H, Gucyetmez B, Toraman F. Hypotension after Anesthesia Induction: Target-Controlled Infusion Versus Manual Anesthesia Induction of Propofol. J Clin Med. 2023 Aug 14;12(16):5280. doi: 10.3390/jcm12165280.
- Individual participant dataSharing planned: No
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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.
Zeynep Tugce Sarikaya, M.D. contact
Fevzi Toraman, M.D. study director
Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual anesthesia induction and Hemodynamic monitoring with pressure recording analytical method (PRAM) in people with Anesthesia and Hemodynamic Instability, run by Acibadem University at 1 site in Turkey (Türkiye).
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 10 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 2025. 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 Turkey (Türkiye). 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 Serap A Aktas Yildirim, MD (+905325605077, serapaktas79@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic arterial pressure (SAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual (time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535230, which also lists 6 linked publications.
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 2025; AzTrials last refreshed its copy on 7 Nov 2026.