Hypotension on InductionNCT06787404
Evaluation of Post-Induction Hypotension Treatment with PRAM Method
An observational study of Hypotension on Induction, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- Ephedrine and Noradrenalin
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The investigators choose Gynecological Oncology patients who will operated for gyno-oncological reasons
Who may be able to join
- Above 18 years old
- Operated for Gynecologic Oncological reasons
- BMI<35
Who cannot join
- Refusal to participate in the study
- Additional spinal or epidural anesthesia
- Dementia patients from whom consent could not be obtained
- Atrial fibrillation with a rapid ventricular response
- Patients with difficult ventilation and/or difficult intubation
- Left ventricular ejection fraction (EF) below 30%
Show all 9Show fewer
- Severe aortic valve stenosis
- Obesity (BMI >35)
- Chronic beta-blocker use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-Induction Hypotension Treatment with PRAM Method Data in Gynecologic Oncology Cases
The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases.
Read the detailed description
Post-induction hypotension is defined as hypotension that occurs within the first 20-30 minutes after general anesthesia induction or during the period between anesthesia induction and surgical incision. The global incidence rates are reported to be approximately 10.3%, with some studies indicating rates as high as 66.96%. Post-induction hypotension is associated with increased postoperative morbidity risks, such as acute kidney injury, transient tubular dysfunction, myocardial injury, and the need for postoperative intensive care. However, hypotension is a modifiable and preventable risk factor; its early detection and appropriate treatment can improve patient outcomes.
For this reason, investigators aimed to investigate the repeated dose requirements of alpha-adrenergic drugs, the recurrence of hypotension, and their effects on parameters observed via the MostCare monitor in patients undergoing major gynecologic oncologic surgeries during standard anesthesia induction and maintenance. This investigation focuses on patients experiencing a mean arterial pressure <65 mmHg or a >30% reduction in baseline systolic blood pressure within the first 30 minutes after induction or until surgical incision. Additionally, our secondary aim is to examine other parameters that may be associated with post-induction hypotension.
- Conditions
- Hypotension on Induction
- Being tested
- Ephedrine, Noradrenalin
- Keywords
- Post-induction Hypotension, PRAM, Ephedrine, Noradrenaline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
Also called Ephedrine Group
5 milligrams of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options.
NoradrenalinDrug
Also called Noradrenalin Group
5 micrograms of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine | When post-induction hypotension occurred patients were treated with 5 milligrams ephedrine in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment. Receives: Drug: Ephedrine | |
| Noradrenaline | When post-induction hypotension occurred patients were treated with 5 micrograms noradrenaline in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment. Receives: Drug: Noradrenalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Is there a difference in the need for repeated doses of treatments to reach the target blood pressure in patients who develop post-induction hypotension?"
When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed how many hypotension episodes occured after treatment
Measured: First 30 minutes after anesthesia induction or time to skin incision
"Is there a difference in the time to reach the target blood pressure after treatments in patients who develop post-induction hypotension?"
When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed that is there a difference in the time to reach the target blood pressure after treatments
Measured: First 30 minutes after anesthesia induction or time to skin incision
Secondary outcomes (5)
Systemic vascular resistance (SVR)
To examine the effects of the applied treatments on the systemic vascular resistance from the PRAM method and compare them with each other.
Measured: First 30 minutes after anesthesia induction or time to skin incision
Arterial Elastance (Ea)
To examine the effects of the applied treatments on the Ea from the PRAM method and compare them with each other.
Measured: First 30 minutes after anesthesia induction or time to skin incision
Cardiac Output (CO)
To examine the effects of the applied treatments on the CO from the PRAM method and compare them with each other.
Measured: First 30 minutes after anesthesia induction or time to skin incision
Stroke Volume (SV)
To examine the effects of the applied treatments on the SV from the PRAM method and compare them with each other.
Measured: First 30 minutes after anesthesia induction or time to skin incision
Cardiac Cycle Efficiency (CCE)
To examine the effects of the applied treatments on the CCE from the PRAM method and compare them with each other.
Measured: First 30 minutes after anesthesia induction or time to skin incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Mar 2024
- Primary completion1 Dec 2024
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akgün E Şarer, Ass. Prof., Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787404
- Sponsor's protocol ID
- E2-23-5996
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-Induction Hypotension Treatment with PRAM Method Data in Gynecologic Oncology Cases
- ClinicalTrials.gov ID
- NCT06787404
- Acronym / sponsor ID
- E2-23-5996
- Conditions
- Hypotension on Induction
- Keywords
- Post-induction Hypotension, PRAM, Ephedrine, Noradrenaline
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 22 Jan 2025 (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 goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases.
Detailed description
Post-induction hypotension is defined as hypotension that occurs within the first 20-30 minutes after general anesthesia induction or during the period between anesthesia induction and surgical incision. The global incidence rates are reported to be approximately 10.3%, with some studies indicating rates as high as 66.96%. Post-induction hypotension is associated with increased postoperative morbidity risks, such as acute kidney injury, transient tubular dysfunction, myocardial injury, and the need for postoperative intensive care. However, hypotension is a modifiable and preventable risk factor; its early detection and appropriate treatment can improve patient outcomes.
For this reason, investigators aimed to investigate the repeated dose requirements of alpha-adrenergic drugs, the recurrence of hypotension, and their effects on parameters observed via the MostCare monitor in patients undergoing major gynecologic oncologic surgeries during standard anesthesia induction and maintenance. This investigation focuses on patients experiencing a mean arterial pressure <65 mmHg or a >30% reduction in baseline systolic blood pressure within the first 30 minutes after induction or until surgical incision. Additionally, our secondary aim is to examine other parameters that may be associated with post-induction hypotension.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ephedrine | – | Drug: EphedrineWhen post-induction hypotension occurred patients were treated with 5 milligrams ephedrine in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment. |
| Noradrenaline | – | Drug: NoradrenalinWhen post-induction hypotension occurred patients were treated with 5 micrograms noradrenaline in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators choose Gynecological Oncology patients who will operated for gyno-oncological reasons
Key inclusion criteria (3 listed)
- Above 18 years old
- Operated for Gynecologic Oncological reasons
- BMI<35
Key exclusion criteria (9 listed)
- Refusal to participate in the study
- Additional spinal or epidural anesthesia
- Dementia patients from whom consent could not be obtained
- Atrial fibrillation with a rapid ventricular response
- Patients with difficult ventilation and/or difficult intubation
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 |
|---|---|---|
| EphedrineAlso: Ephedrine Group5 milligrams of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options. | Drug | Ephedrine |
| NoradrenalinAlso: Noradrenalin Group5 micrograms of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options. | Drug | Noradrenaline |
Primary outcome
"Is there a difference in the need for repeated doses of treatments to reach the target blood pressure in patients who develop post-induction hypotension?"
Time frame: First 30 minutes after anesthesia induction or time to skin incision
When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed how many hypotension episodes occured after treatment
"Is there a difference in the time to reach the target blood pressure after treatments in patients who develop post-induction hypotension?"
Time frame: First 30 minutes after anesthesia induction or time to skin incision
When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed that is there a difference in the time to reach the target blood pressure after treatments
5 secondary outcomes
Systemic vascular resistance (SVR)
Time frame: First 30 minutes after anesthesia induction or time to skin incision
Arterial Elastance (Ea)
Time frame: First 30 minutes after anesthesia induction or time to skin incision
Cardiac Output (CO)
Time frame: First 30 minutes after anesthesia induction or time to skin incision
Stroke Volume (SV)
Time frame: First 30 minutes after anesthesia induction or time to skin incision
Cardiac Cycle Efficiency (CCE)
Time frame: First 30 minutes after anesthesia induction or time to skin incision
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Akgün E Şarer, Ass. Prof. study director
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension on Induction, run by Ankara City Hospital Bilkent 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 9 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
"Is there a difference in the need for repeated doses of treatments to reach the target blood pressure in patients who develop post-induction hypotension?" (time frame: First 30 minutes after anesthesia induction or time to skin incision). The study lists 2 primary outcomes in all. 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 5 Mar 2025.