Post-induction HypotensionNCT05671783
Intraoperative Hypotension and Post-anesthesia Care Unit Recovery
An observational study of Post-induction Hypotension and Post Anesthesia Recovery, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-induction Hypotension, Post Anesthesia Recovery, Hypotension
- What is being tested?
- Hemodynamic observation of the patients.
- How many people
- 4,776 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2022to 15 Dec 2022
- Phase
- Observational
- 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 85 years
- All sexes
- Adult, Older adult
Study population: We conducted a data-based observational study. Only routinely documented patient data was considered in the recent study. All patients' preoperative and postoperative recovery room data is recorded in a virtual environment. Data describing consecutive patients were collected until the patient was discharged to a ward. Data included demographics, comorbidities, perioperative hemodynamic parameters, duration of PACU, complications in PACU, and non-planned intensive care admission.
Who may be able to join
- 18 years and older
- Underwent elective surgery
- Received general anesthesia
- Planned overnight stay in the hospital after surgery
Who cannot join
- Under 18 years of age
- Cardiac surgery
- Transplant surgery
- Preoperatively receiving vasoactive drugs
- Patients with mechanical circulatory support
- Pediatric surgery
- Patients from ICU
- Patients with scheduled postoperative ICU admissions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Types of Intraoperative Hypotension and Their Association With Post-anesthesia Care Unit Recovery
The underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications.
Read the detailed description
Background The underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications.
Methods The investigators conducted a data-based observational study that included 4776 patients. Post-induction hypotension (pIOH) is defined as a decrease during the first 20 min after anesthesia induction and maintenance intraoperative hypotension (mIOH) when there is a decrease of blood pressure 20th min after induction, with or without pIOH.
- Conditions
- Post-induction Hypotension, Post Anesthesia Recovery, Hypotension, Intraoperative Hypotension
- Being tested
- Hemodynamic observation of the patients.
- Keywords
- Complication, Intraoperative Hypotension, PACU outcomes, PACU recovery, Hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic observation of the patients.Other
Also called Postoperative clinical observation
For the purposes of this study, we defined intraoperative hypotension as a decrease in mean blood pressure of 30% from baseline for a minimum of 5 minutes, including induction and maintenance of anesthesia. The measuring blood pressure method (noninvasive or invasive) depended on the surgical intervention's invasiveness and the patient's cardiac performance.
As soon as the patients entered the PACU, the responsible nurses started the standard monitoring. Anesthesiologists constantly oversee all actions based on the patient's condition. Clinical observation for respiratory and gastrointestinal problems and all disorders were monitored. When in room air SO2 was <94, we started oxygen treatment with a 4 liter/minute nasal cannula, and in cases of nausea antiemetic was administered. The Modified Aldrete Score was used to discharge the patent.
| Study group | Role | What they receive |
|---|---|---|
| Post-induction hypotension | Post-induction hypotension (pIOH) is a decrease during the first 20 min after anesthesia induction Receives: Other: Hemodynamic observation of the patients. | |
| Maintenance intraoperative hypotension | maintenance intraoperative hypotension (mIOH) when there is a decrease of blood pressure 20th min after induction, with or without pIOH Receives: Other: Hemodynamic observation of the patients. | |
| Normotensive patients | Patients with normotension during surgery. Receives: Other: Hemodynamic observation of the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of IOH types on PACU recovery (Duration)
The underlying causative mechanism that leads to IOH may vary depending on the stage of anesthesia and surgery, which determines different IOH types; therefore recovery after them will differ.
care unit (PACU) recovery, especially duration and complications in the PACU.
Measured: From the preoperative first monitorization of the patient in the operating room until until discharege from the PACU (0-720 minutes).
Secondary outcomes (1)
PACU recovery
Compare the effect of intraoperative hypotension types on PACU recovery to the effect of other factors influencing PACU recovery.
Measured: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start6 May 2022
- Primary completion30 Nov 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-induction HypotensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lerzan Dogan, MD, Study chair, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671783
- Sponsor's protocol ID
- 2022-08/10
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on patients is available.
Publications
Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
PubMed 17667564Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
PubMed 28974066Gregory A, Stapelfeldt WH, Khanna AK, Smischney NJ, Boero IJ, Chen Q, Stevens M, Shaw AD. Intraoperative Hypotension Is Associated With Adverse Clinical Outcomes After Noncardiac Surgery. Anesth Analg. 2021 Jun 1;132(6):1654-1665. doi: 10.1213/ANE.0000000000005250.
PubMed 33177322Waddle JP, Evers AS, Piccirillo JF. Postanesthesia care unit length of stay: quantifying and assessing dependent factors. Anesth Analg. 1998 Sep;87(3):628-33. doi: 10.1097/00000539-199809000-00026.
PubMed 9728843Chen B, Pang QY, An R, Liu HL. A systematic review of risk factors for postinduction hypotension in surgical patients undergoing general anesthesia. Eur Rev Med Pharmacol Sci. 2021 Nov;25(22):7044-7050. doi: 10.26355/eurrev_202111_27255.
PubMed 34859868Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.
PubMed 30027443Dogan L, Yildirim SA, Sarikaya T, Ulugol H, Gucyetmez B, Toraman F. Different Types of Intraoperative Hypotension and their Association with Post-Anesthesia Care Unit Recovery. Glob Heart. 2023 Aug 11;18(1):44. doi: 10.5334/gh.1257. eCollection 2023.
PubMed 37577293
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Types of Intraoperative Hypotension and Their Association With Post-anesthesia Care Unit Recovery
- ClinicalTrials.gov ID
- NCT05671783
- Acronym / sponsor ID
- 2022-08/10
- Conditions
- Post-induction Hypotension, Post Anesthesia Recovery, Hypotension, Intraoperative Hypotension
- Keywords
- Complication, Intraoperative Hypotension, PACU outcomes, PACU recovery, Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,776 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 5 Jan 2023 (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 underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications.
Detailed description
Background The underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications.
Methods The investigators conducted a data-based observational study that included 4776 patients. Post-induction hypotension (pIOH) is defined as a decrease during the first 20 min after anesthesia induction and maintenance intraoperative hypotension (mIOH) when there is a decrease of blood pressure 20th min after induction, with or without pIOH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-induction hypotension | – | Other: Hemodynamic observation of the patients.Post-induction hypotension (pIOH) is a decrease during the first 20 min after anesthesia induction |
| Maintenance intraoperative hypotension | – | Other: Hemodynamic observation of the patients.maintenance intraoperative hypotension (mIOH) when there is a decrease of blood pressure 20th min after induction, with or without pIOH |
| Normotensive patients | – | Other: Hemodynamic observation of the patients.Patients with normotension during surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We conducted a data-based observational study. Only routinely documented patient data was considered in the recent study. All patients' preoperative and postoperative recovery room data is recorded in a virtual environment. Data describing consecutive patients were collected until the patient was discharged to a ward. Data included demographics, comorbidities, perioperative hemodynamic parameters, duration of PACU, complications in PACU, and non-planned intensive care admission.
Key inclusion criteria (4 listed)
- 18 years and older
- Underwent elective surgery
- Received general anesthesia
- Planned overnight stay in the hospital after surgery
Key exclusion criteria (8 listed)
- Under 18 years of age
- Cardiac surgery
- Transplant surgery
- Preoperatively receiving vasoactive drugs
- Patients with mechanical circulatory support
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 |
|---|---|---|
| Hemodynamic observation of the patients.Also: Postoperative clinical observationFor the purposes of this study, we defined intraoperative hypotension as a decrease in mean blood pressure of 30% from baseline for a minimum of 5 minutes, including induction and maintenance of anesthesia. The measuring blood pressure method (noninvasive or invasive) depended on the surgical intervention's invasiveness and the patient's cardiac performance. As soon as the patients entered the PACU, the responsible nurses started the standard monitoring. Anesthesiologists constantly oversee all actions based on the patient's condition. Clinical observation for respiratory and gastrointestinal problems and all disorders were monitored. When in room air SO2 was <94, we started oxygen treatment with a 4 liter/minute nasal cannula, and in cases of nausea antiemetic was administered. The Modified Aldrete Score was used to discharge the patent. | Other | Maintenance intraoperative hypotension, Normotensive patients, Post-induction hypotension |
Primary outcome
Effect of IOH types on PACU recovery (Duration)
Time frame: From the preoperative first monitorization of the patient in the operating room until until discharege from the PACU (0-720 minutes).
The underlying causative mechanism that leads to IOH may vary depending on the stage of anesthesia and surgery, which determines different IOH types; therefore recovery after them will differ. care unit (PACU) recovery, especially duration and complications in the PACU.
1 secondary outcome
PACU recovery
Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 17667564Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
- Background: PubMed 28974066Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
- Background: PubMed 33177322Gregory A, Stapelfeldt WH, Khanna AK, Smischney NJ, Boero IJ, Chen Q, Stevens M, Shaw AD. Intraoperative Hypotension Is Associated With Adverse Clinical Outcomes After Noncardiac Surgery. Anesth Analg. 2021 Jun 1;132(6):1654-1665. doi: 10.1213/ANE.0000000000005250.
- Background: PubMed 9728843Waddle JP, Evers AS, Piccirillo JF. Postanesthesia care unit length of stay: quantifying and assessing dependent factors. Anesth Analg. 1998 Sep;87(3):628-33. doi: 10.1097/00000539-199809000-00026.
- Background: PubMed 34859868Chen B, Pang QY, An R, Liu HL. A systematic review of risk factors for postinduction hypotension in surgical patients undergoing general anesthesia. Eur Rev Med Pharmacol Sci. 2021 Nov;25(22):7044-7050. doi: 10.26355/eurrev_202111_27255.
- Background: PubMed 30027443Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.
- Derived from this study: PubMed 37577293Dogan L, Yildirim SA, Sarikaya T, Ulugol H, Gucyetmez B, Toraman F. Different Types of Intraoperative Hypotension and their Association with Post-Anesthesia Care Unit Recovery. Glob Heart. 2023 Aug 11;18(1):44. doi: 10.5334/gh.1257. eCollection 2023.
- Individual participant dataSharing planned: Yes. Data on patients is available.
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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.
Lerzan Dogan, MD study chair
Acibadem University
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 Post-induction Hypotension and Post Anesthesia Recovery, 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 20 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of IOH types on PACU recovery (Duration) (time frame: From the preoperative first monitorization of the patient in the operating room until until discharege from the PACU (0-720 minutes).). 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 NCT05671783, which also lists 7 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 20 Jan 2023.