PONVSICKNCT05596695
Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting
A study testing Minimizing blood pressure variability in people with PONV and Blood Pressure, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Intraoperative hypotension is associated with postoperative nausea and vomiting (PONV). Even though the exact mechanism linking PONV and hypotension is still unclear, a reduced intestinal tissue perfusion might trigger nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- PONV, Blood Pressure, Postoperative Recovery
- What is being tested?
- Minimizing blood pressure variability
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2022to 1 Feb 2026
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18-50 years of age at time of surgery
- ASA physical status I and II
- Scheduled for elective minor or moderate risk non-cardiac surgery with expected time of surgery ≥1 hour
Who cannot join
- Patients undergoing emergency surgery
- Scheduled for pheochromocytoma surgery
- Nausea and/or vomiting on the morning before surgery
- Taking anti-emetic drugs
- Pregnancy
- Dysfunction of the vestibular system
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Christian Reiterer, MD, 0043 1 40400 ext. 20760, christian.reiterer@meduniwien.ac.at
About this study
Official title: The Effect of Minimizing Blood Pressure Variability on Postoperative Nausea and Vomiting in Women Undergoing Non-cardiac Surgery With Minor to Moderate Risk - a Prospective Randomized Clinical Trial
Intraoperative hypotension is associated with postoperative nausea and vomiting (PONV). Even though the exact mechanism linking PONV and hypotension is still unclear, a reduced intestinal tissue perfusion might trigger nausea and vomiting. Still to date only limited data evaluating intraoperative blood pressure and the incidence of PONV after general anesthesia exits. Furthermore, the effect of intraoperative blood pressure variability on the incidence of PONV has not been investigated yet. Therefore, we will test our primary hypothesis that the incidence of PONV during the early (0-2h) postoperative period will be minimized by targeting intraoperative blood pressure variability to a SPB of 120±5mmHg by using a continuous vasopressor infusion in female patients undergoing elective minor to moderate risk non-cardiac surgery.
Read the detailed description
Background: Intraoperative hypotension is associated with postoperative nausea and vomiting (PONV). Even though the exact mechanism linking PONV and hypotension is still unclear, a reduced intestinal tissue perfusion might trigger nausea and vomiting. Still to date only limited data evaluating intraoperative blood pressure and the incidence of PONV after general anesthesia exits. Furthermore, the effect of intraoperative blood pressure variability on the incidence of PONV has not been investigated yet. Therefore, we will test our primary hypothesis that the incidence of PONV during the early (0-2h) postoperative period will be minimized by targeting intraoperative blood pressure variability to a SPB of 120±5mmHg by using a continuous vasopressor infusion in female patients undergoing elective minor to moderate risk non-cardiac surgery.
Methods: We will include 272 women between 18 and 50 years of age undergoing minor- to moderate-risk noncardiac surgery in this randomized, double-blinded clinical trial. Patients will randomly be assigned to intraoperative management of blood pressure with a SPB of 120±5mmHg (intervention group) or standard of care intraoperative blood pressure management (control group). Our primary outcome will be the incidence of PONV during the early (0-2h) postoperative period between the groups. Nausea will be assessed in 15-min intervals in the PACU for the first two postoperative hours on a 100mm visual analog scale. A PONV episode will be defined as the occurrence of nausea (VAS 50mm or greater) or vomiting.
Statistics: The primary outcome, the incidence of PONV during the early (0-2 hours) postoperative period will be compared between the intervention and control group using a Chi- Square-Test.
Level of originality: Data regarding the effects of intraoperative blood pressure on PONV are very limited and mainly available from retrospective analysis. So far, the effects of blood pressure variability on PONV have not been investigated yet. As PONV is still one of the most common complications after general anaesthesia leading to delayed discharge from PACU, patient discomfort and increased medical costs, it is important to search for additional methods to manage PONV. Our patient population, being at increased risk of PONV, could therefore profit from a more rapid postoperative recovery.
- Conditions
- PONV, Blood Pressure, Postoperative Recovery
- Being tested
- Minimizing blood pressure variability
- Keywords
- Blood Pressure Variability, Minor- to moderate-risk noncardiac surgery
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimizing blood pressure variabilityOther
Intraoperative blood pressure management will be performed to maintain a systolic blood pressure of 120 ±5mmHg using a continuous infusion of a vasopressor starting at induction of anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intraoperative blood pressure management will be performed to maintain a systolic blood pressure of 120 ±5mmHg using a continuous infusion of a vasopressor starting at induction of anesthesia. Receives: Other: Minimizing blood pressure variability |
| Standard of Care Group | No intervention | Intraoperative blood pressure management will be performed according to local clinical standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV
Incidence of postoperative nausea and vomiting within the first two postoperative hours.
Measured: First two postoperative hours
Secondary outcomes (3)
Secondary Outcome 1: Late PONV
Incidence of postoperative nausea and vomiting within the first three postoperative days
Measured: First three postoperative days
Secondary Outcome 2: Modified Aldrete Score
A score to assess readiness of discharge from postanesthesia care unit (PACU). Patients can achieve 0-14 points in the modified Aldrete Score. A modified Aldrete Score > 12 points signals that criteria for discharge from PACU have been fulfilled, a modified Aldrete Score < 12 points signals that patients should stay in PACU.
Measured: First two postoperative hours
Secondary Outcome 3: Ready for Hospital Discharge Scale
A score to evaluate patients' subjective readiness for hospital discharge. Patients can achieve 0-80 points in the Ready for Hospital Discharge Scale. Higher scores mean that patients are ready for hospital discharge, lower scores mean that patients are not ready for hospital discharge.
Measured: First three postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Reiterer, Medical University of Vienna
- Investigators
- Christian Reiterer, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596695
- Sponsor's protocol ID
- SICK_01
- Acronym
- SICK
- Status last verified
- Jul 2023
- First submitted
- 24 Oct 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share any individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Minimizing Blood Pressure Variability on Postoperative Nausea and Vomiting in Women Undergoing Non-cardiac Surgery With Minor to Moderate Risk - a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05596695
- Acronym / sponsor ID
- SICK / SICK_01
- Conditions
- PONV, Blood Pressure, Postoperative Recovery
- Keywords
- Blood Pressure Variability, Minor- to moderate-risk noncardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 27 Oct 2022 (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.
Intraoperative hypotension is associated with postoperative nausea and vomiting (PONV). Even though the exact mechanism linking PONV and hypotension is still unclear, a reduced intestinal tissue perfusion might trigger nausea and vomiting. Still to date only limited data evaluating intraoperative blood pressure and the incidence of PONV after general anesthesia exits. Furthermore, the effect of intraoperative blood pressure variability on the incidence of PONV has not been investigated yet. Therefore, we will test our primary hypothesis that the incidence of PONV during the early (0-2h) postoperative period will be minimized by targeting intraoperative blood pressure variability to a SPB of 120±5mmHg by using a continuous vasopressor infusion in female patients undergoing elective minor to moderate risk non-cardiac surgery.
Detailed description
Background: Intraoperative hypotension is associated with postoperative nausea and vomiting (PONV). Even though the exact mechanism linking PONV and hypotension is still unclear, a reduced intestinal tissue perfusion might trigger nausea and vomiting. Still to date only limited data evaluating intraoperative blood pressure and the incidence of PONV after general anesthesia exits. Furthermore, the effect of intraoperative blood pressure variability on the incidence of PONV has not been investigated yet. Therefore, we will test our primary hypothesis that the incidence of PONV during the early (0-2h) postoperative period will be minimized by targeting intraoperative blood pressure variability to a SPB of 120±5mmHg by using a continuous vasopressor infusion in female patients undergoing elective minor to moderate risk non-cardiac surgery.
Methods: We will include 272 women between 18 and 50 years of age undergoing minor- to moderate-risk noncardiac surgery in this randomized, double-blinded clinical trial. Patients will randomly be assigned to intraoperative management of blood pressure with a SPB of 120±5mmHg (intervention group) or standard of care intraoperative blood pressure management (control group). Our primary outcome will be the incidence of PONV during the early (0-2h) postoperative period between the groups. Nausea will be assessed in 15-min intervals in the PACU for the first two postoperative hours on a 100mm visual analog scale. A PONV episode will be defined as the occurrence of nausea (VAS 50mm or greater) or vomiting.
Statistics: The primary outcome, the incidence of PONV during the early (0-2 hours) postoperative period will be compared between the intervention and control group using a Chi- Square-Test.
Level of originality: Data regarding the effects of intraoperative blood pressure on PONV are very limited and mainly available from retrospective analysis. So far, the effects of blood pressure variability on PONV have not been investigated yet. As PONV is still one of the most common complications after general anaesthesia leading to delayed discharge from PACU, patient discomfort and increased medical costs, it is important to search for additional methods to manage PONV. Our patient population, being at increased risk of PONV, could therefore profit from a more rapid postoperative recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Minimizing blood pressure variabilityIntraoperative blood pressure management will be performed to maintain a systolic blood pressure of 120 ±5mmHg using a continuous infusion of a vasopressor starting at induction of anesthesia. |
| Standard of Care Group | No intervention | –Intraoperative blood pressure management will be performed according to local clinical standard of care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women 18-50 years of age at time of surgery
- ASA physical status I and II
- Scheduled for elective minor or moderate risk non-cardiac surgery with expected time of surgery ≥1 hour
Key exclusion criteria (6 listed)
- Patients undergoing emergency surgery
- Scheduled for pheochromocytoma surgery
- Nausea and/or vomiting on the morning before surgery
- Taking anti-emetic drugs
- Pregnancy
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 |
|---|---|---|
| Minimizing blood pressure variabilityIntraoperative blood pressure management will be performed to maintain a systolic blood pressure of 120 ±5mmHg using a continuous infusion of a vasopressor starting at induction of anaesthesia. | Other | Intervention Group |
Primary outcome
PONV
Time frame: First two postoperative hours
Incidence of postoperative nausea and vomiting within the first two postoperative hours.
3 secondary outcomes
Secondary Outcome 1: Late PONV
Time frame: First three postoperative days
Secondary Outcome 2: Modified Aldrete Score
Time frame: First two postoperative hours
Secondary Outcome 3: Ready for Hospital Discharge Scale
Time frame: First three postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No. We will not share any individual participant data
Related trials for PONV
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Christian Reiterer, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimizing blood pressure variability in people with PONV and Blood Pressure, run by Medical University of Vienna at 1 site in Austria.
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 6 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 11 Jul 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 Austria. 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 Katharina Horvath, MD (0043 1 40400 ext. 20760, katharina.horvath@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PONV (time frame: First two postoperative 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 11 Jul 2023.