Blood Pressure Clinical Trial
— SICKOfficial 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.
Status | Recruiting |
Enrollment | 272 |
Est. completion date | February 1, 2026 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Outcome 1: Intraoperative cerebral oxygen saturation between study groups | Intraoperative non-invasive near-infrared spectroscopy for measurement of cerebral oxygenation. | Throughout surgery | |
Other | Exploratory Outcome 2: Intraoperative cerebral oxygen saturation between patients, who experienced PONV, and patients without PONV | Intraoperative non-invasive near-infrared spectroscopy for measurement of cerebral oxygenation. | Throughout surgery and first two postoperative hours | |
Other | Exploratory Outcome 3: Impact of Event Scale-Revised | A self-report measure to evaluate the presence of posttraumatic stress disorder. It consists of 22 items, which are rated on a 4-point scale ranging from 0 ("not at all") to 4 ("extremely"). Values are added up for the avoidance subscale, the intrusion subscale and the hyperarousal subcale and X is calculated via the following formula: X = (-0,02 x Intrusion) + (0,07 x Avoidance) + (0,15 x Hyperarousal) - 4,36. A value for X > 0 indicates the likely presence of PTSD. | Before surgery | |
Other | Substudy 1: Preoperative Copeptin | Comparison between preoperative Copeptin concentrations between patients with and without PONV. | Before surgery | |
Primary | PONV | Incidence of postoperative nausea and vomiting within the first two postoperative hours. | First two postoperative hours | |
Secondary | Secondary Outcome 1: Late PONV | Incidence of postoperative nausea and vomiting within the first three postoperative days | First three postoperative days | |
Secondary | 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. | First two postoperative hours | |
Secondary | 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. | First three postoperative days |
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