Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting (SICK)
Primary Purpose
PONV, Blood Pressure, Postoperative Recovery
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Minimizing blood pressure variability
Sponsored by
About this trial
This is an interventional prevention trial for PONV focused on measuring Blood Pressure Variability, Minor- to moderate-risk noncardiac surgery
Eligibility Criteria
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
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Standard of Care Group
Arm Description
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.
Intraoperative blood pressure management will be performed according to local clinical standard of care.
Outcomes
Primary Outcome Measures
PONV
Incidence of postoperative nausea and vomiting within the first two postoperative hours.
Secondary Outcome Measures
Secondary Outcome 1: Late PONV
Incidence of postoperative nausea and vomiting within the 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.
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.
Full Information
NCT ID
NCT05596695
First Posted
October 24, 2022
Last Updated
July 7, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05596695
Brief Title
Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting
Acronym
SICK
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PONV, Blood Pressure, Postoperative Recovery
Keywords
Blood Pressure Variability, Minor- to moderate-risk noncardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
272 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Intraoperative blood pressure management will be performed according to local clinical standard of care.
Intervention Type
Other
Intervention Name(s)
Minimizing blood pressure variability
Intervention Description
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.
Primary Outcome Measure Information:
Title
PONV
Description
Incidence of postoperative nausea and vomiting within the first two postoperative hours.
Time Frame
First two postoperative hours
Secondary Outcome Measure Information:
Title
Secondary Outcome 1: Late PONV
Description
Incidence of postoperative nausea and vomiting within the first three postoperative days
Time Frame
First three postoperative days
Title
Secondary Outcome 2: Modified Aldrete Score
Description
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.
Time Frame
First two postoperative hours
Title
Secondary Outcome 3: Ready for Hospital Discharge Scale
Description
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.
Time Frame
First three postoperative days
Other Pre-specified Outcome Measures:
Title
Exploratory Outcome 1: Intraoperative cerebral oxygen saturation between study groups
Description
Intraoperative non-invasive near-infrared spectroscopy for measurement of cerebral oxygenation.
Time Frame
Throughout surgery
Title
Exploratory Outcome 2: Intraoperative cerebral oxygen saturation between patients, who experienced PONV, and patients without PONV
Description
Intraoperative non-invasive near-infrared spectroscopy for measurement of cerebral oxygenation.
Time Frame
Throughout surgery and first two postoperative hours
Title
Exploratory Outcome 3: Impact of Event Scale-Revised
Description
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.
Time Frame
Before surgery
Title
Substudy 1: Preoperative Copeptin
Description
Comparison between preoperative Copeptin concentrations between patients with and without PONV.
Time Frame
Before surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Horvath, MD
Phone
0043 1 40400
Ext
20760
Email
katharina.horvath@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Reiterer, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Reiterer, MD
Phone
0043 1 40400
Ext
20760
Email
christian.reiterer@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not share any individual participant data
Learn more about this trial
Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting
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