Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting (SICK)

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; PONV; Postoperative Recovery
• Intervention / Treatment: Other: Minimizing blood pressure variability

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 Type: Interventional
• Enrollment (Estimated): 272
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katharina Horvath, MD; Phone Number: 20760 0043 1 40400; Email: katharina.horvath@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Christian Reiterer, MD; Phone Number: 20760 0043 1 40400; Email: christian.reiterer@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Other: Minimizing blood pressure variability; 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.
No Intervention: Standard of Care Group; Intraoperative blood pressure management will be performed according to local clinical standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV	Incidence of postoperative nausea and vomiting within the first two postoperative hours.	First two postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome 1: Late PONV	Incidence of postoperative nausea and vomiting within the first three postoperative days	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.	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.	First three postoperative days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Outcome 1: Intraoperative cerebral oxygen saturation between study groups	Intraoperative non-invasive near-infrared spectroscopy for measurement of cerebral oxygenation.	Throughout surgery
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
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
Substudy 1: Preoperative Copeptin	Comparison between preoperative Copeptin concentrations between patients with and without PONV.	Before surgery

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Christian Reiterer, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Minor- to moderate-risk noncardiac surgery; Blood Pressure Variability
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: SICK_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share any individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No