Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting

NCT05596695 | Unknown DMC

• 1 other identifier: SICK_01
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

PONV; Blood Pressure; Postoperative Recovery

Keywords

Blood Pressure Variability; Minor- to moderate-risk noncardiac surgery

Outcome Measures

Primary Outcomes (1)

• PONV

  Incidence of postoperative nausea and vomiting within the first two postoperative hours.

  First two postoperative hours

Secondary Outcomes (3)

• Secondary Outcome 1: Late PONV

  First three postoperative days

• Secondary Outcome 2: Modified Aldrete Score

  First two postoperative hours

• Secondary Outcome 3: Ready for Hospital Discharge Scale

  First three postoperative days

Other Outcomes (4)

• Exploratory Outcome 1: Intraoperative cerebral oxygen saturation between study groups

  Throughout surgery

• Exploratory Outcome 2: Intraoperative cerebral oxygen saturation between patients, who experienced PONV, and patients without PONV

  Throughout surgery and first two postoperative hours

• Exploratory Outcome 3: Impact of Event Scale-Revised

  Before surgery

Study Arms (2)

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.

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.

Interventions

Minimizing blood pressure variability OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Christian Reiterer, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Horvath, MD

CONTACT

0043 1 40400; katharina.horvath@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)