Clinical trial NCT05596695: Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting
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
Overall status: RECRUITING
Phase: NA
Conditions: PONV
Blood Pressure
Postoperative Recovery
Keywords: Blood Pressure Variability
Minor- to moderate-risk noncardiac surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 272
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: PONV
timeFrame: First two postoperative hours
Secondary outcomes:
measure: Secondary Outcome 1: Late PONV
timeFrame: First three postoperative days
measure: Secondary Outcome 2: Modified Aldrete Score
timeFrame: First two postoperative hours
measure: Secondary Outcome 3: Ready for Hospital Discharge Scale
timeFrame: First three postoperative days
Other outcomes:
measure: Exploratory Outcome 1: Intraoperative cerebral oxygen saturation between study groups
timeFrame: Throughout surgery
measure: Exploratory Outcome 2: Intraoperative cerebral oxygen saturation between patients, who experienced PONV, and patients without PONV
timeFrame: Throughout surgery and first two postoperative hours
measure: Exploratory Outcome 3: Impact of Event Scale-Revised
timeFrame: Before surgery
measure: Substudy 1: Preoperative Copeptin
timeFrame: Before surgery
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Christian Reiterer, MD
role: PRINCIPAL_INVESTIGATOR
References: