None listed
Conditions
Brief summary
This pilot trial will determine whether noradrenaline, a medication commonly used to treat low blood pressure in hospitals, could benefit patients undergoing major surgery. There is new evidence in the literature to suggest that targeting a higher blood pressure during surgery might be associated with improved patient outcomes. The aim of the study is to determine whether a larger definitive trial is worthwhile and feasible. The results from this study will be used to guide the development of a larger study across many hospital sites.
Interventions
Low-dose intravenous continuous noradrenaline infusion (10mcg/ml) in patients undergoing major surgery, titrated to a target systolic BP (120mmHg or within 10% of the patient’s lowest preoperative systolic BP value, whichever is lower) with a maximum rate of 0.1mcg/kg/min. The study drug infusion will commence on induction and continue for up to 4 hours postoperatively for patients going to the ward via PACU, and up to 24 hours postoperatively for patients being admitted to HDU/ICU.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults requiring general anaesthesia for non-cardiac elective surgery, of at least 2 hour duration, and expected hospital stay of at least three days. In addition, patients should be at increased risk of postoperative complications, such as increased age, ASA score 3-4, history of cardiac disease, or extremes of weight.
Exclusion criteria
Patient refusal, preoperative vasopressor or isotrope revirement, videoscopic surgery with an incision less than 10cm, use of monoamine oxidase inhibitors, pregnant or breastfeeding women.
Outcome results
None listed