Hypotension on Induction, Emergency Surgery, Norepinephrine
Conditions
Keywords
hypotension, norepinephrine, emergency surgery
Brief summary
Postinduction hypotension is a frequent intraoperative complication, particularly in emergency abdominal surgery due to factors such as sepsis, hypovolemia, and limited preoperative cardiac assessment. Because it can lead to serious organ injury, prompt prevention and management are essential. Vasopressors, including ephedrine, phenylephrine, and norepinephrine, are commonly used, with NE gaining interest as an intraoperative bolus despite uncertainty about the optimal dose in general surgery population The aim of this study is to compare 5 mcg to 10 mcg norepinephrine bolus for treatment of postinduction hypotension and early intraoperative in emergency abdominal surgery.
Detailed description
fluid assessment using stroke volume change after passive leg raising maneuver will be applied. If stroke volume increase \>10%, 500-mL bolus of lactated ringer will be given. Passive leg raising will be repeated until the patient is non-responder or 1500 mL were infused. intraoperatively, heart rate and blood pressure will be monitored at 2 min intervals until 30 min after skin incision.
Interventions
Norepinephrine dose of 10 mcg will be given if patient developed hypotension (mean arterial pressure \<65 mmHg). The norepinephrine bolus (10 mcg) will be repeated if mean arterial pressure is not restored within 2 min. Norepinephrine infusion will be started if hypotension persisted after three boluses.
Norepinephrine dose of 5 mcg will be given if patient developed hypotension (mean arterial pressure \<65 mmHg). The norepinephrine bolus (5 mcg) will be repeated if mean arterial pressure is not restored within 2 min. Norepinephrine infusion will be started if hypotension persisted after three boluses.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients, American Society of anesthesiologists (ASA) I-III undergoing emergency abdominal surgery
Exclusion criteria
* Severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions) * Patients on vasopressor infusion, * Pregnant or lactating women, * Allergy of any of the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of successfully managed hypotensive episode | from 0 min of induction of anesthesia until 30 min after skin incision | mean arterial pressure \>65 mmHg within 2 min of drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under a mean arterial pressure of 65 mmHg | from 0 min of induction of anesthesia until 30 min after skin incision | The area under a mean arterial pressure (MAP) of 65 mm Hg will be calculated by subtracting MAP measurements from 65 mm Hg, multiplying positive differences with the time difference (in minutes) between this MAP measurement and the consecutive MAP measurement, and summing the values |
| Duration of MAP<65 mmHg | from 0 min after induction of anesthesia until 30 min after skin incision | in minutes |
| bradycardia | from 0 min after induction of anesthesia until 30 min after skin incision | heart rate \< 50 bpm following drug administration |
| hypertension | from 0 min after induction of anesthesia until 30 min after skin incision | systolic blood pressure \>120% of baseline following drug administration |
Countries
Egypt
Contacts
CONTACTMaha Mostafa, MD
Outcome results
None listed