Postinduction Hypotension
Conditions
Keywords
major abdominal surgery, high risk patients, ephedrine, prophylaxis, postinduction hypotension
Brief summary
The aim of this work is to assess the efficacy of intermittent ephedrine boluses in prophylaxis against postinduction hypotension in high-risk patients undergoing major abdominal surgery, compared to standard care.
Detailed description
Fluid responders (≥20% rise in perfusion index on passive leg raising) will receive 500-mL Ringer's boluses (up to 1500 mL). Anesthesia will be induced with fentanyl/propofol, intubated after neuromuscular blockade, and maintained with isoflurane (1.2% end-tidal). Study drug will be given at induction and every 5 minutes for 20 minutes, withheld if MAP ≥80 mmHg or a recent vasopressor dose. Hypotension (MAP \<65 mmHg) will be treated with 0.1 mg/kg ephedrine boluses (max 9 mg single). Post-incision care follows anesthetist discretion.
Interventions
DRUGNormal Saline
four 10-mL syringes of normal saline, The patient will receive the first dose of the intervention with induction (0.1 ml/kg). After induction of anesthesia, the study drug will be given every 5 min for 20 min and will be withheld if MAP was ≥80 mmHg or if any vasopressor is given within 2 min of the current scheduled dose
DRUGEphedrine
four 10-mL syringes of ephedrine 1 mg/mL. The patient will receive the first dose of the intervention with induction (0.1 ml/kg). After induction of anesthesia, the study drug will be given every 5 min for 20 min and will be withheld if MAP was ≥80 mmHg or if any vasopressor is given within 2 min of the current scheduled dose.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged \>50 years, * weight \>50 kg, * American Society of Anesthesiologists (ASA) Physical Status score of \> I, * undergoing major abdominal surgery
Exclusion criteria
* Severe cardiac morbidities (impaired contractility with ejection fraction \< 40%, heart block, significant uncontrolled arrhythmias, tight stenotic valvular lesions) * Acute cardiovascular pathologies: acute/decompensated heart failure, acute coronary syndrome * Uncontrolled hypertension (systolic blood pressure\>150 mmHg) * Preoperative HR more than 110 bpm despite proper fluid management and patients with renal impairment * Renal impairment * Patients on vasopressor infusion, * Allergy of any of the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postinduction hypotension | from induction of anesthesia until 20 minutes after induction | mean arterial pressure \< 65 mmHg |
Secondary
| Measure | Time frame |
|---|---|
| area under mean arterial pressure of 65 mmHg | from induction of anesthesia until 20 minutes after induction |
Countries
Egypt
Contacts
CONTACTMaha Mostafa, MD
Outcome results
None listed