Emergency Laparotomy, Lidocaine, Opioid, Post-induction Hypotension
Conditions
Brief summary
Lidocaine-based anesthesia had been recently reported as a successful regimen for induction of anesthesia in elderly population with better hemodynamic profile than opioid-based induction. The investigators hypothesize that lidocaine-based induction of anesthesia would provide superior hemodynamic profile compared to conventional opioid-based induction of anesthesia in emergency laparotomy.
Interventions
DRUGLidocaine
After preoxygenation with 100% oxygen for 3 minutes, the study drug (lidocaine) will be administered. Patients will receive 1 mg/kg lidocaine of 10 mg/mL lidocaine solution (prepared by diluting 5 mL of lidocaine 20% in saline to a total volume of 10 mL)
DRUGFentanyl
After preoxygenation with 100% oxygen for 3 minutes, the study drug (fentanyl) will be administered. Patients will receive 1 mcg/kg fentanyl of 10 mcg/mL fentanyl solution (prepared by diluting 100 mcg fentanyl in saline to a total volume of 10 mL).
DRUGPropofol
After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously
DRUGSuccinyl choline
After loss of consciousness, 1 mg/kg succinyl choline will be administered over 5 seconds, and tracheal intubation will be done through direct laryngoscopy after 60 seconds.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients 2. Both gender 3. American Society of Anesthesiologists (ASA) class I-III undergoing emergency laparotomy.
Exclusion criteria
1. Patient refusal 2. Severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions) 3. Baseline mean arterial pressure \<75 mmHg 4. Patients on vasopressor infusion, 5. Patients with high shock index (heart rate / systolic blood pressure \>1) 6. Pregnant or lactating women, 7. Allergy of any of the study drugs 8. Uncontrolled hypertension 9. Opioid drug abusers 10. Patients with increased intracranial tension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension | immediately after induction of anesthesia until 20 minutes after induction of anesthesia | Incidence of post-induction hypotension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Norepinephrine dose | from induction of anesthesia until 20 minutes after skin incision | Total norepinephrine dose during the period from induction of anesthesia until 20-minutes after intubation or skin incision |
| Heart rate | every 2 minutes for 20 minutes after induction of anesthesia | — |
| Mean Arterial Pressure | every 2 minutes for 20 minutes after induction of anesthesia | — |
Countries
Egypt
Contacts
STUDY_CHAIRJehan Elkholy, M.D.
Cairo University
STUDY_DIRECTOREman F Ali,, M.D.
Cairo University
STUDY_DIRECTORKareem MA Nawwar, M.D.
Cairo University
STUDY_DIRECTORMohsen M Waheeb, M.D.
Cairo University
PRINCIPAL_INVESTIGATORSamar M Abdel Azeim Ghazala, M.Sc.
Cairo University
Outcome results
None listed