Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy

Cairo University (CU)

Status and phase: Enrolling; Phase 4

Conditions: Post-induction Hypotension; Lidocaine; Emergency Laparotomy; Opioid

Treatments: Drug: Succinyl choline; Drug: Lidocaine; Drug: Propofol; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06772727

MD-265-2024

Details and patient eligibility

About

The primary role of anesthesia is to provide unconsciousness, amnesia, immobility, and pain control. Other important roles include maintaining stable vital signs and tissue perfusion, preventing and management of organ failure.

Emergency laparotomy represents a major surgical procedure which is usually performed in patients with acute and chronic comorbidities and is associated with several surgical and medical complications with post-induction hypotension being one of the common and serious complication. Thus, it is essential to provide a balanced and safe protocol for anesthesia which maintains adequate hypnosis and antinociception besides vital stability and adequate perfusion.

Opioid drugs are commonly used within the context of balanced general anesthesia primarily for their antinociceptive effects. Opioid drugs had been a basic component of perioperative care for providing analgesia and decreasing the requirements of other hypnotic drugs. However, there are several short- and long-term adverse effects for opioid drugs such as pruritus, postoperative nausea and vomiting, respiratory depression, dependence, and development of chronic pain. Furthermore, opioid drugs are claimed to have cardiovascular depressant effects which increases the risk of hypotension if they were used routinely in patients with borderline hemodynamic profile. Therefore, there is an increased interest in opioid-sparing and opioid-free anesthesia and several international consensus statements were released to regulate and suggest protocols for opioid-sparing anesthetic regimens.

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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. Hypertensive patients and patients on beta blockers.
9. Uncontrolled hypertensive patients or patients receiving angiotensin converting enzyme (ACE) inhibitors preoperatively.
10. Opioid drug abusers.
11. Patients with increased intracranial tension.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Lidocaine group

Active Comparator group

Description:

Patients will receive 1 mg/kg lidocaine intravenously (IV)

Treatment:

Drug: Succinyl choline

Drug: Propofol

Drug: Lidocaine

Fentanyl group

Active Comparator group

Description:

Patients will receive 1 mcg/kg fentanyl intravenously (IV)

Treatment:

Drug: Succinyl choline

Drug: Propofol

Drug: Fentanyl