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

Phase 4

Recruiting

• Conditions: Post-induction Hypotension; Lidocaine; Opioid; Emergency Laparotomy
• Interventions: Drug: Lidocaine; Drug: Fentanyl; Drug: Propofol; Drug: Succinyl choline

• Registration Number: NCT06772727
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-13
• Study Start: 2025-01-15
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Lidocaine	Patients will receive 1 mg/kg lidocaine intravenously (IV)
Lidocaine group	Propofol	Patients will receive 1 mg/kg lidocaine intravenously (IV)
Lidocaine group	Succinyl choline	Patients will receive 1 mg/kg lidocaine intravenously (IV)
Fentanyl group	Fentanyl	Patients will receive 1 mcg/kg fentanyl intravenously (IV)
Fentanyl group	Propofol	Patients will receive 1 mcg/kg fentanyl intravenously (IV)
Fentanyl group	Succinyl choline	Patients will receive 1 mcg/kg fentanyl intravenously (IV)

Primary Outcome Measures

Name	Time	Method
Hypotension	immediately after induction of anesthesia until 20 minutes after induction of anesthesia	Incidence of post-induction hypotension

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Egypt