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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-induction Hypotension Lidocaine Opioid Emergency Laparotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lidocaine group

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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)

Propofol

Intervention Type DRUG

After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously

Succinyl choline

Intervention Type DRUG

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.

Fentanyl group

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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).

Propofol

Intervention Type DRUG

After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously

Succinyl choline

Intervention Type DRUG

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.

Interventions

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Lidocaine

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)

Intervention Type DRUG

Fentanyl

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).

Intervention Type DRUG

Propofol

After administration of the study drug, all patients will receive 2 mg/kg propofol intravenously

Intervention Type DRUG

Succinyl 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No