Lidocaine Versus Fentanyl for Hemodynamic Stability

Phase 4

Completed

• Conditions: Hypertension; Fentanyl; Lidocaine
• Interventions: Drug: Lidocaine IV; Drug: Fentanyl

• Registration Number: NCT06557473
• Lead Sponsor: Theodor Bilharz Research Institute

Brief Summary

Hypertension is an important health challenge that affects millions of people across the world today and is a major risk factor for multiple system comorbidities. Intraoperative hypotension may lead to negative outcomes. 'Post-induction hypotension' (PIH; i.e. arterial hypotension defined as hypotension during the first 20 min after anesthesia induction, or from anesthesia induction until the beginning of surgery) and 'early intraoperative hypotension' (eIOH; i.e. arterial hypotension occurring during the first 30 min of surgery). Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.

Detailed Description

Since post induction hypotension is mainly caused by anesthetic drugs, developing a technique for the induction of anesthesia that provides adequate hypnosis with stable hemodynamics during surgery is critical, especially for hypertensive patients. (4) Propofol is the most commonly used drug for anesthesia induction; however, its use is usually associated with hypotension through vasodilation and direct myocardial depression. (5) Opioid drugs are usually added to propofol to potentiate its hypnotic effect; however, they also potentiate propofol's negative hemodynamic effect at the same degree, even with low doses of propofol (5).

Lidocaine is a local anesthetic drug with multiple systemic uses. Systemic lidocaine used as at the perioperative period has analgesic, and anti-inflammatory properties which make it capable of reducing intra- and postoperative drug consumptions and patients' hospital stay. (6) Lidocaine/ketamine combination showed a favorable hemodynamic profile following rapid-sequence induction of anesthesia in septic shock patients \[14\]. Therefore, we hypothesize that the use of lidocaine as an adjuvant to propofol might reduce the risk of post induction hypotension and hence having more stable hemodynamic profile during induction of anesthesia.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-07-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. ASA II, Hypertensive patients with the following criteria:

   • Diagnosed with hypertension more than 5 years and on continuous medications.
   • Controlled hypertension (systolic pressure < 140 mm Hg and the diastolic < 90 mm Hg).

2. Age: 18-60 years of both sexes.

3. Elective non cardiac surgery requiring general anesthesia.

Exclusion Criteria

1. Uncontrolled hypertension (SPB > 140 mm Hg) OR (DBP < 90 mm HG).
2. SVV (stroke volume variability) ≥ 13.
3. Patients with suspected difficult intubation as judged by the attending anesthetist during the preoperative assessment and patients for whom an alternative device other than an endotracheal tube will be considered.
4. Pregnancy.
5. History of drug abuse.
6. Obese patients (BMI ≥ 35kg/m2).
7. Allergy to any of the used medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The lidocaine group	Lidocaine IV	Anesthesia will be induced using 1.5 mg/kg lidocaine in the lidocaine group (L), 2mg/kg propofol, and 0.5 mg atracurium.
The fentanyl group	Fentanyl	Anesthesia will be induced using 2 µg/kg fentanyl in the fentanyl group (F), 2mg/kg propofol, and 0.5 mg atracurium.

Primary Outcome Measures

Name	Time	Method
MAP	1 minute after GA induction	Mean Arterial blood pressure 1 minute after induction of anesthesia.

Secondary Outcome Measures

Name	Time	Method
Number of hypotensive episodes	20 minutes	MAP less than 65 mmHg.

Trial Locations

Locations (1)

Theodor Bilharz Research Institute; 🇪🇬 Giza, Egypt