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Completed

NCT Number: NCT06557473

Lidocaine Versus Fentanyl for Hemodynamic Stability

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Theodor Bilharz Research Institute

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Age: 18-60 years of both sexes.
  • Elective non cardiac surgery requiring general anesthesia.

Exclusion criteria

  • Uncontrolled hypertension (SPB > 140 mm Hg) OR (DBP < 90 mm HG).
  • SVV (stroke volume variability) ≥ 13.
  • 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.
  • Pregnancy.
  • History of drug abuse.
  • Obese patients (BMI ≥ 35kg/m2).
  • Allergy to any of the used medications.

Treatment and study plan

Lidocaine IV

Drug

1.5mg/kg IV for induction of GA

Fentanyl

Drug

Fentanyl IV 2 µg/kg for GA induction

Primary outcomes

  1. MAP

    Time frame: 1 minute after GA induction

    Mean Arterial blood pressure 1 minute after induction of anesthesia.

Secondary outcomes

  1. Number of hypotensive episodes

    Time frame: 20 minutes

    MAP less than 65 mmHg.

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Official study title

Hemodynamic Stability of Fentanyl Based Versus Lidocaine Based Induction of Anesthesia in Hypertensive Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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