Clinical trial NCT06557473: Lidocaine Versus Fentanyl for Hemodynamic Stability
Official title: Hemodynamic Stability of Fentanyl Based Versus Lidocaine Based Induction of Anesthesia in Hypertensive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Fentanyl
Lidocaine
Keywords: Hypertension
Postinduction hypotension
Lidocaine
Fentanyl
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparison of lidocaine and fentanyl in hemodynamic stability after induction of general anesthesia in hypertensive patients.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MAP
timeFrame: 1 minute after GA induction
Secondary outcomes:
measure: Number of hypotensive episodes
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
References:
citation: Yancey R. Anesthetic Management of the Hypertensive Patient: Part II. Anesth Prog. 2018 Fall;65(3):206-213. doi: 10.2344/anpr-65-03-17.
citation: Aissaoui Y, Jozwiak M, Bahi M, Belhadj A, Alaoui H, Qamous Y, Serghini I, Seddiki R. Prediction of post-induction hypotension by point-of-care echocardiography: A prospective observational study. Anaesth Crit Care Pain Med. 2022 Aug;41(4):101090. doi: 10.1016/j.accpm.2022.101090. Epub 2022 May 1.
citation: Hu AM, Qiu Y, Zhang P, Zhao R, Li ST, Zhang YX, Zheng ZH, Hu BL, Yang YL, Zhang ZJ. Higher versus lower mean arterial pressure target management in older patients having non-cardiothoracic surgery: A prospective randomized controlled trial. J Clin Anesth. 2021 May;69:110150. doi: 10.1016/j.jclinane.2020.110150. Epub 2021 Jan 6.