Lidocaine Versus Fentanyl for Hemodynamic Stability

NCT ID: NCT06557473

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-07-01

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.

Conditions

Hypertension; Fentanyl; Lidocaine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

The lidocaine group

Anesthesia will be induced using 1.5 mg/kg lidocaine in the lidocaine group (L), 2mg/kg propofol, and 0.5 mg atracurium.

Group Type: ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type: DRUG

1.5mg/kg IV for induction of GA

The fentanyl group

Anesthesia will be induced using 2 µg/kg fentanyl in the fentanyl group (F), 2mg/kg propofol, and 0.5 mg atracurium.

Group Type: PLACEBO_COMPARATOR

Fentanyl

Intervention Type: DRUG

Fentanyl IV 2 µg/kg for GA induction

Interventions

Lidocaine IV

1.5mg/kg IV for induction of GA

Intervention Type: DRUG

Fentanyl

Fentanyl IV 2 µg/kg for GA induction

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Moshira sayed mohamed

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Theodor Bilharz Research Institute

Giza, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 30235430 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35508291 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33418429 (View on PubMed)

Other Identifiers

PT (812)

Identifier Type: -

Identifier Source: org_study_id