Lidocaine Versus Fentanyl for Hemodynamic Stability

NCT06557473 | Completed Phase 4 DMC

• 1 other identifier: PT (812)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Fentanyl; Lidocaine

Keywords

Hypertension; Postinduction hypotension; Lidocaine; Fentanyl

Outcome Measures

Primary Outcomes (1)

• MAP

  Mean Arterial blood pressure 1 minute after induction of anesthesia.

  1 minute after GA induction

Secondary Outcomes (1)

• Number of hypotensive episodes

  20 minutes

Study Arms (2)

The lidocaine group

ACTIVE COMPARATOR

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

Drug: Lidocaine IV

The fentanyl group

PLACEBO COMPARATOR

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

Drug: Fentanyl

Interventions

Lidocaine IV DRUG

1.5mg/kg IV for induction of GA

The lidocaine group

Fentanyl DRUG

Fentanyl IV 2 µg/kg for GA induction

The fentanyl group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, Egypt

Location

Related Publications (3)

• 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.

  PMID: 30235430 BACKGROUND

• 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.

  PMID: 35508291 BACKGROUND

• 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.

  PMID: 33418429 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An investigator not participating in the study was responsible for drug preparation and allocation according the computer generated random numbers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: comparison of lidocaine and fentanyl in hemodynamic stability after induction of general anesthesia in hypertensive patients.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: April 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)