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NCT06557473CompletedPhase 4

Lidocaine Versus Fentanyl for Hemodynamic Stability

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

Source: ClinicalTrials.gov · Last updated 23 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
40 (actual)
First submitted
13 Aug 2024
Start date
1 Apr 2023
Primary completion date
1 May 2024
Lead sponsor
Theodor Bilharz Research Institute
NCT number
NCT06557473

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 40
  • From 1 Apr 2023 to the primary completion date, 1 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Uncontrolled hypertension (SPB \> 140 mm Hg) OR (DBP \< 90 mm HG).
  • SVV (stroke volume variability) ≥ 13.
  • History of drug abuse.
  • Allergy to any of the used medications.

Other

  • 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.
  • Obese patients (BMI ≥ 35kg/m2).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Theodor Bilharz Research Institute
Coordinator of this site? Confirm its status
GizaEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.