Clinical trial

Comparative Study Between the Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy

Name

2/2020ANET27

Description

This study will be carried out to compare the efficacy of dexmedetomidine, propofol or lidocaine infusions in attenuation of hemodynamic responses to pneumoperitoneum during adult laparoscopic cholecystectomy using electrical cardiometry.

Trial arms

Trial start

2023-07-01

Estimated PCD

2023-10-30

Trial end

2023-10-30

Status

Recruiting

Phase

Early phase I

Treatment

Dexmedetomidine

Patients will receive infusion of dexmedetomidine in the dose of 0.4 μg/kg/hr. One ml dexmedetomidine (100 μg/ml) will be diluted with 24 ml normal saline in 50 ml syringe pump to achieve dilution of 4 μg/ml.

Arms:

Dexmedetomidine group

Propofol

Patients will receive propofol infusion in the dose of 3 mg/kg/hr. 25 ml propofol 1% (10 mg /ml) in 50 ml syringe pump.

Arms:

Propofol

Lidocain

Patients will receive lidocaine infusion in the dose of 2 mg /kg/hr.25 ml lidocaine 1% (10 mg/ml) in 50 ml syringe pump.

Arms:

Lidocaine

normal saline

Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).

Arms:

Control group

Size

Primary endpoint

Noninvasive mean blood pressure

Intraoperatively

Eligibility criteria

Inclusion Criteria: * American Society of Anesthesiologists I patients. * Patients between the ages of ≥ 20 and ≤ 60 years of both sexes. Exclusion Criteria: * Hypersensitivity to dexmedetomidine, propofol or lidocaine. * Diabetic patients (Hemoglobin A1C ≥ 7). * Hypertensive patients (Blood presssure ≥ 140/90 mmHg) or patients on medications that affect hemodynamics as clonidine, methyldopa, β blockers and calcium channel blockers. * Impaired liver function (serum albumin ≤ 3.5 g/dl, International normalized ratio≥ 1.3, total bilirubin \>1mg/dl). * Impaired renal function (serum creatinine \>1.2 mg/dl, blood urea \>20mg/dl). * Morbidly obese patients with body mass index ≥ 40. * Patients with acute cholecystitis or active infection. * Patients taking medications that may impair cognition. * History of seizures.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-07-11

1 organization

3 products

1 drug

5 indications

Organization

Menoufia University

Product

Dexmedetomidine

Indication

Hemodynamic Responses