Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy

Menoufia University80 enrolled

Overview

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.

Many drug infusions have been used to control hemodynamic responses to laparoscopic surgeries like propofol, fentanyl, esmolol with varying degrees of success. Dexmedetomidine has sedative and analgesic properties seems to be appropriate enough to control the sympathetic response as well as provide a stable hemodynamics

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hemodynamic Responses Laparoscopic Cholecystectomy Dexmedetomidine Lidocaine Propofol

Interventions

DexmedetomidineDRUG

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.

PropofolDRUG

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.

LidocainDRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Menoufia University

Shibīn al Kawm, Menoufia, Egypt

RECRUITING

Outcomes

Primary Outcomes

Noninvasive mean blood pressure

mean blood pressure will be noted by a standard automated multi channel monitor will be connected to each patient

Time frame: Intraoperatively

Secondary Outcomes

Intraoperative rescue drugs

Patients that will need rescue drugs (fentanyl) will be recorded with the total dose used.

Time frame: Intraoperatively

Post extubation sedation

Post extubation sedation assessment will be done in each group using Ramsey's sedation score. Anxious, agitated or restless = (1) Cooperative, oriented and tranquil = (2) Responsive to command only = (3) Brisk response to light glabellar tap or loud auditory stimulus = (4) Sluggish response to light glabellar tap or loud auditory stimulus = (5) No response = (6)

Time frame: 24 hour postoperatively

Central Contacts

Ahmed M Nassar, MSc

CONTACT

+20 122 682 5175 ahmednasar35@gmail.com

Data from ClinicalTrials.gov

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