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

Menoufia University

Status and phase: Enrolling; Phase 4

Conditions: Hemodynamic Responses; Propofol; Dexmedetomidine; Laparoscopic Cholecystectomy; Lidocaine

Treatments: Drug: Lidocain; Drug: Propofol; Drug: normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05937282

2/2020ANET27

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump.

Treatment:

Drug: normal saline

Dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Propofol

Active Comparator group

Description:

Patients will receive propofol infusion in the dose of 3 mg/kg/hr. (12) 25 ml propofol 1% (10 mg /ml) in 50 ml syringe pump

Treatment:

Drug: Propofol

Lidocaine

Active Comparator group

Description:

Patients will receive lidocaine infusion in the dose of 2 mg /kg/hr. (15) 25 ml lidocaine 1% (10 mg/ml) in 50 ml syringe pump.

Treatment:

Drug: Lidocain