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

Phase 4

Recruiting

• Conditions: Lidocaine; Propofol; Hemodynamic Responses; Laparoscopic Cholecystectomy; Dexmedetomidine
• Interventions: Drug: normal saline; Drug: Lidocain; Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT05937282
• Lead Sponsor: Menoufia University

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2023-06-18
• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-09
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-11
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	normal saline	Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump.
Lidocaine	Lidocain	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.
Dexmedetomidine group	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.
Propofol	Propofol	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

Primary Outcome Measures

Name	Time	Method
Noninvasive mean blood pressure	Intraoperatively	mean blood pressure will be noted by a standard automated multi channel monitor will be connected to each patient

Secondary Outcome Measures

Name	Time	Method
Intraoperative rescue drugs	Intraoperatively	Patients that will need rescue drugs (fentanyl) will be recorded with the total dose used.
Post extubation sedation	24 hour postoperatively	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)

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt