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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Laparoscopic Cholecystectomy; Propofol; Lidocaine; Hemodynamic Responses
• Intervention / Treatment: Drug: normal saline; Drug: Dexmedetomidine; Drug: Propofol; Drug: Lidocain

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed M Nassar, MSc; Phone Number: +20 122 682 5175; Email: ahmednasar35@gmail.com

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt
      • Recruiting
      • Menoufia University
      • Contact: Ahmed M Nassar; Phone Number: +20 122 682 5175; Email: ahmednasar35@gmail.com
      • Principal Investigator: Ghada A Hassan, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump.	Drug: normal saline; Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).
Active Comparator: Dexmedetomidine group; 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.	Drug: 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.
Active Comparator: 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	Drug: 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.
Active Comparator: Lidocaine; 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninvasive mean blood pressure	mean blood pressure will be noted by a standard automated multi channel monitor will be connected to each patient	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative rescue drugs	Patients that will need rescue drugs (fentanyl) will be recorded with the total dose used.	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)	24 hour postoperatively

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Dexmedetomidine; Lidocaine
• Other Study ID Numbers: 2/2020ANET27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author from one year after study completion
• IPD Sharing Time Frame: from one year after study completion
• IPD Sharing Access Criteria: The data will be available upon reasonable request from the corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes