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

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937282
• Other study ID #: 2/2020ANET27
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: July 2023
• Source: Menoufia University
• Contact: Ahmed M Nassar, MSc
• Phone: +20 122 682 5175
• Email: ahmednasar35[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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, ß 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.

Related Conditions & MeSH terms

• Dexmedetomidine
• Laparoscopic Cholecystectomy
• Lidocaine
• Propofol

Intervention

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

Locations

Country	Name	City	State
Egypt	Menoufia University	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperative rescue drugs	Patients that will need rescue drugs (fentanyl) will be recorded with the total dose used.	Intraoperatively
Secondary	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