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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05937282
Other study ID # 2/2020ANET27
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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