Comparing drug infusions during laparoscopic gallbladder surgery
Comparative Study Between the Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy
This study is testing which of three different drug infusions—dexmedetomidine, propofol, or lidocaine—works best to keep adults stable during laparoscopic gallbladder surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shibīn Al Kawm, Menoufia) |
| Trial ID | NCT05937282 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of dexmedetomidine, propofol, and lidocaine infusions in managing hemodynamic responses during laparoscopic cholecystectomy. The approach involves monitoring patients' hemodynamic stability using electrical cardiometry while administering these drugs. The goal is to determine which infusion best mitigates the sympathetic response associated with pneumoperitoneum in adult patients. This is a Phase 4 interventional study focusing on adult patients aged 20 to 60 years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 60 years with an American Society of Anesthesiologists classification of I.
Not a fit: Patients with conditions such as diabetes, hypertension, impaired liver or renal function, or those who are morbidly obese may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hemodynamic stability during laparoscopic surgeries, enhancing patient safety and recovery.
How similar studies have performed: Other studies have explored similar drug infusions for hemodynamic control, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shibīn Al Kawm, Menoufia
- Menoufia University — Shibīn Al Kawm, Menoufia, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed M Nassar, MSc
- Email: ahmednasar35@gmail.com
- Phone: +20 122 682 5175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.