Comparative Study Between the Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy
| Registry | NCT05937282 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Menoufia University (Other) |
| Conditions | Hemodynamic Responses, Laparoscopic Cholecystectomy, Dexmedetomidine, Lidocaine, Propofol |
| Interventions | Dexmedetomidine, Propofol, Lidocain, normal saline (Drug) |
| Dates | start 2023-07-01, primary completion 2023-10-30 (estimated), completion 2023-10-30 (estimated), first posted 2023-07-10, last updated 2023-07-11 |
| Locations | 1 site in Egypt |
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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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control group | Placebo comparator | Drug: normal saline | Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump. |
| Dexmedetomidine group | Active comparator | 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 | Active comparator | Drug: 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 |
| Lidocaine | Active comparator | Drug: 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. |
Sex: All, ages: 20 Years to 60 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Menoufia University | Shibīn al Kawm, Menoufia | Egypt | Recruiting |