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

NCT05937282 — Phase 4, Unknown, 80 participants, Menoufia University

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

RegistryNCT05937282
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment80 (Estimated)
SponsorMenoufia University (Other)
ConditionsHemodynamic Responses, Laparoscopic Cholecystectomy, Dexmedetomidine, Lidocaine, Propofol
InterventionsDexmedetomidine, Propofol, Lidocain, normal saline (Drug)
Datesstart 2023-07-01, primary completion 2023-10-30 (estimated), completion 2023-10-30 (estimated), first posted 2023-07-10, last updated 2023-07-11
Locations1 site in Egypt

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-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.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
Control groupPlacebo comparatorDrug: normal salinePatients will receive infusion of 25 ml normal saline in 50 ml syringe pump.
Dexmedetomidine groupActive comparatorDrug: DexmedetomidinePatients 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.
PropofolActive comparatorDrug: PropofolPatients 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
LidocaineActive comparatorDrug: LidocainPatients 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.
  • Dexmedetomidine (Drug): 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 (Drug): 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 (Drug): 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 (Drug): Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).

+Outcome measures

Primary outcomes

  • Noninvasive mean blood pressure [Intraoperatively]: mean blood pressure will be noted by a standard automated multi channel monitor will be connected to each patient

Secondary outcomes

  • Intraoperative rescue drugs [Intraoperatively]: Patients that will need rescue drugs (fentanyl) will be recorded with the total dose used.
  • Post extubation sedation [24 hour postoperatively]: 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)

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Menoufia UniversityShibīn al Kawm, MenoufiaEgyptRecruiting

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