None listed
Conditions
Brief summary
The goal of this study is to determine if (H1) dexmedetomidine and midazolam are equally effective in reducing anxiety and stress response of surgical patients for elective cholecystectomy. 60 patients aged between 18 and 70, of ASA status I and II and BMI between 18 and 30 will be randomly allocated into dexmedetomidine and midazolam premedication group. Primary outcome will be a comparison of plasma ACTH level. Secondary outcomes will be a comparison of perioperative hemodynamic data, neutrphil/lymphocyte ratio, NPRS scores, and amount of drugs (opioids, induction agents, ephedrine) used.
Interventions
Intervention undertaken will be one application of 0.3 mcg/kg of dexmedetomidine in 100 mL of saline infused over 20 minutes (Subject group) as a premedication for patients undergoing elective laparoscopic cholecystectomy. Premedication will be applied by attending anaesthesiologists in a University Hospital Centre PACU. Adherence to intervention will be monitored using study data collection chart.
Sponsors
Department of Anestesiology, Intesive Care Medicine and Pain Managment of the Clinical Hospital Center of "Sister of Mercy" Zagreb
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria are: patients undergoing elective laparoscopic cholecystectomy, age (18-70 years) and ASA Physical status Classification I or II
Exclusion criteria
Body mass index <18 or > 30, Allergy to any of the drugs used, prolonged QT interval, patients with psychiatric diagnoses, patients taking medication that may interfere with ACTH levels (corticosteroids, androgens and estrogens)
Outcome results
None listed