Remifentanil and Stress Hormones Response

Study Overview
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Brief Summary
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Perioperative adequate analgesia reduces neuroendocrine stress response and postoperative complications. Because opioids are the most effective parenteral drugs to control pain and stress response, in this prospective randomized double-blinded controlled study we supposed that higher dose of remifentanil may reduce stress marker variations compared to lower dose in patients undergoing laparoscopic cholecystectomy.

Detailed Description
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Fifty Caucasian patients, aged 20-70 years, with American Society of Anesthesiologist physical status I-II, undergoing laparoscopic cholecystectomy were enrolled. Exclusion criteria were: patient refusal, thyroid disorders, diabetes mellitus, BMI > 30, use of corticosteroids, benzodiazepines or antipsychotics drugs. No patient received premedication. Before entering the operating room, venous access was established (18 G in the antecubital vein) where the first blood sample (Time 0) was collected to measure adrenocorticotropic hormone (ACTH), Cortisol, Growth hormone (GH) and prolactin (PRL) levels. Then a second venous access was established (18 G on the other arm) to start a fluid infusion (normal saline to replace half of the water deficit from preoperative fasting followed by a maintenance infusion of 2 ml/kg/h). Heart Rate (HR), Non Invasive Blood Pressure (NIBP), Bispectral Index (BIS), End-tidal CO2 (EtCO2) were recorded every 5 minutes. Patients were randomly assigned to receive two different dosages of remifentanil: 0,15 mcg/kg/min (group A) and 0,30 mcg/kg/min (group B) for the induction and the maintenance of anesthesia, using a computer generated randomization table (Table I). Anesthesia was induced with propofol 2 mg/kg, cisatracurium 0,15 mg/kg and remifentanil infusion of 0,15 mcg/Kg/min (Group A) or 0,3 mcg/Kg/min (Group B) was started. Anesthesia was maintained with desflurane at a variable concentration in order to maintain the BIS between 40 and 60. The second blood sample was collected at the trocar insertion (Time 1), and the third sample one hour after the end of the surgery (Time 2). Postoperative analgesia was standardized using intravenous acetaminophen 1 g and morphine 0,1 mg/kg 30 minutes before the end of the surgery. Rescue analgesia in Recovery Room was provided by intravenous tramadol 1 mg/Kg.

Official Title
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Effect of Different Doses of Remifentanil on Stress Response During Laparoscopic Cholecystectomy

Conditions
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Stress Response

Intervention / Treatment
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* Drug: Remifentanil Injectable Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist physical status I-II Undergoing laparoscopic cholecystectomy Exclusion Criteria: patient refusal, thyroid disorders, diabetes mellitus, BMI > 30, use of corticosteroids, benzodiazepines or antipsychotics drugs

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>remifentanil infusion of 0,15 mcg/Kg/min | Drug: Remifentanil Injectable Product<br>* remifentanil: 0,15 mcg/kg/min<br>|
| Active Comparator: Group B<br>remifentanil infusion of 0,3 mcg/Kg/min | Drug: Remifentanil Injectable Product<br>* remifentanil: 0,15 mcg/kg/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACTH levels changes |  | changes between basal, incision,one hour after surgery | 
| Cortisol levels changes |  | changes between basal, incision,one hour after surgery | 
| Growth hormone levels changes |  | changes between basal, incision,one hour after surgery | 
| prolactin levels changes |  | changes between basal, incision,one hour after surgery |