Remifentanil and Stress Hormones Response

Not Applicable

Completed

• Conditions: Stress Response
• Interventions: Drug: Remifentanil Injectable Product

• Registration Number: NCT03378674
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Remifentanil Injectable Product	remifentanil infusion of 0,3 mcg/Kg/min
Group A	Remifentanil Injectable Product	remifentanil infusion of 0,15 mcg/Kg/min

Primary Outcome Measures

Name	Time	Method
Growth hormone levels changes	changes between basal, incision,one hour after surgery
prolactin levels changes	changes between basal, incision,one hour after surgery
ACTH levels changes	changes between basal, incision,one hour after surgery
Cortisol levels changes	changes between basal, incision,one hour after surgery

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy