Remifentanil and Stress Hormones Response

NCT ID: NCT03378674

Last Updated: 2018-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-07-31

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.

Conditions

Stress Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group A

remifentanil infusion of 0,15 mcg/Kg/min

Group Type: EXPERIMENTAL

Remifentanil Injectable Product

Intervention Type: DRUG

remifentanil: 0,15 mcg/kg/min

Group B

remifentanil infusion of 0,3 mcg/Kg/min

Group Type: ACTIVE_COMPARATOR

Remifentanil Injectable Product

Intervention Type: DRUG

remifentanil: 0,15 mcg/kg/min

Interventions

Remifentanil Injectable Product

remifentanil: 0,15 mcg/kg/min

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Germano De Cosmo

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flaminio Sessa, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University Rome

Locations

Catholic University of Sacred Heart

Rome, , Italy

Countries

Italy

References

Jakeways MS, Mitchell V, Hashim IA, Chadwick SJ, Shenkin A, Green CJ, Carli F. Metabolic and inflammatory responses after open or laparoscopic cholecystectomy. Br J Surg. 1994 Jan;81(1):127-31. doi: 10.1002/bjs.1800810146.

Reference Type: BACKGROUND

PMID: 8313088 (View on PubMed)

Marana E, Scambia G, Maussier ML, Parpaglioni R, Ferrandina G, Meo F, Sciarra M, Marana R. Neuroendocrine stress response in patients undergoing benign ovarian cyst surgery by laparoscopy, minilaparotomy, and laparotomy. J Am Assoc Gynecol Laparosc. 2003 May;10(2):159-65. doi: 10.1016/s1074-3804(05)60291-5.

Reference Type: BACKGROUND

PMID: 12732764 (View on PubMed)

Adas G, Kemik A, Adas M, Koc B, Gurbuz E, Akcakaya A, Karahan S. Metabolic and inflammatory responses after ERCP. Int J Biomed Sci. 2013 Dec;9(4):237-42.

Reference Type: BACKGROUND

PMID: 24711760 (View on PubMed)

Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.

Reference Type: BACKGROUND

PMID: 10927999 (View on PubMed)

Other Identifiers

CUSacredHeart

Identifier Type: -

Identifier Source: org_study_id