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CompletedNCT03378674Updated Jan 8, 2018

Remifentanil and Stress Hormones Response

An interventional study of Remifentanil Injectable Product in Stress Response, sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-08.

Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stress Response
03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiologist physical status I-II
  • Undergoing laparoscopic cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • patient refusal,
  • thyroid disorders,
  • diabetes mellitus,
  • BMI > 30,
  • use of corticosteroids, benzodiazepines or antipsychotics drugs
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Group A

    remifentanil infusion of 0,15 mcg/Kg/min

    Drug: Remifentanil Injectable Product

  • Active comparator
    Group B

    remifentanil infusion of 0,3 mcg/Kg/min

    Drug: Remifentanil Injectable Product

Interventions

  • DrugRemifentanil Injectable Product

    remifentanil: 0,15 mcg/kg/min

05

What researchers measure

Primary outcomes

  1. ACTH levels changes

    Time frame: changes between basal, incision,one hour after surgery

  2. Cortisol levels changes

    Time frame: changes between basal, incision,one hour after surgery

  3. Growth hormone levels changes

    Time frame: changes between basal, incision,one hour after surgery

  4. prolactin levels changes

    Time frame: changes between basal, incision,one hour after surgery

06

Study locations

1 site
  • Catholic University of Sacred Heart
    Rome, 00168, Italy
07

References and documents

Publications

  • 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. PubMed 8313088 ↗
  • 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. PubMed 12732764 ↗
  • 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. PubMed 24711760 ↗
  • 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. PubMed 10927999 ↗
08

Registry details

Key details

Study ID
NCT03378674
Lead sponsor
Catholic University of the Sacred Heart
Responsible party
Germano De Cosmo (professor, Catholic University of the Sacred Heart) — Principal investigator
First posted
Dec 20, 2017
Start date
Jan 2008
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Jan 8, 2018

Study contacts

Flaminio Sessa, MD
principal investigator · Catholic University Rome

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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