NCT03378674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

4.5 years

First QC Date

December 14, 2017

Last Update Submit

January 5, 2018

Conditions

Stress Response

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

remifentanil infusion of 0,15 mcg/Kg/min

Drug: Remifentanil Injectable Product

Group B

ACTIVE COMPARATOR

remifentanil infusion of 0,3 mcg/Kg/min

Drug: Remifentanil Injectable Product

Interventions

Remifentanil Injectable ProductDRUG

remifentanil: 0,15 mcg/kg/min

Group AGroup B

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (4)

  • 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.

    PMID: 8313088BACKGROUND

  • 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.

    PMID: 12732764BACKGROUND

  • 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.

    PMID: 24711760BACKGROUND

  • 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.

    PMID: 10927999BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Flaminio Sessa, MD

    Catholic University Rome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 20, 2017

Study Start

January 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

IT(1)