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Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients (REANURSUF)

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Sufentanil
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring mechanical ventilation, Midazolam, Ramsay, Sufentanil

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 48th hour of mechanical ventilation
  • mechanical invasive ventilation
  • 48th hour midazolam sedation
  • Behavioral Pain Scale (BPS) at 3 or 4
  • mechanical ventilation of 5 days duration

Exclusion Criteria:

  • Pregnant or breast-feeding woman
  • Impossibility of evaluation of the BPS tetraplegia, curare-link , post anoxic coma encephalic death
  • Indication of deep conscious-sedation, malignant cranial trauma, toxic shock, acute respiratory distress syndrome
  • Extra renal clearance OU people in hemodialysis
  • Severe renal failure (creatinine clearance <15ml/min)
  • Severe hepatic failure
  • State of consciousness with impossibility to use self-assessment scale
  • Body mass index >35 ou <18
  • Sufentanil midazolam paracetamol allergy or contraindication
  • Guardianship or confirmed criminal Subject who give his informed consent
  • Morphinic other than sufentanil (morphine, alfentanil fentanyl, remifentanil, nalbuphine, codeine, buprenorphine)
  • Antalgic other than sufentanil and paracetamol ( tramadol nefopam, ketamine, dextropropoxyphene, non steroidal anti-inflammatory drug )
  • MAO inhibitors

Sites / Locations

  • Service de réanimation - Hôpital Purpan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sufentanil

Arm Description

Outcomes

Primary Outcome Measures

The effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4)

Secondary Outcome Measures

Full Information

First Posted
April 19, 2011
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01356732
Brief Title
Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients
Acronym
REANURSUF
Official Title
Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU) however their treatment remains unclear. This prospective pharmacodynamic study relates to the analgesia of procedural pains. The primary objective was to determine the 90% effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated patients. Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation, reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were included. During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new LD until BPS was at 3 or 4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
mechanical ventilation, Midazolam, Ramsay, Sufentanil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sufentanil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
From 0 to 0,05 µg/kg to a maximum of 4 µg/kg of sufentanil. 7 minutes before nursing 3 nursing per day during 3 days
Primary Outcome Measure Information:
Title
The effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4)
Time Frame
five days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 48th hour of mechanical ventilation mechanical invasive ventilation 48th hour midazolam sedation Behavioral Pain Scale (BPS) at 3 or 4 mechanical ventilation of 5 days duration Exclusion Criteria: Pregnant or breast-feeding woman Impossibility of evaluation of the BPS tetraplegia, curare-link , post anoxic coma encephalic death Indication of deep conscious-sedation, malignant cranial trauma, toxic shock, acute respiratory distress syndrome Extra renal clearance OU people in hemodialysis Severe renal failure (creatinine clearance <15ml/min) Severe hepatic failure State of consciousness with impossibility to use self-assessment scale Body mass index >35 ou <18 Sufentanil midazolam paracetamol allergy or contraindication Guardianship or confirmed criminal Subject who give his informed consent Morphinic other than sufentanil (morphine, alfentanil fentanyl, remifentanil, nalbuphine, codeine, buprenorphine) Antalgic other than sufentanil and paracetamol ( tramadol nefopam, ketamine, dextropropoxyphene, non steroidal anti-inflammatory drug ) MAO inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Fourcade
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de réanimation - Hôpital Purpan
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22388706
Citation
Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Genestal M, Minville V, Fourcade O. The 90% effective dose of a sufentanil bolus for the management of painful positioning in intubated patients in the ICU. Eur J Anaesthesiol. 2012 Jun;29(6):280-5. doi: 10.1097/EJA.0b013e328352234d.
Results Reference
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Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients

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