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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356732
First Posted: May 19, 2011
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Toulouse
  Purpose

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.


Condition Intervention Phase
Pain Drug: Sufentanil Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

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) [ Time Frame: five days ]

Enrollment: 25
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sufentanil Drug: Sufentanil
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356732


Locations
France
Service de réanimation - Hôpital Purpan
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Olivier Fourcade University Hospital, Toulouse
  More Information

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01356732     History of Changes
Other Study ID Numbers: 09 162 02
First Submitted: April 19, 2011
First Posted: May 19, 2011
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
mechanical ventilation
Midazolam
Ramsay
Sufentanil

Additional relevant MeSH terms:
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics