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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Sufentanil	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
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.
Study Start Date :	January 2010
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	October 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Génestal 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.

Responsible Party:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT01356732 History of Changes
Other Study ID Numbers:	09 162 02
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