Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients (REANURSUF)
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ClinicalTrials.gov Identifier: NCT01356732 |
Recruitment Status
:
Completed
First Posted
: May 19, 2011
Last Update Posted
: May 11, 2017
|
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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 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 |

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
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- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
Service de réanimation - Hôpital Purpan | |
Toulouse, France |
Principal Investigator: | Olivier Fourcade | University Hospital, Toulouse |
Publications of Results:
Responsible Party: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT01356732 History of Changes |
Other Study ID Numbers: |
09 162 02 |
First Posted: | May 19, 2011 Key Record Dates |
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 |