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:
University Hospital, Toulouse
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01356732
First received: April 19, 2011
Last updated: February 4, 2016
Last verified: February 2016
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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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
MedlinePlus related topics:
Pressure Sores
Drug Information available for:
Sufentanil citrate
U.S. FDA Resources
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 ] [ Designated as safety issue: Yes ]
| 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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01356732
Please refer to this study by its ClinicalTrials.gov identifier: 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01356732 History of Changes |
| Other Study ID Numbers: | 09 162 02 |
| Study First Received: | April 19, 2011 |
| Last Updated: | February 4, 2016 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on September 26, 2016