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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01356732

Acronym

REANURSUF

Enrollment

Registered

2011-05-19

Start date

2010-01-31

Completion date

2010-10-31

Last updated

2017-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

mechanical ventilation, Midazolam, Ramsay, Sufentanil

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.

Interventions

DRUGSufentanil

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026