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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil

NCT04959812

Healthy

COMPLETED PHASE1/PHASE2

Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

NCT01320475

Thoracic Surgery

TERMINATED PHASE4

Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

NCT04387136

Pain Pain, Acute Anesthesia

COMPLETED PHASE4

Effect of Sufentanil and Ropivacaine

NCT02488291

Anesthesia Complications

COMPLETED NA

Onset of Labour Epidural Analgesia With Different Concentration Bupivacaine and Different Doses of Sufentanyl

NCT03395600

Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sufentanil

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No