CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Isobaric 2-chloroprocainedrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03882489
NCT03882489N/ACompleted

Estimation of Effective Dose 95 (ED95) of Intrathecal Isobaric 2-chloroprocaine (2-CP) Based on the Height (cm) of a Patient Undergoing Ambulatory Knee Arthroscopy : Dose-finding Study Based on the Continual Reassessment Method (CRM)

Centre Hospitalier Universitaire Saint Pierre·observational·Posted Mar 20, 2019·Updated Oct 7, 2019

In Brief

An observational study evaluating Isobaric 2-chloroprocaine for Knee Arthroscopy. Completed, enrolled 120 participants across 1 site.

Detailed Summary

In ambulatory surgery, the choice of the local anesthetic used is essential. The ideal local anesthetic must allow a quick installation of the spinal block, a duration of the sensory block adapted to the surgery with a minimum of side effects. These side effects include bradycardia, hypotension and block failure during the intraoperative period; bladder retention, transient neurological disorders during the post-operative period. The achievement of kinetic objectives associated with a reduction in side effects is related to the choice of local anesthetic and the dose administered. However, there are interindividual pharmacokinetic variations that make it difficult to predict the effective dose and the unfortunate occurrence of side effects. In this context, the height of the patient is a criterion involved in the level, the duration of the sensitive motor block and therefore the side effects The local anesthetic of the amino ester family, isobaric 2-chloroprocaine (2-CP) has been successfully used for spinal anesthesia since several decades. With a short duration of action, it is preferred to other anesthetics for the short-term outpatient surgeries. However, the effective dose 95 (ED95) of intrathecal isobaric 2-CP is currently unknown. The purpose of this prospective study is to determine the ED95 of the spinal 2-CP using the continuous re-evaluation method (Continual Reassessment Method) (CRM) based on patient's height

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 20, 2019
Enrollment StartApr 11, 2019
Primary CompletionAug 16, 2019
Study CompletionAug 17, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.3 years ago

Interventions

Isobaric 2-chloroprocainedrug

The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.