Determination of the ED95 of intrathecal hyperbaric prilocaine with sufentanil for scheduled cesarean delivery: a dose-finding study based on the continual reassessment method.
Adult
Analgesics, Opioid
/ pharmacology
Anesthesia, Obstetrical
/ methods
Anesthesia, Spinal
/ methods
Anesthetics, Local
/ pharmacology
Cesarean Section
/ methods
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Pregnancy
Prilocaine
/ pharmacology
Prospective Studies
Sufentanil
/ pharmacology
Cesarean section
Continual reassessment method
ED95
Hyperbaric prilocaine
Sufentanil
Journal
BMC anesthesiology
ISSN: 1471-2253
Titre abrégé: BMC Anesthesiol
Pays: England
ID NLM: 100968535
Informations de publication
Date de publication:
26 11 2020
26 11 2020
Historique:
received:
29
04
2020
accepted:
03
11
2020
entrez:
27
11
2020
pubmed:
28
11
2020
medline:
8
9
2021
Statut:
epublish
Résumé
Scheduled cesarean section is routinely performed under spinal anesthesia using hyperbaric bupivacaine. The current study was undertaken to determine the clinically relevant 95% effective dose of intrathecal 2% hyperbaric prilocaine co-administered with sufentanil for scheduled cesarean section, using continual reassessment method. We conducted a dose-response, prospective, double-blinded study to determine the ED95 values of intrathecal hyperbaric prilocaine used with 2,5 mcg of sufentanil and 100 mcg of morphine for cesarean delivery. Each parturient enrolled in the study received an intrathecal dose of hyperbaric prilocaine determined by the CRM and the success or failure of the block was assessed as being the primary endpoint. The doses given for each cohort varied from 35 to 50 mg of HP, according to the CRM, with a final ED95 lying between 45 and 50 mg of Prilocaine after completion of the 10 cohorts. Few side effects were reported and patients were globally satisfied. The ED95 of intrathecal hyperbaric prilocaine with sufentanil 2.5 μg and morphine 100 μg for elective cesarean delivery was found to be between 45 and 50 mg. It may be an interesting alternative to other long-lasting local anesthetics in this context. The study was registered on January 30, 2017 - retrospectively registered - and results posted at the public database clinicaltrials.gov ( NCT03036384 ).
Sections du résumé
BACKGROUND
Scheduled cesarean section is routinely performed under spinal anesthesia using hyperbaric bupivacaine. The current study was undertaken to determine the clinically relevant 95% effective dose of intrathecal 2% hyperbaric prilocaine co-administered with sufentanil for scheduled cesarean section, using continual reassessment method.
METHODS
We conducted a dose-response, prospective, double-blinded study to determine the ED95 values of intrathecal hyperbaric prilocaine used with 2,5 mcg of sufentanil and 100 mcg of morphine for cesarean delivery. Each parturient enrolled in the study received an intrathecal dose of hyperbaric prilocaine determined by the CRM and the success or failure of the block was assessed as being the primary endpoint.
RESULTS
The doses given for each cohort varied from 35 to 50 mg of HP, according to the CRM, with a final ED95 lying between 45 and 50 mg of Prilocaine after completion of the 10 cohorts. Few side effects were reported and patients were globally satisfied.
CONCLUSIONS
The ED95 of intrathecal hyperbaric prilocaine with sufentanil 2.5 μg and morphine 100 μg for elective cesarean delivery was found to be between 45 and 50 mg. It may be an interesting alternative to other long-lasting local anesthetics in this context.
TRIAL REGISTRATION
The study was registered on January 30, 2017 - retrospectively registered - and results posted at the public database clinicaltrials.gov ( NCT03036384 ).
Identifiants
pubmed: 33243149
doi: 10.1186/s12871-020-01199-0
pii: 10.1186/s12871-020-01199-0
pmc: PMC7690017
doi:
Substances chimiques
Analgesics, Opioid
0
Anesthetics, Local
0
Prilocaine
046O35D44R
Sufentanil
AFE2YW0IIZ
Banques de données
ClinicalTrials.gov
['NCT03036384']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
293Références
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