Dettagli per singolo studio

DEC-NET Serial number FR536

Published online	06/07/2006 15.34.00
Last updated	06/07/2006 16.30.55

Other protocol ID number	N/A
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	UNSPECIFIED ADVERSE EFFECT OF DRUG MEDICINAL AND B
Experimental drug
SEVOFLURANE Treatment regimen (dosage and duration)
DESFLURANE Treatment regimen (dosage and duration)
ISOFLURANE Treatment regimen (dosage and duration)
Gender	Both
Age (range)	> 2 years-10 years
Eligibility criteria
Inclusion criteria
- Age from 2 to 10 years - Children hospitalized for a benign surgery procedures above the umbilicus : either urologic (cryptorchism, circumcision) or digestive (inguinal hernia not strangled, simple appendicectomy). -Weight over 10 kg -Written consent parental and the child
Exclusion criteria
-Children with history of oesophageal atresia and stenosis patients with oesophageal varices, a severe gastroesophageal reflux -Unstable patients (class 3 or 4 of the score of American Society of Anesthesiology) and patients operated in urgency -Febrile children (> 37°5 C) before surgery -Use of the same type of volatile anesthetic agent to initiate anesthesia -Refusal of the one of the parents or the child
Trial design/methodology
Phase	4
Kind of study
Design	Randomised
Purpose of study
-To compare the hemodynamic effects of inhaled anesthetic agents currently used for pediatric anesthesia -To evaluate the pediatric use of Dynemo 3000
Primary outcomes
Screening of possible side effects during the immediate post-operative phase and during hospital stay in the paediatric ward until discharge (24h with 48 H).
Secondary outcomes
-
Summary of study design, objectives, and ongoing research findings
This study involves children from 2 to 10 years operated in the service of pediatric general surgery of programmed urologic or digestive minor under-umbilical (cryptorchism, inguinal hernias,.). Oesophagel catheter is placed and halogenous agent (either Isoflurane,or Desflurane or Sevoflurane) is randomly administered, at increasing concentrations up to 1.5 the minimum alveolar concentration. Hemodynamic parameters given by the oesophageal doppler(Dynemo 3000)will be registered. The possible side effects, in particular those dependent on a traumatism by the catheter, will be systematically look for.