AGITATION AFTER POSTOPERATIVE ANESTHESIA IN PEDIATRIC PATIENTS
Conditions
Interventions
Trade Name: SEVORANE
Product Name: SEVOFLURANO
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: SEVOFLURANO
CAS Number: 28523-86-6
Other descriptive name: SEVORANE
Concentration uni
Sponsors
Servicio de Anestesia Infantil. Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 1-10 years. 2. Risk anesthetic ASA (American Society of Anesthesiologists) I or II. 3. Scheduled for ambulatory surgery procedures (herniorrhaphies, phimosis, prepucioplastias, orchidopexies). 4. Fasting 6 hours for regular formula or solid foods from 4 hours to breast milk, and 2 hours for water. 5. whose parents and / or legal representatives, subjects agree to participate in the study by signing the informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients 1-10 years. 2. Risk anesthetic ASA (American Society of Anesthesiologists) I or II. 3. Scheduled for ambulatory surgery procedures (herniorrhaphies, phimosis, prepucioplastias, orchidopexies). 4. Fasting 6 hours for regular formula or solid foods from 4 hours to breast milk, and 2 hours for water. 5. Whose parents and / or legal Representatives, subjects agree to Participate in the study by signing the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the incidence and characteristics of postoperative agitation in pediatric patients undergoing general anesthesia with sevoflurane or desflurane combined with a technique of regional anesthesia for peripheral intra and postoperative analgesia for ambulatory surgery procedures (CMA).;Secondary Objective: a) Assessment of other factors that may influence postoperative agitation: demographics (age, gender), degree of postoperative anxiety, premedication, duration of anesthesia and surgery, intraoperative and postoperative events, postoperative pain, and time stay at Unit Post-Anesthesia Recovery (PACU). b) Monitoring (by telephone) during the first 24 hours of the patient after discharge, and evaluation of possible side effects of anesthesia. Track 7 days for patients who developed complications 24 hours.;Primary end point(s): Assess the incidence and characteristics of postoperative agitation in pediatric patients undergoing general anesthesia with sevoflurane or desflurane combined with a technique of regional anesthesia for peripheral intra and postoperative analgesia for ambulatory surgery procedures (CMA) mainly herniorrhaphies, circumcisions, surgeries hydrocele, prepucioplastias and orchidopexies.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Assessment of other factors that may influence postoperative agitation: demographics (age, gender), degree of preoperative anxiety, premedication, duration of anesthesia and surgery, intraoperative and postoperative events, postoperative pain, and time stay at Unit Post-Anesthesia Recovery (PACU). b) Monitoring (by telephone) during the first 24 hours of the patient after discharge, and evaluation of possible side effects of anesthesia. Track 7 days for patients who developed complications 24 hours.;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Spain
Contacts
Public ContactHOI YAN TONG
SERVICIO DE ANESTESIA INFANTIL, HOSPITAL UNIVERSITARIO LA PAZ
Outcome results
None listed