Clinical trial NCT02707016: Different Doses of Sevoflurane During Induction of Anesthesia on Emergence Delirium in Children
Official title: Emergence Delirium in Children: a Randomized Clinical Trial of Different Doses of Sevoflurane During Induction of Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Keywords: Emergence delirium
Sevoflurane
Pediatric anesthesia
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to reduce the incidence of emergence delirium in children aged 2-7 years old by using two different doses of sevoflurane during inhalatory induction of anesthesia.

Detailed description: Sevoflurane is an inhalational agent widely used in general anesthesia, both for induction and maintenance of anesthesia. It is not irritative on the airways and has a pleasant smell. Within their properties are: low partition coefficient blood / gas (rapid induction and awakening), low heart, liver and kidney toxicity. Inhalational induction in pediatric anesthesia with this agent is frequent to avoid vein puncture in awake patients and is generally done with maximum doses available to obtain a fast loss of consciousness.

Emergence delirium (ED) is frequent in children. It is defined as a mental disorder during recovery from general anesthesia that may include hallucinations, delusions and confusion expressed by crying, restlessness and involuntary physical activity. It usually lasts for 30 minutes and is not necessarily related to pain. During this episodes, children can hurt themselves or others, lose vascular catheters or other invasive devices. ED can generate anxiety and stress in caretakers, delay transfer from Post-Anesthesia Care Units (PACU), increase costs of medical attention and increase use of opioids or other sedatives.

Many interventions have been used to decrease the appearance of ED such as dexmedetomidine, clonidine, benzodiazepines, propofol among others but with no consistent results. The use of sevoflurane has been linked with ED in children and it can induce seizures in high doses (over 2 MAC).

The aim of this study is to test whether using a lower dose of sevoflurane (5%) during induction of anesthesia in children results in less ED than using higher doses (8%).

Eligibility criteria: Inclusion Criteria:

* Surgery with caudal block: circumcision (phimosis), hernioplasty (inguinal hernia)
* American Society of Anesthesiologists (ASA) classification of I or II

Exclusion Criteria:

* Use of Total Intravenous Anesthesia (TIVA)
* Familiar or personal history of Malignant Hyperthermia
* Contraindication to caudal block
* Parents or legal guardians do not sign informed consent

Primary outcomes:
measure: Emergence delirium
timeFrame: From end of gas administration up to 2 hours after surgery
Secondary outcomes:
measure: Pain
timeFrame: From end of gas administration up to 2 hours after surgery
measure: Bispectral Index
timeFrame: From start of induction until end of surgery
measure: Heart rate
timeFrame: From start of induction until end of surgery
measure: Blood pressure
timeFrame: From start of induction until end of surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
state: Región Metropolitana
Study officials:
affiliation: Assistant Professor
name: Nicolas Aeschlimann, MD
role: PRINCIPAL_INVESTIGATOR
References:
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