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Different Doses of Sevoflurane During Induction of Anesthesia on Emergence Delirium in Children

Emergence Delirium in Children: a Randomized Clinical Trial of Different Doses of Sevoflurane During Induction of Anesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02707016
Enrollment
80
Registered
2016-03-11
Start date
2015-12-31
Completion date
2016-12-31
Last updated
2016-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Emergence delirium, Sevoflurane, Pediatric anesthesia

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%).

Interventions

OTHERSevoflurane 8%

Sevoflurane 8% (high dose) during anesthesia induction

OTHERSevoflurane 5%

Sevoflurane 5% (low dose) during anesthesia induction

Sponsors

Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emergence deliriumFrom end of gas administration up to 2 hours after surgeryEmergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale every 15 minutes

Secondary

MeasureTime frameDescription
PainFrom end of gas administration up to 2 hours after surgeryPain will be evaluated according to age of children: CHIPPS scale for under 3 years, faces for children between 4 and 6 years old, Visual Analogue Scale (VAS) with older children.
Bispectral IndexFrom start of induction until end of surgeryBispectral Index (BIS) monitoring will be used during surgery and recorded at following times: after insertion of IV access, after insertion of laryngeal mask, after caudal block, after lowering dose of sevoflurane to 0.75 MAC, after skin incision, at the end of surgery
Heart rateFrom start of induction until end of surgeryMeasured with pulse oximetry, recorded at following times: after insertion of IV access, after insertion of laryngeal mask, after caudal block, after lowering dose of sevoflurane to 0.75 MAC, after skin incision, at the end of surgery
Blood pressureFrom start of induction until end of surgeryMeasured with non-invasive blood pressure cuff, recorded at following times: after insertion of IV access, after insertion of laryngeal mask, after caudal block, after lowering dose of sevoflurane to 0.75 MAC, after skin incision, at the end of surgery

Countries

Chile

Contacts

Primary ContactNicolas Aeschlimann, MD
nicolas@med.puc.cl+56 2 2354 3415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026