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

Not Applicable

• Conditions: Delirium
• Interventions: Other: Sevoflurane 8%; Other: Sevoflurane 5%

• Registration Number: NCT02707016
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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%).

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-07
• Last Update Submitted: 2016-03-07
• Study First Posted: 2016-03-11
• Last Update Posted: 2016-03-11
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose sevoflurane	Sevoflurane 8%	Inhaled sevoflurane 8% during induction of general anesthesia (from the start of gas administration to the insertion of a laryngeal mask). After laryngeal mask insertion, sevoflurane will be reduced to 4%. Caudal block with L-bupivacaine 0.25% will be performed in all children. After caudal block, sevoflurane will be reduced to 0.75 MAC according to age of the child and maintained until the end of surgery After surgery, PAED and pain scales will be administered every 15 minutes up to 2 hours after surgery.
Low dose sevoflurane	Sevoflurane 5%	Inhaled sevoflurane 5% during induction of general anesthesia (from the start of gas administration to the insertion of a laryngeal mask). After laryngeal mask insertion, sevoflurane will be reduced to 4%. Caudal block with L-bupivacaine 0.25% will be performed in all children. After caudal block, sevoflurane will be reduced to 0.75 MAC according to age of the child and maintained until the end of surgery After surgery, PAED and pain scales will be administered every 15 minutes up to 2 hours after surgery.

Primary Outcome Measures

Name	Time	Method
Emergence delirium	From end of gas administration up to 2 hours after surgery	Emergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale every 15 minutes

Secondary Outcome Measures

Name	Time	Method
Pain	From end of gas administration up to 2 hours after surgery	Pain 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.
Heart rate	From start of induction until end of surgery	Measured 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
Bispectral Index	From start of induction until end of surgery	Bispectral 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
Blood pressure	From start of induction until end of surgery	Measured 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

Trial Locations

Locations (1)

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica; 🇨🇱 Santiago, Región Metropolitana, Chile