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

Primary Purpose

Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Sevoflurane 8%
Sevoflurane 5%
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Emergence delirium, Sevoflurane, Pediatric anesthesia

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • División de Anestesia - Facultad de Medicina Pontificia Universidad CatólicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

High dose sevoflurane

Low dose sevoflurane

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Emergence delirium
Emergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale every 15 minutes

Secondary Outcome Measures

Pain
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.
Bispectral Index
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
Heart rate
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
Blood pressure
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

Full Information

First Posted
March 7, 2016
Last Updated
March 7, 2016
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT02707016
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Emergence delirium, Sevoflurane, Pediatric anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose sevoflurane
Arm Type
Other
Arm Description
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.
Arm Title
Low dose sevoflurane
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sevoflurane 8%
Other Intervention Name(s)
Sevorane
Intervention Description
Sevoflurane 8% (high dose) during anesthesia induction
Intervention Type
Other
Intervention Name(s)
Sevoflurane 5%
Other Intervention Name(s)
Sevorane
Intervention Description
Sevoflurane 5% (low dose) during anesthesia induction
Primary Outcome Measure Information:
Title
Emergence delirium
Description
Emergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale every 15 minutes
Time Frame
From end of gas administration up to 2 hours after surgery
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
From end of gas administration up to 2 hours after surgery
Title
Bispectral Index
Description
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
Time Frame
From start of induction until end of surgery
Title
Heart rate
Description
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
Time Frame
From start of induction until end of surgery
Title
Blood pressure
Description
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
Time Frame
From start of induction until end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Aeschlimann, MD
Phone
+56 2 2354 3415
Email
nicolas@med.puc.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Aeschlimann, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8330024
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolás Aeschlimann, MD
Phone
+56 2 23543415
Email
nicolas@med.puc.cl
First Name & Middle Initial & Last Name & Degree
Nicolas Aeschlimann, MD
First Name & Middle Initial & Last Name & Degree
Alejandro Gonzalez, MD
First Name & Middle Initial & Last Name & Degree
Javiera Benavides, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Different Doses of Sevoflurane During Induction of Anesthesia on Emergence Delirium in Children

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