Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 658 for:    Sevoflurane

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02707016
Recruitment Status : Unknown
Verified March 2016 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : March 11, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Delirium Other: Sevoflurane 8% Other: Sevoflurane 5% Not Applicable

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%).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Emergence Delirium in Children: a Randomized Clinical Trial of Different Doses of Sevoflurane During Induction of Anesthesia
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Sevoflurane

Arm Intervention/treatment
High dose sevoflurane

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.

Other: Sevoflurane 8%
Sevoflurane 8% (high dose) during anesthesia induction
Other Name: Sevorane

Low dose sevoflurane

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.

Other: Sevoflurane 5%
Sevoflurane 5% (low dose) during anesthesia induction
Other Name: Sevorane




Primary Outcome Measures :
  1. Emergence delirium [ Time Frame: 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 :
  1. Pain [ Time Frame: 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.

  2. Bispectral Index [ Time Frame: 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

  3. Heart rate [ Time Frame: 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

  4. Blood pressure [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707016


Contacts
Layout table for location contacts
Contact: Nicolas Aeschlimann, MD +56 2 2354 3415 nicolas@med.puc.cl

Locations
Layout table for location information
Chile
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica Recruiting
Santiago, Región Metropolitana, Chile, 8330024
Contact: Nicolás Aeschlimann, MD    +56 2 23543415    nicolas@med.puc.cl   
Principal Investigator: Nicolas Aeschlimann, MD         
Sub-Investigator: Alejandro Gonzalez, MD         
Sub-Investigator: Javiera Benavides, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Layout table for investigator information
Principal Investigator: Nicolas Aeschlimann, MD Assistant Professor

Publications:

Layout table for additonal information
Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02707016     History of Changes
Other Study ID Numbers: 15-153
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pontificia Universidad Catolica de Chile:
Emergence delirium
Sevoflurane
Pediatric anesthesia

Additional relevant MeSH terms:
Layout table for MeSH terms
Sevoflurane
Delirium
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General