DeliriumNCT02707016
Different Doses of Sevoflurane During Induction of Anesthesia on Emergence Delirium in Children
A study testing Sevoflurane 8% and Sevoflurane 5% in people with Delirium, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Delirium
- What is being tested?
- Sevoflurane 8% and Sevoflurane 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Surgery with caudal block: circumcision (phimosis), hernioplasty (inguinal hernia)
- American Society of Anesthesiologists (ASA) classification of I or II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
Santiago, Santiago Metropolitan, 8330024
Nicolás Aeschlimann, MD, +56 2 23543415, nicolas@med.puc.cl
Nicolas Aeschlimann, MD
About this study
Official title: Emergence Delirium in Children: a Randomized Clinical Trial of Different Doses of Sevoflurane During Induction of Anesthesia
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.
Read the 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%).
- Conditions
- Delirium
- Being tested
- Sevoflurane 8%, Sevoflurane 5%
- Keywords
- Emergence delirium, Sevoflurane, Pediatric anesthesia
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane 8%Other
Also called Sevorane
Sevoflurane 8% (high dose) during anesthesia induction
Sevoflurane 5%Other
Also called Sevorane
Sevoflurane 5% (low dose) during anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| High dose sevoflurane | Other | 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. Receives: Other: Sevoflurane 8% |
| Low dose sevoflurane | Other | 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. Receives: Other: Sevoflurane 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence delirium
Emergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale every 15 minutes
Measured: From end of gas administration up to 2 hours after surgery
Secondary outcomes (4)
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.
Measured: From end of gas administration up to 2 hours after surgery
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
Measured: From start of induction until 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
Measured: From start of induction until 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
Measured: From start of induction until end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Aeschlimann, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707016
- Sponsor's protocol ID
- 15-153
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bajwa SA, Costi D, Cyna AM. A comparison of emergence delirium scales following general anesthesia in children. Paediatr Anaesth. 2010 Aug;20(8):704-11. doi: 10.1111/j.1460-9592.2010.03328.x.
PubMed 20497353Li X, Xia Q, Li W. Comparison of the effects of dezocine, fentanyl, and placebo on emergence agitation after sevoflurane anesthesia in children. Int J Clin Pharmacol Ther. 2015 Mar;53(3):241-6. doi: 10.5414/CP202184.
PubMed 25669611Oofuvong M, Siripruekpong S, Naklongdee J, Hnookong R, Lakateb C. Comparison the incidence of emergence agitation between sevoflurane and desflurane after pediatric ambulatory urologic surgery. J Med Assoc Thai. 2013 Nov;96(11):1470-5.
PubMed 24428097Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
PubMed 15114210Ozcan A, Kaya AG, Ozcan N, Karaaslan GM, Er E, Baltaci B, Basar H. [Effects of ketamine and midazolam on emergence agitation after sevoflurane anaesthesia in children receiving caudal block: a randomized trial]. Rev Bras Anestesiol. 2014 Nov-Dec;64(6):377-81. doi: 10.1016/j.bjan.2014.01.004. Epub 2014 Aug 29. Portuguese.
PubMed 25437692Saxena A, Sethi A, Agarwal V, Godwin RB. Effect of caudal clonidine on emergence agitation and postoperative analgesia after sevoflurane anaesthesia in children: Randomised comparison of two doses. Indian J Anaesth. 2014 Nov-Dec;58(6):719-25. doi: 10.4103/0019-5049.147163.
PubMed 25624536Abdel-Ma'boud MA. Effect of dexemeditomedine and propofol on the prevention of emergence agitation following sevoflurane anesthesia in Egyptian children. J Egypt Soc Parasitol. 2014 Dec;44(3):687-94. doi: 10.12816/0007872.
PubMed 25643510Zhang C, Hu J, Liu X, Yan J. Effects of intravenous dexmedetomidine on emergence agitation in children under sevoflurane anesthesia: a meta-analysis of randomized controlled trials. PLoS One. 2014 Jun 16;9(6):e99718. doi: 10.1371/journal.pone.0099718. eCollection 2014.
PubMed 24932765Costi D, Cyna AM, Ahmed S, Stephens K, Strickland P, Ellwood J, Larsson JN, Chooi C, Burgoyne LL, Middleton P. Effects of sevoflurane versus other general anaesthesia on emergence agitation in children. Cochrane Database Syst Rev. 2014 Sep 12;2014(9):CD007084. doi: 10.1002/14651858.CD007084.pub2.
PubMed 25212274Dahmani S, Delivet H, Hilly J. Emergence delirium in children: an update. Curr Opin Anaesthesiol. 2014 Jun;27(3):309-15. doi: 10.1097/ACO.0000000000000076.
PubMed 24784918Gibert S, Sabourdin N, Louvet N, Moutard ML, Piat V, Guye ML, Rigouzzo A, Constant I. Epileptogenic effect of sevoflurane: determination of the minimal alveolar concentration of sevoflurane associated with major epileptoid signs in children. Anesthesiology. 2012 Dec;117(6):1253-61. doi: 10.1097/ALN.0b013e318273e272.
PubMed 23103557Schultz B, Otto C, Schultz A, Osthaus WA, Krauss T, Dieck T, Sander B, Rahe-Meyer N, Raymondos K. Incidence of epileptiform EEG activity in children during mask induction of anaesthesia with brief administration of 8% sevoflurane. PLoS One. 2012;7(7):e40903. doi: 10.1371/journal.pone.0040903. Epub 2012 Jul 19.
PubMed 22829896Kreuzer I, Osthaus WA, Schultz A, Schultz B. Influence of the sevoflurane concentration on the occurrence of epileptiform EEG patterns. PLoS One. 2014 Feb 26;9(2):e89191. doi: 10.1371/journal.pone.0089191. eCollection 2014.
PubMed 24586585Pilge S, Jordan D, Kochs EF, Schneider G. Sevoflurane-induced epileptiform electroencephalographic activity and generalized tonic-clonic seizures in a volunteer study. Anesthesiology. 2013 Aug;119(2):447. doi: 10.1097/ALN.0b013e31827335b9. No abstract available.
PubMed 23221897Julliac B, Cotillon P, Guehl D, Richez B, Sztark F. Target-controlled induction with 2.5% sevoflurane does not avoid the risk of electroencephalographic abnormalities. Ann Fr Anesth Reanim. 2013 Oct;32(10):e143-8. doi: 10.1016/j.annfar.2013.07.812. Epub 2013 Sep 12.
PubMed 24035611
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence Delirium in Children: a Randomized Clinical Trial of Different Doses of Sevoflurane During Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT02707016
- Acronym / sponsor ID
- 15-153
- Conditions
- Delirium
- Keywords
- Emergence delirium, Sevoflurane, Pediatric anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose sevoflurane | Other | Other: 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 | Other | Other: 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. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Surgery with caudal block: circumcision (phimosis), hernioplasty (inguinal hernia)
- American Society of Anesthesiologists (ASA) classification of I or II
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane 8%Also: SevoraneSevoflurane 8% (high dose) during anesthesia induction | Other | High dose sevoflurane |
| Sevoflurane 5%Also: SevoraneSevoflurane 5% (low dose) during anesthesia induction | Other | Low dose sevoflurane |
Primary outcome
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
4 secondary outcomes
Pain
Time frame: From end of gas administration up to 2 hours after surgery
Bispectral Index
Time frame: From start of induction until end of surgery
Heart rate
Time frame: From start of induction until end of surgery
Blood pressure
Time frame: From start of induction until end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Background: PubMed 20497353Bajwa SA, Costi D, Cyna AM. A comparison of emergence delirium scales following general anesthesia in children. Paediatr Anaesth. 2010 Aug;20(8):704-11. doi: 10.1111/j.1460-9592.2010.03328.x.
- Background: PubMed 25669611Li X, Xia Q, Li W. Comparison of the effects of dezocine, fentanyl, and placebo on emergence agitation after sevoflurane anesthesia in children. Int J Clin Pharmacol Ther. 2015 Mar;53(3):241-6. doi: 10.5414/CP202184.
- Background: PubMed 24428097Oofuvong M, Siripruekpong S, Naklongdee J, Hnookong R, Lakateb C. Comparison the incidence of emergence agitation between sevoflurane and desflurane after pediatric ambulatory urologic surgery. J Med Assoc Thai. 2013 Nov;96(11):1470-5.
- Background: PubMed 15114210Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
- Background: PubMed 25437692Ozcan A, Kaya AG, Ozcan N, Karaaslan GM, Er E, Baltaci B, Basar H. [Effects of ketamine and midazolam on emergence agitation after sevoflurane anaesthesia in children receiving caudal block: a randomized trial]. Rev Bras Anestesiol. 2014 Nov-Dec;64(6):377-81. doi: 10.1016/j.bjan.2014.01.004. Epub 2014 Aug 29. Portuguese.
- Background: PubMed 25624536Saxena A, Sethi A, Agarwal V, Godwin RB. Effect of caudal clonidine on emergence agitation and postoperative analgesia after sevoflurane anaesthesia in children: Randomised comparison of two doses. Indian J Anaesth. 2014 Nov-Dec;58(6):719-25. doi: 10.4103/0019-5049.147163.
- Background: PubMed 25643510Abdel-Ma'boud MA. Effect of dexemeditomedine and propofol on the prevention of emergence agitation following sevoflurane anesthesia in Egyptian children. J Egypt Soc Parasitol. 2014 Dec;44(3):687-94. doi: 10.12816/0007872.
- Background: PubMed 24932765Zhang C, Hu J, Liu X, Yan J. Effects of intravenous dexmedetomidine on emergence agitation in children under sevoflurane anesthesia: a meta-analysis of randomized controlled trials. PLoS One. 2014 Jun 16;9(6):e99718. doi: 10.1371/journal.pone.0099718. eCollection 2014.
- Background: PubMed 25212274Costi D, Cyna AM, Ahmed S, Stephens K, Strickland P, Ellwood J, Larsson JN, Chooi C, Burgoyne LL, Middleton P. Effects of sevoflurane versus other general anaesthesia on emergence agitation in children. Cochrane Database Syst Rev. 2014 Sep 12;2014(9):CD007084. doi: 10.1002/14651858.CD007084.pub2.
- Background: PubMed 24784918Dahmani S, Delivet H, Hilly J. Emergence delirium in children: an update. Curr Opin Anaesthesiol. 2014 Jun;27(3):309-15. doi: 10.1097/ACO.0000000000000076.
- Background: PubMed 23103557Gibert S, Sabourdin N, Louvet N, Moutard ML, Piat V, Guye ML, Rigouzzo A, Constant I. Epileptogenic effect of sevoflurane: determination of the minimal alveolar concentration of sevoflurane associated with major epileptoid signs in children. Anesthesiology. 2012 Dec;117(6):1253-61. doi: 10.1097/ALN.0b013e318273e272.
- Background: PubMed 22829896Schultz B, Otto C, Schultz A, Osthaus WA, Krauss T, Dieck T, Sander B, Rahe-Meyer N, Raymondos K. Incidence of epileptiform EEG activity in children during mask induction of anaesthesia with brief administration of 8% sevoflurane. PLoS One. 2012;7(7):e40903. doi: 10.1371/journal.pone.0040903. Epub 2012 Jul 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Aeschlimann, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane 8% and Sevoflurane 5% in people with Delirium, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Aeschlimann, MD (+56 2 2354 3415, nicolas@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence delirium (time frame: From end of gas administration up to 2 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707016, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.