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

NCT02707016 | Unknown DMC

• 1 other identifier: 15-153
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Emergence delirium; Sevoflurane; Pediatric anesthesia

Outcome Measures

Primary Outcomes (1)

• Emergence delirium

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

  From end of gas administration up to 2 hours after surgery

Secondary Outcomes (4)

• Pain

  From end of gas administration up to 2 hours after surgery

• Bispectral Index

  From start of induction until end of surgery

• Heart rate

  From start of induction until end of surgery

• Blood pressure

  From start of induction until end of surgery

Study Arms (2)

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.

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.

Other: Sevoflurane 5%

Interventions

Sevoflurane 8% OTHER

Sevoflurane 8% (high dose) during anesthesia induction

Also known as: Sevorane

High dose sevoflurane

Sevoflurane 5% OTHER

Sevoflurane 5% (low dose) during anesthesia induction

Also known as: Sevorane

Low dose sevoflurane

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Surgery with caudal block: circumcision (phimosis), hernioplasty (inguinal hernia)
• American Society of Anesthesiologists (ASA) classification of I or II

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

División de Anestesia - Facultad de Medicina Pontificia Universidad Católica

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

Related Publications (23)

• 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.

  PMID: 20497353 BACKGROUND

• Li 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.

  PMID: 25669611 BACKGROUND

• Oofuvong 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.

  PMID: 24428097 BACKGROUND

• Sikich 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.

  PMID: 15114210 BACKGROUND

• Ozcan 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.

  PMID: 25437692 BACKGROUND

• Saxena 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.

  PMID: 25624536 BACKGROUND

• Abdel-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.

  PMID: 25643510 BACKGROUND

• Zhang 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.

  PMID: 24932765 BACKGROUND

• Costi 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.

  PMID: 25212274 BACKGROUND

• Dahmani 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.

  PMID: 24784918 BACKGROUND

• Gibert 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.

  PMID: 23103557 BACKGROUND

• Schultz 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.

  PMID: 22829896 BACKGROUND

• Kreuzer 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.

  PMID: 24586585 BACKGROUND

• Pilge 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.

  PMID: 23221897 BACKGROUND

• Julliac 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.

  PMID: 24035611 BACKGROUND

• Hadi SM, Saleh AJ, Tang YZ, Daoud A, Mei X, Ouyang W. The effect of KETODEX on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane based-anesthesia. Int J Pediatr Otorhinolaryngol. 2015 May;79(5):671-6. doi: 10.1016/j.ijporl.2015.02.012. Epub 2015 Feb 19.

  PMID: 25770644 BACKGROUND

• Adachi M, Ikemoto Y, Kubo K, Takuma C. Seizure-like movements during induction of anaesthesia with sevoflurane. Br J Anaesth. 1992 Feb;68(2):214-5. doi: 10.1093/bja/68.2.214.

  PMID: 1540467 BACKGROUND

• Vakkuri A, Yli-Hankala A, Sarkela M, Lindgren L, Mennander S, Korttila K, Saarnivaara L, Jantti V. Sevoflurane mask induction of anaesthesia is associated with epileptiform EEG in children. Acta Anaesthesiol Scand. 2001 Aug;45(7):805-11. doi: 10.1034/j.1399-6576.2001.045007805.x.

  PMID: 11472278 BACKGROUND

• Yli-Hankala A, Vakkuri A, Sarkela M, Lindgren L, Korttila K, Jantti V. Epileptiform electroencephalogram during mask induction of anesthesia with sevoflurane. Anesthesiology. 1999 Dec;91(6):1596-603. doi: 10.1097/00000542-199912000-00009.

  PMID: 10598599 BACKGROUND

• Vakkuri A, Jantti V, Sarkela M, Lindgren L, Korttila K, Yli-Hankala A. Epileptiform EEG during sevoflurane mask induction: effect of delaying the onset of hyperventilation. Acta Anaesthesiol Scand. 2000 Jul;44(6):713-9. doi: 10.1034/j.1399-6576.2000.440609.x.

  PMID: 10903015 BACKGROUND

• Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.

  PMID: 12760985 BACKGROUND

• Aouad MT, Kanazi GE, Siddik-Sayyid SM, Gerges FJ, Rizk LB, Baraka AS. Preoperative caudal block prevents emergence agitation in children following sevoflurane anesthesia. Acta Anaesthesiol Scand. 2005 Mar;49(3):300-4. doi: 10.1111/j.1399-6576.2005.00642.x.

  PMID: 15752392 BACKGROUND

• Welborn LG, Hannallah RS, Norden JM, Ruttimann UE, Callan CM. Comparison of emergence and recovery characteristics of sevoflurane, desflurane, and halothane in pediatric ambulatory patients. Anesth Analg. 1996 Nov;83(5):917-20. doi: 10.1097/00000539-199611000-00005.

  PMID: 8895263 BACKGROUND

MeSH Terms

Conditions

Delirium; Emergence Delirium

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Nicolas Aeschlimann, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Aeschlimann, MD

CONTACT

+56 2 2354 3415; nicolas@med.puc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 11, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 11, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)