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

Delirium Clinical Trial

Official title:

Emergence Delirium in Children: a Randomized Clinical Trial of Different Doses of Sevoflurane During Induction of Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02707016
• Other study ID #: 15-153
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2016
• Last updated: March 7, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Pontificia Universidad Catolica de Chile
• Contact: Nicolas Aeschlimann, MD
• Phone: +56 2 2354 3415
• Email: nicolas[@]med.puc.cl
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical 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.

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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 7 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• Sevoflurane 8%
Sevoflurane 8% (high dose) during anesthesia induction
• Sevoflurane 5%
Sevoflurane 5% (low dose) during anesthesia induction

Locations

Country	Name	City	State
Chile	División de Anestesia - Facultad de Medicina Pontificia Universidad Católica	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;9:CD007084. doi: 10.1002/14651858.CD007084.pub2. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. — View Citation

Vakkuri A, Jantti V, Särkelä 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. — View Citation

Vakkuri A, Yli-Hankala A, Särkelä M, Lindgren L, Mennander S, Korttila K, Saarnivaara L, Jäntti V. Sevoflurane mask induction of anaesthesia is associated with epileptiform EEG in children. Acta Anaesthesiol Scand. 2001 Aug;45(7):805-11. — View Citation

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):1625-30, table of contents. — View Citation

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. — View Citation

Yli-Hankala A, Vakkuri A, Särkelä M, Lindgren L, Korttila K, Jäntti V. Epileptiform electroencephalogram during mask induction of anesthesia with sevoflurane. Anesthesiology. 1999 Dec;91(6):1596-603. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	From end of gas administration up to 2 hours after surgery	Yes
Secondary	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	From start of induction until end of surgery	Yes
Secondary	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	From start of induction until end of surgery	Yes
Secondary	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	From start of induction until end of surgery	Yes