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Postoperative Discomfort After Dental General Anesthesia

NCT03197753 — Not applicable, Completed, 70 participants, Aydin Adnan Menderes University

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Postoperative Discomfort and Emergence Delirium In Children Receiving Dental Treatment Under General Anesthesia: Comparison Of Nasal Tracheal Intubation and Laryngeal Mask Airway

RegistryNCT03197753
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment70 (Actual)
SponsorAydin Adnan Menderes University (Other)
ConditionsPostoperative Pain
InterventionsLaryngeal mask airway, Nasotracheal intubation (Device)
Datesstart 2017-06-15, primary completion 2017-08-01, completion 2017-08-04, first posted 2017-06-23, last updated 2017-08-17
Locations1 site in Turkey (Türkiye)

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-Summary

The aim of this prospective, randomised, controlled clinical trial was to compare immediate postoperative discomfort, emergence delirium and recovery time of the patients intubated using either laryngeal mask airway or nasotracheal intubation.

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+Detailed description

A total of 70 children aged 3 to 7 years received full mouth dental rehabilitation under general anesthesia. Children were randomly grouped into Laryngeal mask airway (LMA) group (n=35) and nasotracheal intubation (NTI) groups (n=35). In LMA group LMA was inserted after anesthesia induction using 8% sevoflurane. In NTI group rocuronium and remifentanil were given intravenously during %8 sevoflurane induction and the patients were intubated by a nasotracheal tube. After completion of the dental treatments patients were transferred to the post anesthesia care unit (PACU). Duration of dental operation ,duration of anesthesia, recovery time, postoperative discomfort, emergence delirium, pediatric dentist's access were recorded.

+Arms and interventions

ArmTypeInterventionsDescription
Laryngeal mask airwayExperimentalDevice: Laryngeal mask airwayLaryngeal mask airway insertion
Nasotracheal intubationActive comparatorDevice: Nasotracheal intubationNasotracheal tube insertion
  • Laryngeal mask airway (Device): Laryngeal mask airway
  • Nasotracheal intubation (Device): Nasotracheal intubation

+Outcome measures

Primary outcomes

  • Postoperative discomfort [Postoperative 1 hour]: Sore throat

+Eligibility

Sex: All, ages: 3 Years to 7 Years, accepts healthy volunteers

Inclusion Criteria:

* Aged 3-7 years,
* ASA I and II
* Lack of chairside cooperation for dental treatment in clinical setting.

Exclusion Criteria:

* A history of of anticipated difficult entubation ,
* Patient with pharyngeal pathology patients with known pulmonory or cardiovascular disease,
* When the expected dental procedure was more than two hours
* Mental retardation and those whose parents did not consent to their participation in the study.

+Locations (1)

FacilityCityCountryStatus
Sultan KelesAydin, EfelerTurkey (Türkiye)

+Publications

  • Hung WT, Chen CC, Chau MY, Tsai WY. Effect of reinforced laryngeal mask airway or endotracheal intubation anesthesia on adverse events: quality of life issues for dental patients requiring general sedation. Spec Care Dentist. 2005 Jul-Aug;25(4):188-92. doi: 10.1111/j.1754-4505.2005.tb01648.x. PMID 16295223
  • Zhao N, Deng F, Yu C. Anesthesia for pediatric day-case dental surgery: a study comparing the classic laryngeal mask airway with nasal trachea intubation. J Craniofac Surg. 2014 May;25(3):e245-8. doi: 10.1097/SCS.0000000000000547. PMID 24820727

+Investigators

  • Sultan KELES, Dr., Principal investigator, Aydin Adnan Menderes University

My Notes