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NCT Number: NCT02720705

Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university hospitals

Asyut, Assiut,Egypt,71571, Egypt

About this study

Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors.

Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery.

The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status I-II patients
  • aged 2-6 years
  • patient scheduled for elective tonsillectomy due to recurrent
  • chronic tonsillitis

Exclusion criteria

  • patients with known hypersensitivity to medication drugs
  • coagulation disorders
  • thrombocytopenia
  • significant cardiac
  • renal
  • pulmonary
  • hepatic disease

Treatment and study plan

Dexmedetomidine

Drug

oral dexmedetomidine

Other names: precedex

Saline

Drug

2ml 0.9% saline administered orally half an hour before induction of anesthesia

Other names: 0.9% saline

Primary outcomes

  1. The agitation score up to 1hour postoperative.

    Time frame: first postoperative hour

    Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min.

Secondary outcomes

  1. Pain score assessed using the objective pain scale.

    Time frame: up to 1hour postoperative hour

    Pain intensity will be assessed postoperatively by using the objective pain scale. objective pain scale assessments will be performed in the following time points; at 5 min postoperative, 10 min, 15, 30, 45, 60 min.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Transbucal Dexmedetomidine for the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Pre-school Children

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 28, 2016
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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