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Completed

NCT Number: NCT00963898

Accurate Controlled Dental Sedation

The aim of this study is to evaluate benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior.

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Key information

Conditions

Mental Retardation Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dental Anesthesiology, Okayama University Hospital

Okayama, Okayama-ken, 700-8525, Japan

About this study

The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants aged 16 or over,
  • American Society of Anesthesiologists (ASA) physical status 1 or 2
  • The treatments of dental caries, endodontics, periodontics and prosthesis were planed
  • Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion criteria

  • Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons,
  • Patients needed premedication
  • Patients had uncontrolled or sever medical condition

Treatment and study plan

Target controlled infusion(TCI), Bispectral index(BIS)

Device

Using TCI and BIS or not

Primary outcomes

  1. The dose of anesthesia agent

    Time frame: 1 day

  2. The recovery times of eyelash reflex and eye opening

    Time frame: 1 day

  3. The time to going home

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Registry information

Official study title

The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation

Acronym: ACDS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 24, 2009
Registry last updated
Aug 24, 2009

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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