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Capnography Monitoring During Intravenous Conscious Sedation Sedation With Midazolam for Oral Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01949012
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : June 3, 2016
Medtronic - MITG
Information provided by (Responsible Party):
Dr Paul Brady, University College Cork

Brief Summary:
Dentists use sedation to help patients accept difficult procedures and to relieve anxiety. During sedation, the well-being of the patient is monitored by the dental team. When carried out according to recognised guidelines,intravenous dental sedation is considered to be very safe. For some patients, dental sedation is a useful alternative to general anaesthetic. It is cheaper and has the potential to be more accessible. Oximetry(measurement of oxygen status) is the current gold standard in dental sedation. The main risk to the patient during sedation is a slowing of breathing due to the effects of the sedative drug. Studies from other settings where sedation is practiced suggest that an additional monitor with capnography facilitates early detection of depressed breathing. However, the results of studies from other medical settings cannot be generalised to dental sedation, because of different techniques used and the types of patients. The depth of sedation may also be vary. For dental sedation, patients remain responsive at all times and breathe for themselves. Capnography gives breath by breath information using a simple device placed close to the nose and mouth. It has been recommended by several governing medical bodies that each area of medicine, should develop its own guidelines for sedation. Therefore, there is a need to research the application of capnography for dental sedation. The proposed study will take place at a university hospital site. Patients will be randomly divided into two groups. Both groups will receive sedation in the normal way. The study group will have capnography monitoring added. The study will look for differences in breathing between the two groups. Additional information regarding other aspects of monitoring will also be obtained. The results from the proposed study may help to improve patient safety and change current practice during sedation for dentistry.

Condition or disease Intervention/treatment
Hypoxemia Other: Capnography

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomised Control Trial to Determine Whether Intervention Based on a Microstream Capnography-based Ventilation Monitoring System Will Decrease Hypoxaemaia During Intravenous Sedation With Midazolam.
Study Start Date : October 2013
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Standard monitoring
Experimental: Capnography
Standard monitoring and capnography
Other: Capnography
Capnography waveform and capnometry readings

Primary Outcome Measures :
  1. Arterial oxygen desaturation (SpO2 < 95%) [ Time Frame: "participants will be followed for the duration of their sedation appointment, an expected average of one hour" ]
    This primary outcome measure was chosen in part because it represents a threshold point for sedation staff to stimulate patients to breathe via tactile or verbal actions.

Secondary Outcome Measures :
  1. Degree of hypoxemia [ Time Frame: "participants will be followed for the duration of their sedation appointment, an expected average of one hour ]
    Degree of hypoxemia; Normal (95% and above) Mild (93% to 94.99%), Moderate (90% to 92.99%) Severe hypoxemia (< 90%)

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. American Society of Anaesthesiologists (ASA) class 1 & 2 only
  2. Age 14years to 65 years
  3. Ability to give written informed consent

Exclusion Criteria:

  1. Inability to give informed consent
  2. Body Mass Index > 35 Kg/M2
  3. Procedure in the upper anterior region of the mouth which prevents placement of the oral - nasal sampling device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01949012

University College Cork
Cork, County Cork, Ireland
Sponsors and Collaborators
University College Cork
Medtronic - MITG
Principal Investigator: Paul Brady, BDS MFDs University College Cork

implementing and ensuring safe sedation practice for healthcare procedures in adults. report of an intercollegiate working party chaired by the royal college of anaesthetists. uk academy of medical royal colleges and their faculties (2001).
conscious sedation in the provision of dental care. report of an expert group on sedation for dentistry. standing dental advisory committee, department of health (2003)
standards for dental professionals. U.K. general dental council (2005).
conscious sedation in dentistry: the competent graduate: dental sedation teachers group(2000).
standards for conscious sedation in dentistry: alternative techniques. a report from the standing committee on sedation for dentistry, faculty of dental surgery of the royal college of surgeons in england (2007)

Responsible Party: Dr Paul Brady, Clinical Fellow, University College Cork Identifier: NCT01949012     History of Changes
Other Study ID Numbers: Dental capnog
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2015

Keywords provided by Dr Paul Brady, University College Cork:
Endtidal carbon dioxide

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action