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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University College Cork
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Dr Paul Brady, University College Cork
ClinicalTrials.gov Identifier:
NCT01949012
First received: September 9, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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 Intervention
Hypoxemia
Other: Capnography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by University College Cork:

Primary Outcome Measures:
  • Arterial oxygen desaturation (SpO2 < 95%) [ Time Frame: "participants will be followed for the duration of their sedation appointment, an expected average of one hour" ] [ Designated as safety issue: Yes ]
    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:
  • Degree of hypoxemia [ Time Frame: "participants will be followed for the duration of their sedation appointment, an expected average of one hour ] [ Designated as safety issue: Yes ]
    Degree of hypoxemia; Normal (95% and above) Mild (93% to 94.99%), Moderate (90% to 92.99%) Severe hypoxemia (< 90%)


Estimated Enrollment: 210
Study Start Date: October 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Standard monitoring
Experimental: Capnography
Standard monitoring and capnography
Other: Capnography
Capnography waveform and capnometry readings

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949012

Contacts
Contact: Paul Brady, BDS +353 86 8353345 paul.brady@ucc.ie

Locations
Ireland
University College Cork Recruiting
Cork, County Cork, Ireland
Contact: Paul Brady, BDS         
Principal Investigator: Paul Brady, BDS, MFDS, MSc Con Sed         
Sponsors and Collaborators
University College Cork
Covidien
Investigators
Principal Investigator: Paul Brady, BDS MFDs University College Cork
  More Information

Publications:

Responsible Party: Dr Paul Brady, Clinical Fellow, University College Cork
ClinicalTrials.gov Identifier: NCT01949012     History of Changes
Other Study ID Numbers: Dental capnog
Study First Received: September 9, 2013
Last Updated: January 29, 2014
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Cork:
Midazolam
Endtidal carbon dioxide
Desaturation

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

ClinicalTrials.gov processed this record on September 18, 2014