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

NCT01949012 | Completed DMC

• 1 other identifier: Dental capnog
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Keywords

Midazolam; Endtidal carbon dioxide; Desaturation

Outcome Measures

Primary Outcomes (1)

• Arterial oxygen desaturation (SpO2 < 95%)

  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.

  "participants will be followed for the duration of their sedation appointment, an expected average of one hour"

Secondary Outcomes (1)

• Degree of hypoxemia

  "participants will be followed for the duration of their sedation appointment, an expected average of one hour

Study Arms (2)

Control

NO INTERVENTION

Standard monitoring

Capnography

EXPERIMENTAL

Standard monitoring and capnography

Other: Capnography

Interventions

Capnography OTHER

Capnography waveform and capnometry readings

Capnography

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College Cork: lead
• Medtronic - MITG: collaborator

Study Sites (1)

University College Cork

Cork, County Cork, Ireland

Location

Related Publications (13)

• 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).

  BACKGROUND

• 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)

  BACKGROUND

• standards for dental professionals. U.K. general dental council (2005).

  BACKGROUND

• conscious sedation in dentistry: the competent graduate: dental sedation teachers group(2000).

  BACKGROUND

• 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)

  BACKGROUND

• Beitz A, Riphaus A, Meining A, Kronshage T, Geist C, Wagenpfeil S, Weber A, Jung A, Bajbouj M, Pox C, Schneider G, Schmid RM, Wehrmann T, von Delius S. Capnographic monitoring reduces the incidence of arterial oxygen desaturation and hypoxemia during propofol sedation for colonoscopy: a randomized, controlled study (ColoCap Study). Am J Gastroenterol. 2012 Aug;107(8):1205-12. doi: 10.1038/ajg.2012.136. Epub 2012 May 29.

  PMID: 22641306 BACKGROUND

• Deitch K, Miner J, Chudnofsky CR, Dominici P, Latta D. Does end tidal CO2 monitoring during emergency department procedural sedation and analgesia with propofol decrease the incidence of hypoxic events? A randomized, controlled trial. Ann Emerg Med. 2010 Mar;55(3):258-64. doi: 10.1016/j.annemergmed.2009.07.030. Epub 2009 Sep 24.

  PMID: 19783324 BACKGROUND

• Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.

  PMID: 19422079 BACKGROUND

• Hart LS, Berns SD, Houck CS, Boenning DA. The value of end-tidal CO2 monitoring when comparing three methods of conscious sedation for children undergoing painful procedures in the emergency department. Pediatr Emerg Care. 1997 Jun;13(3):189-93. doi: 10.1097/00006565-199706000-00004.

  PMID: 9220504 BACKGROUND

• Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.

  PMID: 12024135 BACKGROUND

• Tobias JD. End-tidal carbon dioxide monitoring during sedation with a combination of midazolam and ketamine for children undergoing painful, invasive procedures. Pediatr Emerg Care. 1999 Jun;15(3):173-5. doi: 10.1097/00006565-199906000-00002.

  PMID: 10389951 BACKGROUND

• Sivilotti ML, Messenger DW, van Vlymen J, Dungey PE, Murray HE. A comparative evaluation of capnometry versus pulse oximetry during procedural sedation and analgesia on room air. CJEM. 2010 Sep;12(5):397-404. doi: 10.1017/s1481803500012549.

  PMID: 20880431 BACKGROUND

• Miner JR, Heegaard W, Plummer D. End-tidal carbon dioxide monitoring during procedural sedation. Acad Emerg Med. 2002 Apr;9(4):275-80. doi: 10.1111/j.1553-2712.2002.tb01318.x.

  PMID: 11927449 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Brady, BDS MFDs

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 24, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 3, 2016

Record last verified: 2015-05

Locations

IE (1)