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Completed

NCT Number: NCT01638793

Capnographic Monitoring of Propofol-sedation During Colonoscopy

The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum der J. W. Goethe-Universität, Frankfurt am Main, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for colonoscopy
  • Patient wishing sedation during colonoscopy
  • ≥ 18 years of age
  • Signed informed consent form

Exclusion criteria

  • Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
  • Non-contractually capable persons
  • Pregnancy
  • Lactation

Treatment and study plan

Microcap (Oridion, Needham, MA, USA)

Device

Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)

Device

Primary outcomes

  1. Hypoxia (SO2 <90%)

    Study objective is to evaluate if a reduction of hypoxic events (SO2 <90% for ≥ 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation

Secondary outcomes

  1. Severe Hypoxia (SO2 <85%)

    Evaluate events of severe hypoxia (SO2 < 85%) in group 1 (capnographic monitoring) as compared to group 2 (oxymetric monitoring)

  2. Time to hypoxia

    Evaluate the time difference between abnormal ventilation shown on capnography machine and hypoxemia.

  3. Hypoxia in relation to sedation

    Compare events of hypoxemia and severe hypoxemia during sedation with propofol only as compared to propofol/ketamin combination sedation.

  4. Vegetative Symptoms

    Evaluate vegetative events (hypotension, hypertension, bradycardia, tachycardia, tachypnea, bradypnea) in both groups during the two sedation forms

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2012
Registry last updated
Oct 25, 2013

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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