Capnographic Monitoring of Propofol-sedation During Colonoscopy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01638793

Enrollment

528

Registered

2012-07-12

Start date

2012-06-30

Completion date

2013-09-30

Last updated

2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia

Brief summary

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.

Interventions

DEVICEMicrocap (Oridion, Needham, MA, USA)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Severe Hypoxia (SO2 <85%)	—	Evaluate events of severe hypoxia (SO2 \< 85%) in group 1 (capnographic monitoring) as compared to group 2 (oxymetric monitoring)
Time to hypoxia	—	Evaluate the time difference between abnormal ventilation shown on capnography machine and hypoxemia.
Hypoxia in relation to sedation	—	Compare events of hypoxemia and severe hypoxemia during sedation with propofol only as compared to propofol/ketamin combination sedation.
Vegetative Symptoms	—	Evaluate vegetative events (hypotension, hypertension, bradycardia, tachycardia, tachypnea, bradypnea) in both groups during the two sedation forms

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026