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Completed

NCT Number: NCT05793658

Role of Respiratory Rate Derived From Capnography in Sedated Patients

Although appropriate sedation is recommended during colonoscopy, patients are at risk for adverse events e.g hypoventilation and hypoxemia due to inadvertent oversedation. The aim of this study was to evaluate the benefit of additional quantitative capnography monitoring ( respiratory rate )in management of patient undergoing colonoscopy under sedation in preventing or reducing the incidence of adverse events and also determine when to start the procedure and when to give and not to give increments of sedative drugs during the procedure.

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Key information

Conditions

Sedation Problems

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Jedaani group of hospitals

Jeddah, Meccah, 21462/7500, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA 1 and 2 adult patients
  • Age from 20 to 50 years old
  • elective colonoscopy

Exclusion criteria

  • American Society of Anesthesiologists (ASA) above Class II
  • History of psychiatric or neurological disease

Treatment and study plan

Standard capnography

Procedure

Patients undergoing colonoscopy under sedation were randomly assigned to receive standard capnography monitoring or modified capnography monitoring which can be achieved by tucking capnography probe under the face mask.74 patients were enrolled. Patient characteristics were well balanced between the two groups 37 patients in each group.

Other names: Qualitative capnograpyhy

Modified capnography

Procedure

If Respiratory rate below 14 b/m: more sedation isn't not advised and the patient may develop airway obstruction and needs airway intervention ( like jaw thrust or oral airway) If respiratory rate more than 20 b/m it means this patient is prone to awake or to move and this patient in need for incremental dose of sedative drug ( e.g 20 to 30 mg propofol) Also roughly speaking respiratory rate from 16 to 18 b/m is the target

Other names: Quantitative capnography

Primary outcomes

  1. Hypoxemia

    Time frame: 1 hours

    Detected by pulse oximeter

Secondary outcomes

  1. Patient movements during the procedure

    Time frame: 1 hour

    Measured by questionnaire to the gastroenterologist (scale from 1 to 5)

  2. Effort exerted by the anesthesiologist ( the provider)

    Time frame: 1 hour

    Measured by questionnaire ( scale from 1 to 5 )

  3. Patient satisfaction

    Time frame: 1 hour

    Measured by questionnaire ( scale from 1 to 5 )

  4. Gastroenterologist satisfaction

    Time frame: 1 hour

    Measured by questionnaire ( scale from 1 to 5 )

Sponsors and collaborators

Lead sponsor

Al Jedaani Hospital

Other

Registry information

Official study title

Is Respiratory Rate Derived From Capnography Can Prevent Adverse Events Occurred in Sedated Patients.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2023
Registry last updated
Mar 31, 2023

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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