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Role of Respiratory Rate Derived From Capnography in Sedated Patients

NCT ID: NCT05793658

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-25

Study Completion Date

2023-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Sedation Problems

Keywords

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Sedation capnography Respiratory rate colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Study Groups

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Sedation with standard capnography

37 patient Sedation using midazolam + propofol for colonoscopy

Group Type ACTIVE_COMPARATOR

Standard capnography

Intervention Type 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.

Sedation with modified capnography

37 patients in Sedation using midazolam + fentanyl + propofol for colonoscopy

Group Type ACTIVE_COMPARATOR

Modified capnography

Intervention Type 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

Interventions

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Standard capnography

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.

Intervention Type PROCEDURE

Modified capnography

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

Intervention Type PROCEDURE

Other Intervention Names

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Qualitative capnograpyhy Quantitative capnography

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al Jedaani Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Al Jedaani group of hospitals

Jeddah, Meccah, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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1/5/22

Identifier Type: -

Identifier Source: org_study_id