Role of Respiratory Rate Derived From Capnography in Sedated Patients

Sponsor

Al Jedaani Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05793658

Collaborator

(none)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

25.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sedation Problems	Procedure: Standard capnography Procedure: Modified capnography	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 25, 2022

Actual Primary Completion Date :

Feb 20, 2023

Actual Study Completion Date :

Feb 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sedation with standard capnography 37 patient Sedation using midazolam + propofol for colonoscopy	Procedure: 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. Other Names: Qualitative capnograpyhy
Active Comparator: Sedation with modified capnography 37 patients in Sedation using midazolam + fentanyl + propofol for colonoscopy	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 Other Names: Quantitative capnography

Arm

Intervention/Treatment

Active Comparator: Sedation with standard capnography

37 patient Sedation using midazolam + propofol for colonoscopy

Procedure: 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.

Other Names:

Qualitative capnograpyhy

Active Comparator: Sedation with modified capnography

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

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

Other Names:

Quantitative capnography

Outcome Measures

Primary Outcome Measures

Hypoxemia [1 hours]
Detected by pulse oximeter

Secondary Outcome Measures

Patient movements during the procedure [1 hour]
Measured by questionnaire to the gastroenterologist (scale from 1 to 5)
Effort exerted by the anesthesiologist ( the provider) [1 hour]
Measured by questionnaire ( scale from 1 to 5 )
Patient satisfaction [1 hour]
Measured by questionnaire ( scale from 1 to 5 )
Gastroenterologist satisfaction [1 hour]
Measured by questionnaire ( scale from 1 to 5 )

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Jedaani group of hospitals	Jeddah	Meccah	Saudi Arabia	21462/7500

Sponsors and Collaborators

Al Jedaani Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Al Jedaani Hospital

ClinicalTrials.gov Identifier:

NCT05793658

Other Study ID Numbers:

1/5/22

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Al Jedaani Hospital

Study Results

No Results Posted as of Mar 31, 2023