Role of Respiratory Rate Derived From Capnography in Sedated Patients

Sedation Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05793658
• Other study ID #: 1/5/22
• Status: Completed
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: March 2023
• Source: Al Jedaani Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation Problems

Intervention

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.
• 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

Locations

Country	Name	City	State
Saudi Arabia	Al Jedaani group of hospitals	Jeddah	Meccah

Sponsors (1)

Lead Sponsor	Collaborator
Al Jedaani Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	Detected by pulse oximeter	1 hours
Secondary	Patient movements during the procedure	Measured by questionnaire to the gastroenterologist (scale from 1 to 5)	1 hour
Secondary	Effort exerted by the anesthesiologist ( the provider)	Measured by questionnaire ( scale from 1 to 5 )	1 hour
Secondary	Patient satisfaction	Measured by questionnaire ( scale from 1 to 5 )	1 hour
Secondary	Gastroenterologist satisfaction	Measured by questionnaire ( scale from 1 to 5 )	1 hour