Role of Respiratory Rate Derived From Capnography in Sedated Patients

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

Study Overview

• Status: Completed
• Conditions: Sedation Problems
• Intervention / Treatment: Procedure: Standard capnography; Procedure: Modified capnography

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Meccah
    • Jeddah, Meccah, Saudi Arabia, 21462/7500
      • Al Jedaani group of hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxemia	Detected by pulse oximeter	1 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient movements during the procedure	Measured by questionnaire to the gastroenterologist (scale from 1 to 5)	1 hour
Effort exerted by the anesthesiologist ( the provider)	Measured by questionnaire ( scale from 1 to 5 )	1 hour
Patient satisfaction	Measured by questionnaire ( scale from 1 to 5 )	1 hour
Gastroenterologist satisfaction	Measured by questionnaire ( scale from 1 to 5 )	1 hour

Collaborators and Investigators

• Sponsor: Al Jedaani Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: capnography; colonoscopy; Sedation; Respiratory rate
• Other Study ID Numbers: 1/5/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No