Sedation ProblemsNCT05793658
Role of Respiratory Rate Derived From Capnography in Sedated Patients
A study testing Standard capnography and Modified capnography in people with Sedation Problems, run by Al Jedaani Hospital at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sedation Problems
- What is being tested?
- Standard capnography and Modified capnography
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Nov 2022to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA 1 and 2 adult patients
- Age from 20 to 50 years old
- elective colonoscopy
Who cannot join
- American Society of Anesthesiologists (ASA) above Class II
- History of psychiatric or neurological disease
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Al Jedaani group of hospitals
Jeddah, Meccah, 21462/7500
About this study
Official title: 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.
- Conditions
- Sedation Problems
- Being tested
- Standard capnography, Modified capnography
- Keywords
- Sedation, capnography, Respiratory rate, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard capnographyProcedure or surgery
Also called Qualitative capnograpyhy
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 capnographyProcedure or surgery
Also called Quantitative 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
| Study group | Role | What they receive |
|---|---|---|
| Sedation with standard capnography | Active comparator | 37 patient Sedation using midazolam + propofol for colonoscopy Receives: Procedure: Standard capnography |
| Sedation with modified capnography | Active comparator | 37 patients in Sedation using midazolam + fentanyl + propofol for colonoscopy Receives: Procedure: Modified capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Detected by pulse oximeter
Measured: 1 hours
Secondary outcomes (4)
Patient movements during the procedure
Measured by questionnaire to the gastroenterologist (scale from 1 to 5)
Measured: 1 hour
Effort exerted by the anesthesiologist ( the provider)
Measured by questionnaire ( scale from 1 to 5 )
Measured: 1 hour
Patient satisfaction
Measured by questionnaire ( scale from 1 to 5 )
Measured: 1 hour
Gastroenterologist satisfaction
Measured by questionnaire ( scale from 1 to 5 )
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start25 Nov 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Jedaani Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793658
- Sponsor's protocol ID
- 1/5/22
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Respiratory Rate Derived From Capnography Can Prevent Adverse Events Occurred in Sedated Patients.
- ClinicalTrials.gov ID
- NCT05793658
- Acronym / sponsor ID
- 1/5/22
- Conditions
- Sedation Problems
- Keywords
- Sedation, capnography, Respiratory rate, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Al Jedaani HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation with standard capnography | Active comparator | Procedure: Standard capnography37 patient Sedation using midazolam + propofol for colonoscopy |
| Sedation with modified capnography | Active comparator | Procedure: Modified capnography37 patients in Sedation using midazolam + fentanyl + propofol for colonoscopy |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA 1 and 2 adult patients
- Age from 20 to 50 years old
- elective colonoscopy
Key exclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) above Class II
- History of psychiatric or neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard capnographyAlso: Qualitative capnograpyhyPatients 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. | Procedure or surgery | Sedation with standard capnography |
| Modified capnographyAlso: Quantitative capnographyIf 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 | Procedure or surgery | Sedation with modified capnography |
Primary outcome
Hypoxemia
Time frame: 1 hours
Detected by pulse oximeter
4 secondary outcomes
Patient movements during the procedure
Time frame: 1 hour
Effort exerted by the anesthesiologist ( the provider)
Time frame: 1 hour
Patient satisfaction
Time frame: 1 hour
Gastroenterologist satisfaction
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard capnography and Modified capnography in people with Sedation Problems, run by Al Jedaani Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: 1 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.