Conscious Sedation Failure During ProcedureNCT02820051
Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy
A study testing Transcutaneous CO2 monitor, Midazolam and Propofol in people with Conscious Sedation Failure During Procedure, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of respiratory diseases. Although midazolam is the recommended sedative agent by most guidelines, propofol has gained popularity due a short recovery time, however, evidence to propofol use for sedation during FB is scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conscious Sedation Failure During Procedure
- What is being tested?
- Transcutaneous CO2 monitor, Midazolam and Propofol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory patients aged > 18 years with an indication for flexible bronchoscopy.
Who cannot join
- tracheostomy
- known allergy to drugs used during procedural sedation
- inability to answer the satisfaction questionnaires
- psychiatric illness, pregnancy
- ASA class IV or V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-anesthesiologist-administered Propofol is Not Related to a Higher Increase in Transcutaneous CO2 Pressure During the Flexible Bronchoscopy Compared to Guideline-based Sedation: A Randomized Controlled Trial
Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of respiratory diseases. Although midazolam is the recommended sedative agent by most guidelines, propofol has gained popularity due a short recovery time, however, evidence to propofol use for sedation during FB is scarce. There is little evidence about transcutaneous CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough inhibition.
The investigators performed a randomized controlled trial to determine whether non-anesthesiology-administered balanced-sedation with propofol was related to high values of values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The investigators included data from outpatients 18 years or older with an indication for FB in a university hospital in northern of Mexico. Secondary outcomes were recuperation time, patient satisfaction and adverse effects.
Read the detailed description
The investigators prospectively included ambulatory patients aged > 18 years with an indication for flexible bronchoscopy. Bronchoscopic procedures were performed by residents of Respiratory and Critical Care Medicine subspecialty under the supervision of an attendant professor in a university-tertiary-referral center in northern Mexico. Patients with tracheostomy, known allergy to drugs used during procedural sedation, inability to answer the satisfaction questionnaires, psychiatric illness, pregnancy, or with ASA class IV or V, were excluded.
Patients were randomly assigned to receive sedation with midazolam or propofol. In the group of midazolam the initial dose was 0.05 mg/kg and in propofol group, the starting dose was 0.1 mg /kg. Additional doses of the corresponding drug (2 mg of midazolam or 10 mg of propofol) were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Prior to insertion of the bronchoscope, lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nasal insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.
In both groups, transcutaneous CO2 measurement was carried out with the system SenTec digital monitoring (Artemis Medical, Kent, London) by applying a Stow-Severinghaus (V-Sign sensor) type sensor in the ear lobe. All patients received supplementary oxygen and were monitored with intermittent non-invasive blood pressure measurements every 3 min and with continuous EKG and SO2 surveillance.
The assessment of the state of residual sedation was performed with the Aldrete scale at five, 10 and 15 minutes after complete FB. At the time of discharge from the bronchoscopy suite, a satisfaction questionnaire was applied to patients.
Sedation and analgesia were prescribed by the resident responsible for conducting FB without the support of specialists in anesthesiology. One collaborator blinded to the study group to which each patient belonged recorded all data derived from the procedure. The Bronchoscopist was blinded to PtcCO2 values.
- Keywords
- bronchoscopy, conscious sedation, midazolam, patient comfort, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous CO2 monitorDevice
Also called SenTec digital monitoring and Stow-Severinghaus type sensor
Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group.
MidazolamDrug
Also called Dormicum
The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale.
PropofolDrug
Also called Diprivan
The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale.
NalbuphineDrug
Also called Nubain
The starting dose was 2 mg with additional doses of 1 mg if it was necessary.
LidocaineDrug
Also called Xylocaine
Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Active comparator | In the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.
Intervention: Transcutaneous CO2 monitor Receives: Device: Transcutaneous CO2 monitor; Drug: Midazolam; Drug: Nalbuphine; Drug: Lidocaine |
| Propofol | Experimental | In the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.
Intervention: Transcutaneous CO2 monitor Receives: Device: Transcutaneous CO2 monitor; Drug: Propofol; Drug: Nalbuphine; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Transcutaneous CO2 Pressure
Our primary outcome was to assess the difference in PtCO2 values during and after FB between the groups. We hypothesized that PtcO2 values are not higher in patients who received NAAP balanced sedation.
Measured: Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60
Secondary outcomes (2)
Residual Sedation Assessed Using the Aldrete Scale
The assessment of the state of residual sedation was performed with the Aldrete scale at minute 30 after complete bronchoscopy.
The Aldrete's scoring system is a commonly used scale for determining when people can be safely discharged from the post-anesthesia care unit. The Minumum value is 0 points and the maximum value is 10 pots. Scores of 9 or greater allow patients to leave Post Anaesthetic Care Unit.
Measured: 30 min after ending of the bronchoscopy
Patient Comfort Assessed Using a Satisfaction Questionnaire
At the time of discharge from the bronchoscopy suite, satisfaction was assessed using a visual analog scale of 1 (not satisfied) to 10 (very satisfied).
Measured: at discharge from bronchoscopy suite, average 60 min from FB start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conscious Sedation Failure During ProcedureStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Edgardo González Aguirre, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Roberto Mercado, MD, Study chair, UANL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820051
- Sponsor's protocol ID
- NM13-009
- Status last verified
- Oct 2024
- First submitted
- 22 Jun 2016
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mercado-Longoria R, Armeaga-Azonos C, Tapia-Orozco J, Gonzalez-Aguirre JE. Non-anesthesiologist-administered Propofol is not Related to an Increase in Transcutaneous CO2 Pressure During Flexible Bronchoscopy Compared to Guideline-based Sedation: A Randomized Controlled Trial. Arch Bronconeumol. 2017 Sep;53(9):489-494. doi: 10.1016/j.arbres.2016.12.018. Epub 2017 Apr 12. English, Spanish.
PubMed 28410767
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-anesthesiologist-administered Propofol is Not Related to a Higher Increase in Transcutaneous CO2 Pressure During the Flexible Bronchoscopy Compared to Guideline-based Sedation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02820051
- Acronym / sponsor ID
- NM13-009
- Keywords
- bronchoscopy, conscious sedation, midazolam, patient comfort, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of respiratory diseases. Although midazolam is the recommended sedative agent by most guidelines, propofol has gained popularity due a short recovery time, however, evidence to propofol use for sedation during FB is scarce. There is little evidence about transcutaneous CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough inhibition.
The investigators performed a randomized controlled trial to determine whether non-anesthesiology-administered balanced-sedation with propofol was related to high values of values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The investigators included data from outpatients 18 years or older with an indication for FB in a university hospital in northern of Mexico. Secondary outcomes were recuperation time, patient satisfaction and adverse effects.
Detailed description
The investigators prospectively included ambulatory patients aged > 18 years with an indication for flexible bronchoscopy. Bronchoscopic procedures were performed by residents of Respiratory and Critical Care Medicine subspecialty under the supervision of an attendant professor in a university-tertiary-referral center in northern Mexico. Patients with tracheostomy, known allergy to drugs used during procedural sedation, inability to answer the satisfaction questionnaires, psychiatric illness, pregnancy, or with ASA class IV or V, were excluded.
Patients were randomly assigned to receive sedation with midazolam or propofol. In the group of midazolam the initial dose was 0.05 mg/kg and in propofol group, the starting dose was 0.1 mg /kg. Additional doses of the corresponding drug (2 mg of midazolam or 10 mg of propofol) were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Prior to insertion of the bronchoscope, lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nasal insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.
In both groups, transcutaneous CO2 measurement was carried out with the system SenTec digital monitoring (Artemis Medical, Kent, London) by applying a Stow-Severinghaus (V-Sign sensor) type sensor in the ear lobe. All patients received supplementary oxygen and were monitored with intermittent non-invasive blood pressure measurements every 3 min and with continuous EKG and SO2 surveillance.
The assessment of the state of residual sedation was performed with the Aldrete scale at five, 10 and 15 minutes after complete FB. At the time of discharge from the bronchoscopy suite, a satisfaction questionnaire was applied to patients.
Sedation and analgesia were prescribed by the resident responsible for conducting FB without the support of specialists in anesthesiology. One collaborator blinded to the study group to which each patient belonged recorded all data derived from the procedure. The Bronchoscopist was blinded to PtcCO2 values.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Active comparator | Device: Transcutaneous CO2 monitor, Drug: Midazolam, Drug: Nalbuphine, Drug: LidocaineIn the group of midazolam, the initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor |
| Propofol | Experimental | Device: Transcutaneous CO2 monitor, Drug: Propofol, Drug: Nalbuphine, Drug: LidocaineIn the group of propofol, the starting dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of 3 to 4 in the Observer´s assessment of alertness/ sedation scale. All patients received nalbuphine in a starting dose of 2 mg with additional doses of 1 mg if it was necessary. Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. Intervention: Transcutaneous CO2 monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ambulatory patients aged > 18 years with an indication for flexible bronchoscopy.
Key exclusion criteria (5 listed)
- tracheostomy
- known allergy to drugs used during procedural sedation
- inability to answer the satisfaction questionnaires
- psychiatric illness, pregnancy
- ASA class IV or V
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 |
|---|---|---|
| Transcutaneous CO2 monitorAlso: SenTec digital monitoring and Stow-Severinghaus type sensorMeasurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group. | Device | Midazolam, Propofol |
| MidazolamAlso: DormicumThe initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. | Drug | Midazolam |
| PropofolAlso: DiprivanThe initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale. | Drug | Propofol |
| NalbuphineAlso: NubainThe starting dose was 2 mg with additional doses of 1 mg if it was necessary. | Drug | Midazolam, Propofol |
| LidocaineAlso: XylocaineLidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg. | Drug | Midazolam, Propofol |
Primary outcome
Change in Transcutaneous CO2 Pressure
Time frame: Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60
Our primary outcome was to assess the difference in PtCO2 values during and after FB between the groups. We hypothesized that PtcO2 values are not higher in patients who received NAAP balanced sedation.
2 secondary outcomes
Residual Sedation Assessed Using the Aldrete Scale
Time frame: 30 min after ending of the bronchoscopy
Patient Comfort Assessed Using a Satisfaction Questionnaire
Time frame: at discharge from bronchoscopy suite, average 60 min from FB start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28410767Mercado-Longoria R, Armeaga-Azonos C, Tapia-Orozco J, Gonzalez-Aguirre JE. Non-anesthesiologist-administered Propofol is not Related to an Increase in Transcutaneous CO2 Pressure During Flexible Bronchoscopy Compared to Guideline-based Sedation: A Randomized Controlled Trial. Arch Bronconeumol. 2017 Sep;53(9):489-494. doi: 10.1016/j.arbres.2016.12.018. Epub 2017 Apr 12. English, Spanish.
- Individual participant dataSharing planned: No
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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.
Roberto Mercado, MD study chair
UANL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous CO2 monitor, Midazolam and Propofol in people with Conscious Sedation Failure During Procedure, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 1 inclusion and 5 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 2 Dec 2024. 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 Mexico. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Transcutaneous CO2 Pressure (time frame: Change from Baseline PtcCO2 (minute 0) to PtcCO2 at minute 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820051, which also lists 1 linked publication.
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 2 Dec 2024.