ColonoscopyNCT03461029
Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
An observational study of Colonoscopy, run by Hospital Galdakao-Usansolo at 1 site in Spain.
Trial summary
The aim of the study is to establish and identify the level of sedation that is performed in the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS monitoring system, which obtains objective values in real time from the anesthesia performed. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- BIS monitor
- Type of treatment
- Medical device
- How many people
- 196 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2016to 20 Feb 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from the general population, residents in the geographical area corresponding to the Hospital Galdakao Usansolo, who attended the endoscopy rooms. Were included to undergo a scheduled colonoscopy, either for monitoring, diagnostic or screening, and to meet the cited inclusion criteria.
Who may be able to join
- Indication of scheduled colonoscopy.
- Classification of physical status ASA I, II and III.
- Intermitent or persistent mild asthma.
- Body Mass Index (BMI) < 35 kg/m2.
- Intact neurological capacity.
- Acceptance to participate in the study after signing written informed consent.
Who cannot join
- ASA IV.
- BMI > 35 kg/m2.
- Allergy to any of the medications using in sedation, or its components.
- Known mental or neurological disease.
- Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sleep Apnea.
- Chronic opiate users.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to establish and identify the level of sedation that is performed in the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS monitoring system, which obtains objective values in real time from the anesthesia performed. The monitoring is completed with basic parameters validated by European guidelines (heart rate, blood pressure, oxygen saturation and respiratory rate), capnography and Ramsay sedation scale, widely validated for use outside the operating room. The main work hypothesis was that in at least 10% of the patients BIS values compatible with moderate or deep sedation would be obtained (BIS <65).
Read the detailed description
Observational study in patients undergoing scheduled colonoscopy in endoscopy rooms of the Galdakao-Usansolo Hospital. The investigators objectified the level of sedation that was performed in these procedures using Bispectral Index Monitoring, as well as the total dose of medication required and the level of satisfaction obtained after completing the sedation. The incidence of hemodynamic and respiratory complications observed was included, as well as the treatment needed to solve them.
A total of 196 patients were needed to obtain statistically significant results. Qualitative variables are expressed in the form of freguencies and percentages and continuous variables in the form of means and stnadard deviations. Comparisions of percentages were made by the Chi square test and the difference of means in the continuous variables by the t test.Stadistical significance will be assumed when p<0.05. All estadistical analyzes were carried out using SAS V9.4 (SAS Institute, Inc., Carey, NC).
- Conditions
- Colonoscopy
- Being tested
- BIS monitor
- Keywords
- Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS monitorDevice
The investigators placed on the forehead of all patients the sensor BIS quatroTM, that connects with the monitor, and they registered sedation and recorded the values obtained.
| Study group | Role | What they receive |
|---|---|---|
| BIS | Group of 196 patients in whom sedation monitoring is performed using the Bispectral Index Monitoring (BIS) system. Receives: Device: BIS monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of sedation
Sedation measured by Bispectral Index Monitoring.
Measured: 1 year.
Secondary outcomes (2)
Complications related to sedation.
Complications were measured: hypotension, bradicardia, apnea and low oxygen saturation. The medications or maneuvers that were necessary to correct these complications were also evaluated.
Measured: 1 year.
Level of satisfaction with the sedation.
The investigators distributed a satisfaction questionnaire to all patients after colonoscopy to find their opinion about the quality of sedation.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start30 Jan 2016
- Primary completion30 Dec 2017
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 196 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Iratxe González Mendibil, Hospital Galdakao-Usansolo
- Investigators
- Iratxe Gonzalez Mendibil, MD, Principal investigator, Hospital Galdakao-Usansolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461029
- Sponsor's protocol ID
- 01/16
- Status last verified
- Feb 2018
- First submitted
- 5 Mar 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The information contained in the study will be published once the review of the data included in it is completed. Previously, researchers will decide if the information contained is relevant for publication on this platform.
Publications
Dumonceau JM, Riphaus A, Schreiber F, Vilmann P, Beilenhoff U, Aparicio JR, Vargo JJ, Manolaraki M, Wientjes C, Racz I, Hassan C, Paspatis G. Non-anesthesiologist administration of propofol for gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates Guideline--Updated June 2015. Endoscopy. 2015 Dec;47(12):1175-89. doi: 10.1055/s-0034-1393414. Epub 2015 Nov 12. No abstract available.
PubMed 26561915Park WY, Shin YS, Lee SK, Kim SY, Lee TK, Choi YS. Bispectral index monitoring during anesthesiologist-directed propofol and remifentanil sedation for endoscopic submucosal dissection: a prospective randomized controlled trial. Yonsei Med J. 2014 Sep;55(5):1421-9. doi: 10.3349/ymj.2014.55.5.1421.
PubMed 25048506Lera dos Santos ME, Maluf-Filho F, Chaves DM, Matuguma SE, Ide E, Luz Gde O, de Souza TF, Pessorrusso FC, de Moura EG, Sakai P. Deep sedation during gastrointestinal endoscopy: propofol-fentanyl and midazolam-fentanyl regimens. World J Gastroenterol. 2013 Jun 14;19(22):3439-46. doi: 10.3748/wjg.v19.i22.3439.
PubMed 23801836Yu YH, Han DS, Kim HS, Kim EK, Eun CS, Yoo KS, Shin WJ, Ryu S. Efficacy of bispectral index monitoring during balanced propofol sedation for colonoscopy: a prospective, randomized controlled trial. Dig Dis Sci. 2013 Dec;58(12):3576-83. doi: 10.1007/s10620-013-2833-4. Epub 2013 Aug 28.
PubMed 23982208Imagawa A, Fujiki S, Kawahara Y, Matsushita H, Ota S, Tomoda T, Morito Y, Sakakihara I, Fujimoto T, Taira A, Tsugeno H, Kawano S, Yagi S, Takenaka R. Satisfaction with bispectral index monitoring of propofol-mediated sedation during endoscopic submucosal dissection: a prospective, randomized study. Endoscopy. 2008 Nov;40(11):905-9. doi: 10.1055/s-2008-1077641.
PubMed 19023932Bower AL, Ripepi A, Dilger J, Boparai N, Brody FJ, Ponsky JL. Bispectral index monitoring of sedation during endoscopy. Gastrointest Endosc. 2000 Aug;52(2):192-6. doi: 10.1067/mge.2000.107284.
PubMed 10922090
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
- ClinicalTrials.gov ID
- NCT03461029
- Acronym / sponsor ID
- 01/16
- Conditions
- Colonoscopy
- Keywords
- Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Study start
- 30 Jan 2016 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 9 Mar 2018 (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.
The aim of the study is to establish and identify the level of sedation that is performed in the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS monitoring system, which obtains objective values in real time from the anesthesia performed. The monitoring is completed with basic parameters validated by European guidelines (heart rate, blood pressure, oxygen saturation and respiratory rate), capnography and Ramsay sedation scale, widely validated for use outside the operating room. The main work hypothesis was that in at least 10% of the patients BIS values compatible with moderate or deep sedation would be obtained (BIS <65).
Detailed description
Observational study in patients undergoing scheduled colonoscopy in endoscopy rooms of the Galdakao-Usansolo Hospital. The investigators objectified the level of sedation that was performed in these procedures using Bispectral Index Monitoring, as well as the total dose of medication required and the level of satisfaction obtained after completing the sedation. The incidence of hemodynamic and respiratory complications observed was included, as well as the treatment needed to solve them.
A total of 196 patients were needed to obtain statistically significant results. Qualitative variables are expressed in the form of freguencies and percentages and continuous variables in the form of means and stnadard deviations. Comparisions of percentages were made by the Chi square test and the difference of means in the continuous variables by the t test.Stadistical significance will be assumed when p<0.05. All estadistical analyzes were carried out using SAS V9.4 (SAS Institute, Inc., Carey, NC).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS | – | Device: BIS monitorGroup of 196 patients in whom sedation monitoring is performed using the Bispectral Index Monitoring (BIS) system. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the general population, residents in the geographical area corresponding to the Hospital Galdakao Usansolo, who attended the endoscopy rooms. Were included to undergo a scheduled colonoscopy, either for monitoring, diagnostic or screening, and to meet the cited inclusion criteria.
Key inclusion criteria (6 listed)
- Indication of scheduled colonoscopy.
- Classification of physical status ASA I, II and III.
- Intermitent or persistent mild asthma.
- Body Mass Index (BMI) < 35 kg/m2.
- Intact neurological capacity.
Key exclusion criteria (7 listed)
- ASA IV.
- BMI > 35 kg/m2.
- Allergy to any of the medications using in sedation, or its components.
- Known mental or neurological disease.
- Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sleep Apnea.
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 |
|---|---|---|
| BIS monitorThe investigators placed on the forehead of all patients the sensor BIS quatroTM, that connects with the monitor, and they registered sedation and recorded the values obtained. | Device | BIS |
Primary outcome
Level of sedation
Time frame: 1 year.
Sedation measured by Bispectral Index Monitoring.
2 secondary outcomes
Complications related to sedation.
Time frame: 1 year.
Level of satisfaction with the sedation.
Time frame: 1 year.
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 9 Mar 2018.
- Background: PubMed 26561915Dumonceau JM, Riphaus A, Schreiber F, Vilmann P, Beilenhoff U, Aparicio JR, Vargo JJ, Manolaraki M, Wientjes C, Racz I, Hassan C, Paspatis G. Non-anesthesiologist administration of propofol for gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates Guideline--Updated June 2015. Endoscopy. 2015 Dec;47(12):1175-89. doi: 10.1055/s-0034-1393414. Epub 2015 Nov 12. No abstract available.
- Background: PubMed 25048506Park WY, Shin YS, Lee SK, Kim SY, Lee TK, Choi YS. Bispectral index monitoring during anesthesiologist-directed propofol and remifentanil sedation for endoscopic submucosal dissection: a prospective randomized controlled trial. Yonsei Med J. 2014 Sep;55(5):1421-9. doi: 10.3349/ymj.2014.55.5.1421.
- Background: PubMed 23801836Lera dos Santos ME, Maluf-Filho F, Chaves DM, Matuguma SE, Ide E, Luz Gde O, de Souza TF, Pessorrusso FC, de Moura EG, Sakai P. Deep sedation during gastrointestinal endoscopy: propofol-fentanyl and midazolam-fentanyl regimens. World J Gastroenterol. 2013 Jun 14;19(22):3439-46. doi: 10.3748/wjg.v19.i22.3439.
- Background: PubMed 23982208Yu YH, Han DS, Kim HS, Kim EK, Eun CS, Yoo KS, Shin WJ, Ryu S. Efficacy of bispectral index monitoring during balanced propofol sedation for colonoscopy: a prospective, randomized controlled trial. Dig Dis Sci. 2013 Dec;58(12):3576-83. doi: 10.1007/s10620-013-2833-4. Epub 2013 Aug 28.
- Background: PubMed 19023932Imagawa A, Fujiki S, Kawahara Y, Matsushita H, Ota S, Tomoda T, Morito Y, Sakakihara I, Fujimoto T, Taira A, Tsugeno H, Kawano S, Yagi S, Takenaka R. Satisfaction with bispectral index monitoring of propofol-mediated sedation during endoscopic submucosal dissection: a prospective, randomized study. Endoscopy. 2008 Nov;40(11):905-9. doi: 10.1055/s-2008-1077641.
- Background: PubMed 10922090Bower AL, Ripepi A, Dilger J, Boparai N, Brody FJ, Ponsky JL. Bispectral index monitoring of sedation during endoscopy. Gastrointest Endosc. 2000 Aug;52(2):192-6. doi: 10.1067/mge.2000.107284.
- Individual participant dataSharing planned: Undecided. The information contained in the study will be published once the review of the data included in it is completed. Previously, researchers will decide if the information contained is relevant for publication on this platform.
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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.
Iratxe Gonzalez Mendibil, MD principal investigator
Hospital Galdakao-Usansolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Hospital Galdakao-Usansolo at 1 site in Spain.
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 6 inclusion and 7 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 9 Mar 2018. 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 Spain. 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?
Level of sedation (time frame: 1 year.). 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 NCT03461029, which also lists 6 linked publications.
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 9 Mar 2018.