ColonoscopyNCT03607110
Comparison of Efficacy of Anesthesia Administered by Endoscopist or Anesthesiologist on Colonoscopy
An observational study of Colonoscopy and Ketamine, run by Selda KAYAALTI at 1 site in Turkey (Türkiye).
Trial summary
In sedation applications performed by an endoscopist or anesthetist during colonoscopy, it was investigated whether there were differences in pain levels evaluated by VAS (Visuel analog scale), patient satisfaction, duration of procedure and side effects Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy, Ketamine, Fentanyl
- What is being tested?
- Ketamine and fentanyl
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Jun 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: colonoscopy patients with ASA I-II group
Who may be able to join
- Patients who accept the method and will undergo elective colonoscopy
- ASA I-II group
- Patients with the ability to perform VAS scoring
Who cannot join
- Patients who do not accept the method
- ASA III-IV-V group of patients with uncontrolled chronic disease (such as uncontrolled hypertension, uncontrolled diabetes mellitus)
- Patients with severe respiratory failure and cardiovascular disease
- Patients with liver and kidney failure
- Patients with long-term analgesic, opioid, sedative use history - Patients who are known to be hypersensitive to study medications, eggs,
- Those who are of pregnancy or pregnancy and those who are in breastfeeding period
- Those with antipsychotic or antidepressant medication usage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Develi Hatice Muammer Kocatürk Devlet Hastanesi
Develi, Kayseri
About this study
Official title: Comparison of Ketamine-propofol Sedation Protocols With Fentanyl-propofol Administered by Endoscopist or Anesthesiologist at Colonoscopy
In sedation applications performed by an endoscopist or anesthetist during colonoscopy, it was investigated whether there were differences in pain levels evaluated by VAS (Visuel analog scale), patient satisfaction, duration of procedure and side effects
Read the detailed description
Gastrointestinal endoscopes are an invasive and unpleasant procedure that is increasingly being performed worldwide (1). Colonoscopy; is one of the endoscopic procedures that can be used to diagnose and treat large intestine and cause pain and excessive discomfort in the patient (2). For this reason, intravenous (iv) sedative agents are used in endoscopy centers where endoscopy will be performed. However, side effects such as hypoxia and hypotension, which are usually dose-dependent, caused by these sedative agents, play an important role among risk factors associated with colonoscopy (3). For this reason, the use of propofol as an anesthetic is prohibited in some countries, which is a commonly used agent for sedation. However, the presence of an anesthetist during each endoscopy procedure is difficult because there are not enough anesthetists. This application is also more costly. For this reason, studies have been carried out during the gastrointestinal endoscopy when sedation is delivered by someone other than the anesthetist (4). For this purpose, several studies comparing patient-controlled sedation or sedation applied by an endoscopist to sedation performed by anesthesiologist were performed (4, 5). Investigators aimed to investigate whether there is any difference between the two groups in terms of pain levels assessed by VAS (Visuel analog scale) and patient satisfaction by comparing sedation protocols applied by endoscopist or anesthesist during colonoscopy in this study.
- Conditions
- Colonoscopy, Ketamine, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
sedation drugs
fentanylDrug
sedation drugs
patient control analgesiaDevice
patient control analgesia
| Study group | Role | What they receive |
|---|---|---|
| ketamine | ketamine used Receives: Drug: Ketamine; Device: patient control analgesia | |
| fentanyl | fentanyl used Receives: Drug: fentanyl; Device: patient control analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level - VAS SCALE
Pain level assessed by VAS
Measured: during the operation
patient satisfaction - Patient satisfaction Scale
patient satisfaction assessed by with satisfaction score of 4 points-scale (1 very good, 2 good, 3 not bad, 4 bad)
Measured: during the operation
Secondary outcomes (2)
operation time
duration of operation time will be asssessed as min.
Measured: during the operation
side effects questionnaire
Cardio pulmonary side effects (Hypotension, Bradycardia, Desaturation) and other side effects (Nausea and Vomiting, Headache)
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Mar 2018
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selda KAYAALTI
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Selda KAYAALTI, Develi Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607110
- Sponsor's protocol ID
- 2018/94
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Ferreira AO, Cravo M. Sedation in gastrointestinal endoscopy: Where are we at in 2014? World J Gastrointest Endosc. 2015 Feb 16;7(2):102-9. doi: 10.4253/wjge.v7.i2.102.
PubMed 25685266Dal H., S. İzdeş, E. Kesimci, et al. Kolonoskopide sedasyon için propofolün aralıklı bolus veya hedef kontrollü infüzyon yöntemiyle uygulanmasının karşılaştırılması, Türk Anest Rean Der Dergisi, 2011; 39(3): 134-142
Lee DW, Chan AC, Sze TS, Ko CW, Poon CM, Chan KC, Sin KS, Chung SC. Patient-controlled sedation versus intravenous sedation for colonoscopy in elderly patients: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Nov;56(5):629-32. doi: 10.1067/mge.2002.128919.
PubMed 12397267Poincloux L, Laquiere A, Bazin JE, Monzy F, Artigues F, Bonny C, Abergel A, Dapoigny M, Bommelaer G. A randomized controlled trial of endoscopist vs. anaesthetist-administered sedation for colonoscopy. Dig Liver Dis. 2011 Jul;43(7):553-8. doi: 10.1016/j.dld.2011.02.007. Epub 2011 Mar 29.
PubMed 21450542Crepeau T, Poincloux L, Bonny C, Lighetto S, Jaffeux P, Artigue F, Walleckx P, Bazin JE, Dapoigny M, Bommelaer G. Significance of patient-controlled sedation during colonoscopy. Results from a prospective randomized controlled study. Gastroenterol Clin Biol. 2005 Nov;29(11):1090-6. doi: 10.1016/s0399-8320(05)82172-4.
PubMed 16505753
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ketamine-propofol Sedation Protocols With Fentanyl-propofol Administered by Endoscopist or Anesthesiologist at Colonoscopy
- ClinicalTrials.gov ID
- NCT03607110
- Acronym / sponsor ID
- 2018/94
- Conditions
- Colonoscopy, Ketamine, Fentanyl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Selda KAYAALTIOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 31 Jul 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.
In sedation applications performed by an endoscopist or anesthetist during colonoscopy, it was investigated whether there were differences in pain levels evaluated by VAS (Visuel analog scale), patient satisfaction, duration of procedure and side effects
Detailed description
Gastrointestinal endoscopes are an invasive and unpleasant procedure that is increasingly being performed worldwide (1). Colonoscopy; is one of the endoscopic procedures that can be used to diagnose and treat large intestine and cause pain and excessive discomfort in the patient (2). For this reason, intravenous (iv) sedative agents are used in endoscopy centers where endoscopy will be performed. However, side effects such as hypoxia and hypotension, which are usually dose-dependent, caused by these sedative agents, play an important role among risk factors associated with colonoscopy (3). For this reason, the use of propofol as an anesthetic is prohibited in some countries, which is a commonly used agent for sedation. However, the presence of an anesthetist during each endoscopy procedure is difficult because there are not enough anesthetists. This application is also more costly. For this reason, studies have been carried out during the gastrointestinal endoscopy when sedation is delivered by someone other than the anesthetist (4). For this purpose, several studies comparing patient-controlled sedation or sedation applied by an endoscopist to sedation performed by anesthesiologist were performed (4, 5). Investigators aimed to investigate whether there is any difference between the two groups in terms of pain levels assessed by VAS (Visuel analog scale) and patient satisfaction by comparing sedation protocols applied by endoscopist or anesthesist during colonoscopy in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine | – | Drug: Ketamine, Device: patient control analgesiaketamine used |
| fentanyl | – | Drug: fentanyl, Device: patient control analgesiafentanyl used |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colonoscopy patients with ASA I-II group
Key inclusion criteria (3 listed)
- Patients who accept the method and will undergo elective colonoscopy
- ASA I-II group
- Patients with the ability to perform VAS scoring
Key exclusion criteria (7 listed)
- Patients who do not accept the method
- ASA III-IV-V group of patients with uncontrolled chronic disease (such as uncontrolled hypertension, uncontrolled diabetes mellitus)
- Patients with severe respiratory failure and cardiovascular disease
- Patients with liver and kidney failure
- Patients with long-term analgesic, opioid, sedative use history - Patients who are known to be hypersensitive to study medications, eggs,
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 |
|---|---|---|
| Ketaminesedation drugs | Drug | ketamine |
| fentanylsedation drugs | Drug | fentanyl |
| patient control analgesiapatient control analgesia | Device | fentanyl, ketamine |
Primary outcome
pain level - VAS SCALE
Time frame: during the operation
Pain level assessed by VAS
patient satisfaction - Patient satisfaction Scale
Time frame: during the operation
patient satisfaction assessed by with satisfaction score of 4 points-scale (1 very good, 2 good, 3 not bad, 4 bad)
2 secondary outcomes
operation time
Time frame: during the operation
side effects questionnaire
Time frame: during the operation
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 Jul 2018.
- Background: PubMed 25685266Ferreira AO, Cravo M. Sedation in gastrointestinal endoscopy: Where are we at in 2014? World J Gastrointest Endosc. 2015 Feb 16;7(2):102-9. doi: 10.4253/wjge.v7.i2.102.
- BackgroundDal H., S. İzdeş, E. Kesimci, et al. Kolonoskopide sedasyon için propofolün aralıklı bolus veya hedef kontrollü infüzyon yöntemiyle uygulanmasının karşılaştırılması, Türk Anest Rean Der Dergisi, 2011; 39(3): 134-142
- Background: PubMed 12397267Lee DW, Chan AC, Sze TS, Ko CW, Poon CM, Chan KC, Sin KS, Chung SC. Patient-controlled sedation versus intravenous sedation for colonoscopy in elderly patients: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Nov;56(5):629-32. doi: 10.1067/mge.2002.128919.
- Background: PubMed 21450542Poincloux L, Laquiere A, Bazin JE, Monzy F, Artigues F, Bonny C, Abergel A, Dapoigny M, Bommelaer G. A randomized controlled trial of endoscopist vs. anaesthetist-administered sedation for colonoscopy. Dig Liver Dis. 2011 Jul;43(7):553-8. doi: 10.1016/j.dld.2011.02.007. Epub 2011 Mar 29.
- Background: PubMed 16505753Crepeau T, Poincloux L, Bonny C, Lighetto S, Jaffeux P, Artigue F, Walleckx P, Bazin JE, Dapoigny M, Bommelaer G. Significance of patient-controlled sedation during colonoscopy. Results from a prospective randomized controlled study. Gastroenterol Clin Biol. 2005 Nov;29(11):1090-6. doi: 10.1016/s0399-8320(05)82172-4.
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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.
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?
An observational study of Colonoscopy and Ketamine, run by Selda KAYAALTI at 1 site in Turkey (Türkiye).
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 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 31 Jul 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 Turkey (Türkiye). 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?
pain level - VAS SCALE (time frame: during the operation). The study lists 2 primary outcomes in all. 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 NCT03607110, which also lists 5 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 31 Jul 2018.