Conscious SedationPhase 4NCT01081002
Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
A Phase 4 study testing Lidocaine 10% and Diluted gentian root solution in people with Conscious Sedation, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol sedation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Lidocaine 10% and Diluted gentian root solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Aug 2009to May 2010
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled diagnostic upper endoscopy
- Wish to be sedated
- ASA class I - III
- Signed informed consent
Who cannot join
- Emergency medical examinations
- Therapeutic Endoscopy
- ASA class IV
- Pregnancy
- Known allergy to propofol or lidocaine
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital; Division of Gastroenterology and Hepatology
Basel, Canton of Basel-City, 4031
Hospital of Zollikerberg, Internal Medicine
Zollikerberg, Canton of Zurich, 8125
About this study
Official title: Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol.
Patients will be randomized to receive a topical pharyngeal spray containing either an anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be conducted in its standard manner.
- Conditions
- Conscious Sedation
- Being tested
- Lidocaine 10%, Diluted gentian root solution
- Keywords
- Propofol, Conscious sedation, Topical pharyngeal anesthesia, Anesthetics, Local, Gastrointestinal Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 10%Drug
Also called Xylocaine 10% spray
3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia
Diluted gentian root solutionDrug
Also called Gentian root extract, CAS no. 72968-42-4
As a basis, an infusion of water (45%), ethanol (35%) and gentian root cut will be used. The gentian root infusion is approved as a natural flavor in the food industry.3 min before the endoscopy under propofol sedation 4 puffs of this gentian root infusion will be sprayed on the pharynx as a pharyngeal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia (=A) with lidocaine 10% | Active comparator | 3 min before sedation 4 puffs of terbutaline diluted lidocaine solution (Xylocaine ® 10% spray, Astra Zeneca, London, UK) will be sprayed on the pharynx Receives: Drug: Lidocaine 10% |
| A with diluted gentian root solution | Placebo comparator | 3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx Receives: Drug: Diluted gentian root solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number triggered gag reflex during the intubation of the endoscope
Measured: Start of the exam until the successful intubation of the esophagus with the endoscope
Number of attempts of intubation with the endoscope through the upper esophageal sphincter
Measured: Start of the exam until the successful intubation of the esophagus with the endoscope
Extent of salivation during intubation
Measured: Start of the exam until the successful intubation of the esophagus with the endoscope
Secondary outcomes (8)
Amount of propofol used to successfully intubate the esophagus
Measured: Start of the exam until the successful intubation of the esophagus with the endoscope
Total amount of propofol used during the investigation
Measured: From the start until the end of the exam
Overall assessment of the procedure by the endoscopist
Measured: Immediately after finishing the endoscopy
Assumption of the endoscopist if lidocaine or placebo has been used
Measured: Immediately after finishing the endoscopy
Overall assessment of the investigation by the patient
Measured: Immediately after recovery of consciousness of the patient
Extent of amnesia in the patient
Measured: Immediately after recovery of consciousness of the patient
Experienced problems (aspiration, bronchospasm, desaturation)
Measured: From the start until the end of the exam
The impact of the individual endoscopists or registered nurses involved in the endoscopy
Measured: After finishing the entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conscious SedationStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Degen, University Hospital, Basel, Switzerland
- Investigators
- Ludwig T Heuss, MD, Principal investigator, Spital ZollikerbergLukas Degen, Prof, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081002
- Sponsor's protocol ID
- EKBB 101/09
- Status last verified
- Mar 2010
- First submitted
- 2 Mar 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.
PubMed 22000794
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
- ClinicalTrials.gov ID
- NCT01081002
- Acronym / sponsor ID
- EKBB 101/09
- Conditions
- Conscious Sedation
- Keywords
- Propofol, Conscious sedation, Topical pharyngeal anesthesia, Anesthetics, Local, Gastrointestinal Endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Mar 2010 (estimated)
- 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.
It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol.
Patients will be randomized to receive a topical pharyngeal spray containing either an anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be conducted in its standard manner.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthesia (=A) with lidocaine 10% | Active comparator | Drug: Lidocaine 10%3 min before sedation 4 puffs of terbutaline diluted lidocaine solution (Xylocaine ® 10% spray, Astra Zeneca, London, UK) will be sprayed on the pharynx |
| A with diluted gentian root solution | Placebo comparator | Drug: Diluted gentian root solution3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled diagnostic upper endoscopy
- Wish to be sedated
- ASA class I - III
- Signed informed consent
Key exclusion criteria (5 listed)
- Emergency medical examinations
- Therapeutic Endoscopy
- ASA class IV
- Pregnancy
- Known allergy to propofol or lidocaine
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 |
|---|---|---|
| Lidocaine 10%Also: Xylocaine 10% spray3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia | Drug | Anesthesia (=A) with lidocaine 10% |
| Diluted gentian root solutionAlso: Gentian root extract, CAS no. 72968-42-4As a basis, an infusion of water (45%), ethanol (35%) and gentian root cut will be used. The gentian root infusion is approved as a natural flavor in the food industry.3 min before the endoscopy under propofol sedation 4 puffs of this gentian root infusion will be sprayed on the pharynx as a pharyngeal anesthesia | Drug | A with diluted gentian root solution |
Primary outcome
Number triggered gag reflex during the intubation of the endoscope
Time frame: Start of the exam until the successful intubation of the esophagus with the endoscope
Number of attempts of intubation with the endoscope through the upper esophageal sphincter
Time frame: Start of the exam until the successful intubation of the esophagus with the endoscope
Extent of salivation during intubation
Time frame: Start of the exam until the successful intubation of the esophagus with the endoscope
8 secondary outcomes
Amount of propofol used to successfully intubate the esophagus
Time frame: Start of the exam until the successful intubation of the esophagus with the endoscope
Total amount of propofol used during the investigation
Time frame: From the start until the end of the exam
Overall assessment of the procedure by the endoscopist
Time frame: Immediately after finishing the endoscopy
Assumption of the endoscopist if lidocaine or placebo has been used
Time frame: Immediately after finishing the endoscopy
Overall assessment of the investigation by the patient
Time frame: Immediately after recovery of consciousness of the patient
Extent of amnesia in the patient
Time frame: Immediately after recovery of consciousness of the patient
Experienced problems (aspiration, bronchospasm, desaturation)
Time frame: From the start until the end of the exam
The impact of the individual endoscopists or registered nurses involved in the endoscopy
Time frame: After finishing the entire study
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 3 Dec 2014.
- Derived from this study: PubMed 22000794Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.
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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.
Ludwig T Heuss, MD principal investigator
Spital Zollikerberg
Lukas Degen, Prof principal investigator
University Hospital, Basel, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine 10% and Diluted gentian root solution in people with Conscious Sedation, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 4 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number triggered gag reflex during the intubation of the endoscope (time frame: Start of the exam until the successful intubation of the esophagus with the endoscope). The study lists 3 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 NCT01081002, 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 3 Dec 2014.