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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 10% | Drug | 3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number triggered gag reflex during the intubation of the endoscope | 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 | Start of the exam until the successful intubation of the esophagus with the endoscope | |
| Extent of salivation during intubation | Start of the exam until the successful intubation of the esophagus with the endoscope |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of propofol used to successfully intubate the esophagus | Start of the exam until the successful intubation of the esophagus with the endoscope | |
| Total amount of propofol used during the investigation | From the start until the end of the exam |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ludwig T Heuss, MD | Spital Zollikerberg | Principal Investigator |
| Lukas Degen, Prof | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital; Division of Gastroenterology and Hepatology | Basel | Canton of Basel-City | 4031 | Switzerland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22000794 | Derived | 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. |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C000713218 | gentian root extract |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Diluted gentian root solution | Drug | 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 |
|
|
| Overall assessment of the procedure by the endoscopist | Immediately after finishing the endoscopy |
| Assumption of the endoscopist if lidocaine or placebo has been used | Immediately after finishing the endoscopy |
| Overall assessment of the investigation by the patient | Immediately after recovery of consciousness of the patient |
| Extent of amnesia in the patient | Immediately after recovery of consciousness of the patient |
| Experienced problems (aspiration, bronchospasm, desaturation) | From the start until the end of the exam |
| The impact of the individual endoscopists or registered nurses involved in the endoscopy | After finishing the entire study |
| Hospital of Zollikerberg, Internal Medicine |
| Zollikerberg |
| Canton of Zurich |
| 8125 |
| Switzerland |
| Aniline Compounds |
| D000588 | Amines |