Clinical trial NCT01081002: Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
Official title: Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conscious Sedation
Keywords: Propofol
Conscious sedation
Topical pharyngeal anesthesia
Anesthetics, Local
Gastrointestinal Endoscopy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Scheduled diagnostic upper endoscopy
* Wish to be sedated
* ASA class I - III
* Signed informed consent

Exclusion Criteria:

* Emergency medical examinations
* Therapeutic Endoscopy
* ASA class IV
* Pregnancy
* Known allergy to propofol or lidocaine

Primary outcomes:
measure: Number triggered gag reflex during the intubation of the endoscope
timeFrame: Start of the exam until the successful intubation of the esophagus with the endoscope
measure: Number of attempts of intubation with the endoscope through the upper esophageal sphincter
timeFrame: Start of the exam until the successful intubation of the esophagus with the endoscope
measure: Extent of salivation during intubation
timeFrame: Start of the exam until the successful intubation of the esophagus with the endoscope
Secondary outcomes:
measure: Amount of propofol used to successfully intubate the esophagus
timeFrame: Start of the exam until the successful intubation of the esophagus with the endoscope
measure: Total amount of propofol used during the investigation
timeFrame: From the start until the end of the exam
measure: Overall assessment of the procedure by the endoscopist
timeFrame: Immediately after finishing the endoscopy
measure: Assumption of the endoscopist if lidocaine or placebo has been used
timeFrame: Immediately after finishing the endoscopy
measure: Overall assessment of the investigation by the patient
timeFrame: Immediately after recovery of consciousness of the patient
measure: Extent of amnesia in the patient
timeFrame: Immediately after recovery of consciousness of the patient
measure: Experienced problems (aspiration, bronchospasm, desaturation)
timeFrame: From the start until the end of the exam
measure: The impact of the individual endoscopists or registered nurses involved in the endoscopy
timeFrame: After finishing the entire study
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital; Division of Gastroenterology and Hepatology
state: BS
city: Zollikerberg
country: Switzerland
facility: Hospital of Zollikerberg, Internal Medicine
state: ZH
Study officials:
affiliation: Spital Zollikerberg
name: Ludwig T Heuss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Lukas Degen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.