Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Conscious Sedation

Treatments: Drug: Diluted gentian root solution; Drug: Lidocaine 10%

Study type: Interventional

Funder types: Other

Identifiers

NCT01081002

EKBB 101/09

Details and patient eligibility

About

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.

Enrollment: 294 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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294 participants in 2 patient groups, including a placebo group

Anesthesia (=A) with lidocaine 10%

Active Comparator group

Description:

3 min before sedation 4 puffs of terbutaline diluted lidocaine solution (Xylocaine ® 10% spray, Astra Zeneca, London, UK) will be sprayed on the pharynx

Treatment:

Drug: Lidocaine 10%

A with diluted gentian root solution

Placebo Comparator group

Description:

3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx

Treatment:

Drug: Diluted gentian root solution