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Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

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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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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