Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

Conscious Sedation Clinical Trial

Official title:

Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081002
• Other study ID #: EKBB 101/09
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2010
• Last updated: December 2, 2014
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: March 2010
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Conscious Sedation

Intervention

Drug:
• Lidocaine 10%
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 solution
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

Locations

Country	Name	City	State
Switzerland	University Hospital; Division of Gastroenterology and Hepatology	Basel	BS
Switzerland	Hospital of Zollikerberg, Internal Medicine	Zollikerberg	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number triggered gag reflex during the intubation of the endoscope		Start of the exam until the successful intubation of the esophagus with the endoscope	No
Primary	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	No
Primary	Extent of salivation during intubation		Start of the exam until the successful intubation of the esophagus with the endoscope	No
Secondary	Amount of propofol used to successfully intubate the esophagus		Start of the exam until the successful intubation of the esophagus with the endoscope	No
Secondary	Total amount of propofol used during the investigation		From the start until the end of the exam	No
Secondary	Overall assessment of the procedure by the endoscopist		Immediately after finishing the endoscopy	No
Secondary	Assumption of the endoscopist if lidocaine or placebo has been used		Immediately after finishing the endoscopy	No
Secondary	Overall assessment of the investigation by the patient		Immediately after recovery of consciousness of the patient	No
Secondary	Extent of amnesia in the patient		Immediately after recovery of consciousness of the patient	No
Secondary	Experienced problems (aspiration, bronchospasm, desaturation)		From the start until the end of the exam	Yes
Secondary	The impact of the individual endoscopists or registered nurses involved in the endoscopy		After finishing the entire study	No