The effectiveness of xylocaine spray in upper gastrointestinal endoscopy

The effect of 10% xylocaine spray compared to a placebo on ease of endoscopy and hemodynamic changes in patients admitted for upper gastrointestinal endoscopy under deep sedation with total intravenous anesthesia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000143921

Enrollment

129

Registered

2011-02-08

Start date

2010-12-25

Completion date

2011-12-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The use of topical pharyngeal anesthesia has long been controversial among the anesthetists and no evidence has well supported the use of the spray. The use of lidocaine spray is not without adverse effects, which include aspiration pneumonia, methemoglobinemia and anaphylaxis. Most of the patients undergo endoscopies under general anesthesia and theoretically should not require pharngeal spray to suppress pharyngeal reflexes during the procedure. The aim of the study is determine whether the use of the spray is necessary in patients under deep sedation/general anesthesia. Deep sedation is achieved by total intravenous anesthesia (TIVA) with propofol.

Interventions

Patients are randomly assigned to have 10% lidocaine spray (approximately 30mg) or normal saline in their throat on arrival, approximately 3 minutes before upper gastrointestinal endoscopy.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

20 Years to 69 Years

Healthy volunteers

Inclusion criteria

1. All participants who sign the consent and agreement form 2. All participants who are admitted for upper gastrointestinal endoscopy under general anesthesia with total intravenous anesthesia 3. All participants who are between the age of 20 and 69

Exclusion criteria

1. young age <20 years; old age >69 years 2. participants who are reported to have allergic reaction to the anesthetic agents used in the study (lidocaine) 3. pregnant women or who are breastfeeding 4. participants who are deemed to have significant higher risk if enrolled in the study (eg severe obstructive sleep apnea)

Outcome results