| Methods |
Design: three group parallel group trial
Purpose: study the effect of sedation and topical pharyngeal anaesthesia on cardiorespiratory safety during gastroscopy |
| Participants |
Patients: patients undergoing gastroscopy
Baseline comparability: yes |
| Interventions |
Placebo: spray (NS) and injection (saline)
Untreated: no spray or sedation injection
Experimental: topical lidocaine spray or midazolam injection)
(Co‐intervention: NS) |
| Outcomes |
Heart rate
Blood pressure (diastolic and systolic)
Saturation of Oxygen |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'The patient, the endoscopist, and the endoscopy nurse were all blinded as to whether the patient received effective drug or placebo' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
Low risk |
N = 128 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
