Draft safety review: delayed gastric emptying and procedural sedation
Consultation on the draft safety review of delayed gastric emptying and residual gastric content in patients receiving an incretin receptor agonist who present for procedural sedation. The review assesses a signal drawn largely from imaging studies and case…
§1Consultation and window
§1.1Window
- Opened
- 12 October 2025
- Closed
- 23 November 2025
- Duration
- 42 days
- Status
- Closed — the disposition is published
- Document under consultation
- Synthesis: Delayed gastric emptying, residual gastric content and procedural…
- Submissions received
- 15
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the low certainty rating appropriate for a signal supported by observational imaging evidence and case reports rather than by randomised comparison?
- Should the review state a period of withholding, or state that the evidence does not support a specific period and record what professional bodies have advised?
- Is the absence of an event in trials of conventional size treated correctly, that is as uninformative rather than as reassurance?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The review was amended before ratification. It states no withholding period of its own, records the advice issued by professional bodies with attribution and date, and carries an explicit statement that the randomised evidence base was not designed to detect this outcome.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.