Comparison Between Two Types of Sedation for Elective Upper Endoscopy Procedures (NCT04410211) | Clinical Trial Compass
CompletedNot Applicable
Comparison Between Two Types of Sedation for Elective Upper Endoscopy Procedures
Malaysia30 participantsStarted 2018-06-01
Plain-language summary
Sedation is defined as the act of administrating a sedative drug to produce a state of calm or sleep. Sedation is commonly given to a patient in hospital settings to provide a tolerable and pleasant experience by relieving anxiety, pain and discomfort, as well as to expedite the duration of the procedure. Moderate sedation (conscious sedation) is the preferred state of sedation, whereby self-maintenance of ventilation and hemodynamic stability is achieved.
The primary objective of this study is to determine if inhalational Sevoflurane is a more superior sedative agent in terms of faster psychomotor recovery and time taken to fulfil discharge criteria when compared with intravenous Midazolam sedation.
Secondary objective is to determine if inhalational Sevoflurane sedation has better patient's and endoscopist's satisfaction when compared with intravenous Midazolam sedation.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ASA I to II
* Patients who are not taking sedative agents prior to procedure.
* Patients who are able to give consent for the procedure.
Exclusion Criteria:
* Patients with ischaemic heart disease, respiratory diseases and cerebrovascular disease.
* Patients who are taking opioid or sedative medications 24 hours before procedure.
* Patients with previous history of adverse effects to Sevoflurane or Midazolam.
* Pregnant patients.
* Patients with airway obstructions.
* Patients with features of difficult airway such as limited neck extension, small mouth opening of less than 3 cm, mallampati score of more than 3.
* Patients who are at risk of aspiration. Impaired gag reflex, presence of neurological disorders and impaired physical mobility.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Psychomotor recovery time
Timeframe: 30 minutes from completion of procedure