Gastric Ulcer Clinical Trial
Official title:
A Comparative Study Between Inhalational Sevoflurane Sedation With Intravenous Midazolam Sedation for Upper Endoscopy Procedure.
Verified date | May 2020 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 30, 2019 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | University Malaya Medical Centre | Kuala Lumpur | WP Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychomotor recovery time | Pre procedure psychomotor tests baseline scores will be obtained and compared with post procedure scores. Time to achieve baseline recovery scores will be taken and used to compare between the two sedative agents. | 30 minutes from completion of procedure | |
Primary | Time taken to fulfil discharge criteria | Patient would have to fulfil a set of discharge criteria to ensure that patient is safe for discharge. | One day | |
Secondary | Patient and endoscopists satisfaction | Patient will answer a set of questionnaires to gauge the satisfaction of the sedation agent. Endoscopists will score their satisfaction with a scale of 1 to 10, with 1 - 3 being (dissatisfied), 4-6 (satisfied), and 7 - 10 (very satisfied) | Post procedure on the same setting not more than one day duration |
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