Sedation Complication Clinical Trial
Official title:
A Comparative Study Between Inhalational Sevoflurane Sedation With Intravenous Midazolam Sedation for Upper Endoscopy Procedure.
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.
A randomized controlled trial study was done on patients undergoing elective upper gastrointestinal endoscopy in a single tertiary Centre in Malaysia. The study was approved by University Malaya Medical Centre medical research ethics committee. All patients gave written and informed consent. Patients were fasted, and three psychometric tests were performed as a baseline before sedation. Patients were randomly allocated to either receive IV Midazolam (Group M) or inhalational Sevoflurane (Group S) via nasal mask. Standard monitoring was applied. Patients in Sevoflurane group received the inhalational agent via a nasal mask with stepwise increment until and Observed Assessment of Alertness/Sedation Scale of 3 or maximum 1.0 minimum alveolar concentration was achieved. Patients in Midazolam group were given a stat dose of IV Midazolam 2.5mg. Both groups received 30mcg of IV Fentanyl and lignocaine 1% gargle prior to the procedure. The unblinded observer monitored the level of sedation and recorded the patient's vital signs. A second blinded observer performed the psychometric tests before and at the end of the procedure. He also recorded the time to fulfil discharge criteria as well as the satisfaction scores from the patient and endoscopist. ;
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