Clinical trial NCT04410211: Comparison Between Two Types of Sedation for Elective Upper Endoscopy Procedures
Official title: A Comparative Study Between Inhalational Sevoflurane Sedation With Intravenous Midazolam Sedation for Upper Endoscopy Procedure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro Esophageal Reflux
Gastric Ulcer
Sedation Complication
Keywords: Sevoflurane
Midazolam
upper endoscopy
recovery
discharge time
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to either the Sevoflurane sedation arm or the Midazolam sedation arm based on a randomizer application and the selections are placed in a non-transparent envelope. Once a patient fulfills the eligibility to be recruited in the study, one envelope will be taken to see which arm will the patient be recruited into. Neither the patient nor the investigator will know.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Psychomotor recovery time
timeFrame: 30 minutes from completion of procedure
measure: Time taken to fulfil discharge criteria
timeFrame: One day
Secondary outcomes:
measure: Patient and endoscopists satisfaction
timeFrame: Post procedure on the same setting not more than one day duration
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: WP Kuala Lumpur
Study officials:
affiliation: University of Malaya
name: PEK LI GAN, MBBS
role: PRINCIPAL_INVESTIGATOR
References: