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NCT Number: NCT04410211

Comparison Between Two Types of Sedation for Elective Upper Endoscopy Procedures

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.

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Key information

Conditions

Gastro Esophageal Reflux Deglutition Disorders Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophageal Motility Disorders Gastric Ulcer Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Sedation Complication Stomach Diseases Stomach Ulcer

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, WP Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sevoflurane

Drug

Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed

Post procedural recovery scoring are taken which includes:

  • Time taken from the point that the procedure ended to the first OAAS score of 5
  • Time taken from (a) to meeting discharge eligilibility

Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator

Midazolam injection

Drug

Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed

Post procedural recovery scoring are taken which includes:

  • Time taken from the point that the procedure ended to the first OAAS score of 5
  • Time taken from (a) to meeting discharge eligilibility

Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator.

Primary outcomes

  1. Psychomotor recovery time

    Time frame: 30 minutes from completion of procedure

    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.

  2. Time taken to fulfil discharge criteria

    Time frame: One day

    Patient would have to fulfil a set of discharge criteria to ensure that patient is safe for discharge.

Secondary outcomes

  1. Patient and endoscopists satisfaction

    Time frame: Post procedure on the same setting not more than one day duration

    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)

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

A Comparative Study Between Inhalational Sevoflurane Sedation With Intravenous Midazolam Sedation for Upper Endoscopy Procedure.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2020
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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