Comparison Between Two Types of Sedation for Elective Upper Endoscopy Procedures

NCT04410211 | Completed

• 1 other identifier: 2018321-6154
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro Esophageal Reflux; Gastric Ulcer; Sedation Complication

Keywords

Sevoflurane; Midazolam; upper endoscopy; recovery; discharge time

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Patient and endoscopists satisfaction

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

Study Arms (2)

Group S (inhalational Sevoflurane sedation)

ACTIVE COMPARATOR

The inhalational anaesthetic agent and oxygen will be delivered via an anaesthetic circuit with a vaporizer (Sevotec 3, Ohmeda, Streeton UK) with a nasal mask. Patients who are allocated for Sevoflurane will be given initial oxygen flow of 8L/min and then Sevoflurane was introduced at a concentration of 0.2% and was increased stepwise by 02% for every 30s up to a maximum of 1.0 minimum alveolar concentration (MAC; 2.05% end tidal). Patient's deepest sedation was recorded and adjusted to achieve optimal Observer's Assessment of Alertness/ Sedation Scale (OAAS) score of 3. Inadequate or over sedation was treated by reducing or increasing the Sevoflurane concentration dial by 0.2 - 0.6% until the desired effect is reached. Full vital signs monitoring are done for every participant

Drug: Sevoflurane

Group M (Intravenous Midazolam sedation)

ACTIVE COMPARATOR

Patients who are allocated for Midazolam will be given the similar nasal mask delivering 8L/min oxygen. However, Sevoflurane will not be introduced to these patients. Midazolam is titrated slowly to achieve OAAS score of 3 but no more than 2.5mg is to be given within 2 minutes period to patients selected to be in Midazolam group. Inadequate sedation is treated by giving slow titration of the medication based on the unblinded observer's judgement. Over sedation is treated by withholding the midazolam and continuing oxygen supplementation until the patient returned to the desired sedation level. No other sedative agents are allowed to be given to the patient or else patient will be excluded from this study.

Drug: Midazolam injection

Interventions

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: 1. Time taken from the point that the procedure ended to the first OAAS score of 5 2. 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

Group S (inhalational Sevoflurane sedation)

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: 1. Time taken from the point that the procedure ended to the first OAAS score of 5 2. 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.

Group M (Intravenous Midazolam sedation)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I to II
• Patients who are not taking sedative agents prior to procedure.
• Patients who are able to give consent for the procedure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, WP Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Stomach Ulcer

Interventions

Sevoflurane; Midazolam

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• PEK LI GAN, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. Two investigators will be selected to participate in this study, whereby one of the investigators who will be providing the care will not be masked. The other investigator who assess the pre and post procedure outcome will be masked from knowing which method is used.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee in Anaesthesiology and Critical Care

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 1, 2020
• Study Start: June 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months after publication

Locations

MY (1)