WithdrawnNot Applicable

Feasibility of Using Depth-of-sedation Measuring Equipment (BIS) to Guide Awake Fibreoptic Intubation

Stopped: Difficulty in Recruitment due to lack of investigators and suitable patients

United Kingdom0Started 2010-12

Plain-language summary

The purpose of this study is to determine whether or not a device which measures depth of anaesthesia and sedation can be used to assist in the sedation of patients who must have breathing tubes positioned in their airways before general anaesthesia

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA I-III Patients scheduled for elective surgery and likely to need general anaesthesia and an awake fibreoptic intubation. * Male or female patients aged from 18 to 79 years old will be included. * Patients must be willing and able to give informed consent for participation in the study. Exclusion Criteria: * Patients under 18 * pregnant women * patients requiring emergency surgery * Patients of ASA status IV and V * Inability to communicate * Allergy to any of the drugs used, in particular remifentanil and propofol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine if bispectral index (BIS) can be used to guide conscious sedation for awake fibreoptic intubation

Timeframe: 30 minutes

Trial details

NCT IDNCT01207154

SponsorOxford University Hospitals NHS Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-10-31

View on ClinicalTrials.gov More Known Difficult Intubation trials

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.