CompletedPhase 4

Optimal Anesthesia for Morbidly Obese Patients

Taiwan80 participantsStarted 2020-05-26

Plain-language summary

Obese patients have a higher risk of anesthesia compared to the non-obese, including difficult intubation, rapid desaturation, difficult vascular access, and delayed recovery from anesthesia. This study aims to investigate the optimal anesthesia strategy for morbidly obese patients undergoing bariatric surgery in airway management, preoxygenation, arterial cannulation, and type of volatile anesthetic with M-Entropy guidance. The investigators will conduct a two-year clinical trial using permuted block randomization to evaluate multiple outcomes in patients undergoing laparoscopic sleeve gastrectomy (LSG) at Shuang Ho Hospital, Taipei Medical University. Particularly, the investigators will explore the role of ultrasound, an easily accessible modality for anesthesiologists, in examining upper airway anatomy and guiding arterial cannulation. The investigators will also assess the effectiveness of high-flow nasal cannula as a preoxygenation tool in preventing desaturation.

Who can participate

Age range

20 Years – 65 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: * Age 20 to 65 years * BMI ≥ 30 kg/m2 * Undergoing laparoscopic sleeve gastrectomy at Shuang-Ho Hospital, Taiwan Exclusion Criteria: * Severe cardiopulmonary disease * Psychiatric disorder * History of head and neck surgery or radiation therapy * Cervical spine injury * Renal insufficiency (estimated creatinine clearance \< 60 ml/min) * SpO2 \< 90% in room air * Hemodynamic instability * Preexisting arterial catheterization during the same visit within 7 days * Patient refusal

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

Occurrence of difficult laryngoscopy

Timeframe: One day before surgery to tracheal intubation

First-attempt success rate for arterial cannulation

Timeframe: Before induction of anesthesia

PaO2 after preoxygenation

Timeframe: Before induction of anesthesia

Time to spontaneous eye opening

Timeframe: The period from discontinuation of volatile anesthetics to spontaneous eye opening, an average of 15 minutes

Trial details

NCT IDNCT04395248

SponsorTaipei Medical University Shuang Ho Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-31

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

20 Years – 65 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.

What they're measuring

Occurrence of difficult laryngoscopy

Timeframe: One day before surgery to tracheal intubation

First-attempt success rate for arterial cannulation

Timeframe: Before induction of anesthesia

PaO2 after preoxygenation

Timeframe: Before induction of anesthesia

Time to spontaneous eye opening

Timeframe: The period from discontinuation of volatile anesthetics to spontaneous eye opening, an average of 15 minutes