WithdrawnNot Applicable

Multi-Strategy Intervention for Anesthesia Care of Obese Patients A Factorial Randomized Controlled Trial

Stopped: COVID outbreak in the community

Taiwan0Started 2022-05

Plain-language summary

The main objective of this study is to investigate the optimal anesthesia for obese patients undergoing bariatric surgery in the strategies of positive pulmonary ventilation, tracheal intubation technique, hemodynamic monitoring, and postoperative nausea and vomiting (PONV) prophylaxis, as the followed: 1. To evaluate the effectiveness and adverse effect of intravenous dexamethasone for PONV prophylaxis 2. To determine the safe inspiratory pressure to prevent the occurrence of gastric insufflation during facemask ventilation using point-of-care ultrasonography of antrum 3. To compare the effectiveness and safety between video intubating stylet and video laryngoscope in the placement of tracheal tubes 4. To apply minimally invasive CO monitors in guiding goal-directed hemodynamic therapy and assess its impact on major complications and postoperative recovery

Who can participate

Age range

20 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 years
. Body mass index ≥ 30 kg·m-2
. Undergoing laparoscopic sleeve gastrectomy at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan

Exclusion criteria

. Pregnant or lactating women
. Severe cardiopulmonary distress, including left ventricular ejection fraction \< 40%, double or triple vessel disease, New York Heart Association functional classification ≥ 3, peripheral oxygen saturation by pulse oximetry (SpO2) \< 90% in room air, and moderate to severe pulmonary hypertension.
. Previous esophageal, gastric, or duodenal surgery.

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

Substudy 1: Number of participants developing postoperative nausea and vomiting

Timeframe: The first 24 postoperative hour

Substudy 2: The threshold inspiratory pressure for gastric insufflation

Timeframe: Within 2 min after induction of anesthesia

Substudy 3: The best glottis visualization, graded according to Cormack and Lehane's classification

Timeframe: From the induction of anesthesia to the 24th postoperative hours

Substudy 4: Number of participants developing postoperative major complications

Timeframe: Within 30 days after surgery

Trial details

NCT IDNCT05016076

SponsorYingHsuanTai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08

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