CompletedPhase 4

CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity

Belgium60 participantsStarted 2013-04

Plain-language summary

The purpose of this study is to investigate if a deep neuromuscular block with a continuous infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with reversal of neuromuscular blockade with sugammadex results in improved surgical conditions for the surgeon and/or improved post-operative respiratory function for the patients as compared to a standard technique with an intubation dose of rocuronium and top-ups as needed to maintain a neuromuscular blockade with a train of four (TOF) count of 1-2 and reversal of neuromuscular blockade with neostigmine/glycopyrrolate. Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium and reversal with sugammadex or neostigmine/glycopyrrolate on cerebral tissue oxygenation.

Who can participate

Age range

18 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

. Able to give written informed consent
. American Society of Anaesthesiologists class I, II or III
. Obese or morbid obese as defined by BMI \> 30 and \>40 kg/m2 respectively

Exclusion criteria

. Neuromuscular disorders
. Allergies to, or contraindication for muscle relaxants, neuromuscular reversing agents, anaesthetics, narcotics
. Malignant hyperthermia
. Pregnancy or lactation

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

Subjective Evaluation of the View on the Operating Field by the Surgeon

Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Number of Intra-abdominal Pressure Rises > 18cmH2O

Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Duration of Surgery

Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Trial details

NCT IDNCT01748643

SponsorZiekenhuis Oost-Limburg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

Results submitted2017-03-13

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

18 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

. Able to give written informed consent
. American Society of Anaesthesiologists class I, II or III
. Obese or morbid obese as defined by BMI \> 30 and \>40 kg/m2 respectively

Exclusion criteria

. Neuromuscular disorders
. Allergies to, or contraindication for muscle relaxants, neuromuscular reversing agents, anaesthetics, narcotics
. Malignant hyperthermia
. Pregnancy or lactation

What they're measuring

Subjective Evaluation of the View on the Operating Field by the Surgeon

Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Number of Intra-abdominal Pressure Rises > 18cmH2O

Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Duration of Surgery

Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h