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New treatment option for Neuromuscular Blockade
Official title Comparison of Two Quantitative EMG Monitors for Deep Neuromuscular Block in Laparoscopic/Robotic and VATS Surgery
ClinicalTrials.gov ID: NCT07706504
What this study is testing
- What it's testing
- The main objective of the study is to compare the frequency of intraoperative spontaneous diaphragmatic movements and breath-initiation efforts in participants undergoing robotic and/or thoracic surgery under deep neuromuscular blockade (NMB), using either the TetraGraph or TwitchView applied to the dominant hand. These events will serve as objective indicators to evaluate each device's ability to monitor and maintain adequate deep NMB.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Adult male or female patients aged ≥ 18 years old.
- Patients undergo elective abdominal laparoscopic/robotic or thoracic video-assisted (VAT) surgeries requiring general anesthesia for greater than 3...
- Able to provide a signed, written informed consent.
- Able to speak, read, and write in English.
- ASA physical status I-III.
You likely can't join if
- Patients who require emergency surgery or an emergent intervention.
- Any documented cognitive or psychological disorders that, in the investigator's opinion, can interfere with the patient's pain perception.
- Vulnerable populations: pregnant females, prisoners, breastfeeding.
- Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study (patients with...
- Allergy or contraindications to any of the anesthetics, NMB agents, or sugammadex.
- Patients with anatomical abnormalities of the hands or arms that prevent proper placement of the sensors for nerve stimulation.
See the full eligibility criteria
- Adult male or female patients aged ≥ 18 years old.
- Patients undergo elective abdominal laparoscopic/robotic or thoracic video-assisted (VAT) surgeries requiring general anesthesia for greater than 3 hours at The Ohio State University Wexner Medical Center.
- Able to provide a signed, written informed consent.
- Able to speak, read, and write in English.
- ASA physical status I-III.
- Patients who require emergency surgery or an emergent intervention.
- Any documented cognitive or psychological disorders that, in the investigator's opinion, can interfere with the patient's pain perception.
- Vulnerable populations: pregnant females, prisoners, breastfeeding.
- Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study (patients with pre-existing neuromuscular diseases.
- Allergy or contraindications to any of the anesthetics, NMB agents, or sugammadex.
- Patients with anatomical abnormalities of the hands or arms that prevent proper placement of the sensors for nerve stimulation.
- Limited access to the monitoring area due to surgical positioning.
- Patients with peripheral vascular disease, since it may affect measurement accuracy.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.