SugammadexNCT05886218

Quantitative Neuromuscular Monitoring and Gastric Bypass Surgery

An observational study of Sugammadex, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a single site, prospective, non-blinded, non-randomized, before/after study. This study is designed to evaluate the impact of monitoring and reversal guidelines for neuromuscular blocking drugs on the post-operative outcomes for patients undergoing laparoscopic gastric bypass surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sugammadex
What is being tested?: Quantitative Neuromuscular Function Monitoring
Type of treatment: Medical device
How many people: 183 participants
Where: 1 siteUnited States
Study dates: 8 Jan 2024to 27 Aug 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: Patients scheduled for surgical procedures in the UC Davis Medical Center main ORs will be screened for potential enrollment.

Who may be able to join

age greater than 18 years
scheduled for an elective laparoscopic gastric bypass procedure

Who cannot join

age less than 18 years
pregnancy
prisoners
significant co-existing lung disease including asthma or chronic obstructive pulmonary disease (COPD) requiring regular medication
patients who require supplemental oxygen pre-operatively to maintain a hemoglobin saturation (SpO2>98%)

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Davis Medical Center
Sacramento, California, 95817

Other trials in United States

About this study

Official title: A Before/After Study of the Impact of Quantitative Neuromuscular Monitoring and Sugammadex Reversal Following Gastric Bypass Surgery

Read the detailed description

This is a single-center, prospective before-after study enrolling obese adults (BMI ≥30 kg/m²) undergoing elective intra-abdominal surgery. The intervention is a structured protocol incorporating quantitative neuromuscular monitoring and standardized sugammadex administration. The primary outcome is postoperative hypoxemic burden, calculated as the area under the curve for SpO₂ ≤90% per hour, measured with a wearable continuous pulse oximetry device during the first 24 h after surgery. Secondary outcomes include intraoperative rocuronium and sugammadex dosing, postanesthesia care unit (PACU) length of stay, postoperative supplemental oxygen requirement, and feasibility of continuous physiologic monitoring.

Conditions: Sugammadex
Being tested: Quantitative Neuromuscular Function Monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quantitative Neuromuscular Function MonitoringDevice
Quantitative electromyographic (EMG) monitoring

Study groups in NCT05886218
Study group	Role	What they receive
"Before"		Management as per current standard of care
"After"		Neuromuscular blockade (NMB) managed as per current American Society of Anesthesiologists (ASA) guidelines Receives: Device: Quantitative Neuromuscular Function Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Hypoxemic Burden (Area Under the Curve for SpO₂ ≤90%)
Postoperative hypoxemic burden was quantified as the area under the curve (AUC) for arterial oxygen saturation (SpO₂) at or below 90%, expressed in units of SpO₂%·min≤90 per hour of monitoring. Continuous SpO₂ was measured non-invasively using a wrist-worn wearable pulse oximetry device (Masimo W1) during the first 24 hours following surgery. The AUC was calculated for time periods during which SpO₂ was continuously ≤90%. A higher AUC value represents greater cumulative hypoxemic burden and is considered a worse outcome. Data were included only when continuous monitoring data were available for at least 50% of the total postoperative monitoring period (up to 24 hours).
Measured: 24 hours

Secondary outcomes (6)

Rate of Compliance
The rate of compliance with the structured neuromuscular blockade (NMB) monitoring and reversal protocol, as defined by the American Society of Anesthesiologists (ASA) guidelines. Compliance was defined as successful completion of all required protocol steps: (1) application of quantitative EMG neuromuscular monitoring device prior to NMB administration, (2) continuous intraoperative TOF (Train-of-Four) monitoring, and (3) administration of sugammadex for reversal at a TOF ratio <0.9. This outcome measure was only applicable to the 'After' Arm/Group, as the structured NMB protocol was not implemented in the 'Before' Arm/Group
Measured: 24 hours
Intraoperative Rocuronium
Total intraoperative rocuronium use/kg/hr (mg/kg/hr)
Measured: 24 hours
Sugammadex Dose
Total sugammadex dose (mg/kg)
Measured: 24 hours
Supplemental Oxygen Use
Post-operative supplemental oxygen use (L/hr)
Measured: 24 hours
PACU Length of Stay
Post-Anesthesia Care Unit (PACU) Length of stay (minutes)
Measured: 7 days
Compliance
Success rate for wearable device compliance (%)
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 202427 Aug 2025

First posted2 Jun 2023
Study start8 Jan 2024
Primary completion5 Jun 2025
Study completion27 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SugammadexStudies of the same condition, open and under way.
More trials run by University of California, DavisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05886218
Sponsor's protocol ID: 2004503
Status last verified: Jul 2026
First submitted: 23 May 2023
Last updated: 9 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruitingPhase 4
REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential Monitoring
Airway Management, Endotracheal Intubation
RecruitingObservational study
Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac Surgery
Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery
Recruiting
Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT
Major Depressive Disorder, Bipolar Disorder
Recruiting
Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal
Neuromuscular Blockade Reversal Agent, Perioperative Complications

All Sugammadex trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Before/After Study of the Impact of Quantitative Neuromuscular Monitoring and Sugammadex Reversal Following Gastric Bypass Surgery
ClinicalTrials.gov ID: NCT05886218
Acronym / sponsor ID: 2004503
Conditions: Sugammadex
Study type: Observational
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Study start: 8 Jan 2024 (actual)
Primary completion: 5 Jun 2025 (actual)
Study completion: 27 Aug 2025 (actual)
First posted: 2 Jun 2023 (actual)
Results: Posted 9 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
"Before"	–	–Management as per current standard of care
"After"	–	Device: Quantitative Neuromuscular Function MonitoringNeuromuscular blockade (NMB) managed as per current American Society of Anesthesiologists (ASA) guidelines

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Patients scheduled for surgical procedures in the UC Davis Medical Center main ORs will be screened for potential enrollment.

Key inclusion criteria (2 listed)

age greater than 18 years
scheduled for an elective laparoscopic gastric bypass procedure

Key exclusion criteria (5 listed)

age less than 18 years
pregnancy
prisoners
significant co-existing lung disease including asthma or chronic obstructive pulmonary disease (COPD) requiring regular medication
patients who require supplemental oxygen pre-operatively to maintain a hemoglobin saturation (SpO2>98%)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quantitative Neuromuscular Function MonitoringQuantitative electromyographic (EMG) monitoring	Device	"After"

Primary outcome

Postoperative Hypoxemic Burden (Area Under the Curve for SpO₂ ≤90%)
Time frame: 24 hours
Postoperative hypoxemic burden was quantified as the area under the curve (AUC) for arterial oxygen saturation (SpO₂) at or below 90%, expressed in units of SpO₂%·min≤90 per hour of monitoring. Continuous SpO₂ was measured non-invasively using a wrist-worn wearable pulse oximetry device (Masimo W1) during the first 24 hours following surgery. The AUC was calculated for time periods during which SpO₂ was continuously ≤90%. A higher AUC value represents greater cumulative hypoxemic burden and is considered a worse outcome. Data were included only when continuous monitoring data were available for at least 50% of the total postoperative monitoring period (up to 24 hours).

6 secondary outcomes

Rate of Compliance
Time frame: 24 hours
Intraoperative Rocuronium
Time frame: 24 hours
Sugammadex Dose
Time frame: 24 hours
Supplemental Oxygen Use
Time frame: 24 hours
PACU Length of Stay
Time frame: 7 days
Compliance
Time frame: 24 hours

Results and safety

Results posted to the registry on 9 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
"Before"	80	68
"After"	103	67

Primary outcome: Postoperative Hypoxemic Burden (Area Under the Curve for SpO₂ ≤90%)

Time frame: 24 hours. Median (Inter-Quartile Range). Unit: SpO2%∙min≤90

Measure	"Before" n = 68	"After" n = 67
Value	123 (58 to 221)	74 (27 to 145)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
"Before"	8 of 68 (11.8%)	0 of 68 (0%)	0 of 68
"After"	2 of 67 (3%)	0 of 67 (0%)	0 of 67

Limitations and caveats (from the sponsor): The watch had no storage capacity and required a continuous Bluetooth connection to an iPad which then required an uninterrupted internet connection. This communication chain was frequently broken as patients were transported throughout the hospital and there was a large percentage of data loss. The study size was adequately powered for the primary outcome measurement, but insufficient to allow any sub-group analysis among the obesity classes. Larger studies are required for validation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sugammadex

Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruitingPhase 4
REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential Monitoring
Airway Management, Endotracheal Intubation
RecruitingObservational study
Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac Surgery
Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery
Recruiting
Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT
Major Depressive Disorder, Bipolar Disorder
Recruiting
Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal
Neuromuscular Blockade Reversal Agent, Perioperative Complications

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sugammadex, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Hypoxemic Burden (Area Under the Curve for SpO₂ ≤90%) (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05886218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.