Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

Phase 4

Completed

• Conditions: General Surgery
• Interventions: Drug: Placebo; Drug: Sugammadex

• Registration Number: NCT02728726
• Lead Sponsor: Mayo Clinic

Brief Summary

The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-05
• Study Start: 2016-06
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Disposition First Submitted: 2020-11-30
• Disposition First Submitted QC: 2020-11-30
• Disposition First Posted: 2020-12-01
• Results First Submitted: 2022-05-25
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-21
• Last Update Submitted: 2022-06-21
• Results First Posted: 2022-07-14
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Patients undergoing surgery with general anesthesia
• Patients weighing > or = 80 pounds
• Patients not intubated prior to surgery
• Patients who are able to give informed consent

Exclusion Criteria

• Patients unable to give informed consent.
• Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
• Patients who are anticipated to remain intubated in recovery period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will have Placebo administered after routine reversal of anesthesia is performed and patient is extubated.
Sugammadex	Sugammadex	Subjects will have Sugammadex administered after routine reversal of anesthesia is performed and patient is extubated.

Primary Outcome Measures

Name	Time	Method
Decreased Minute Ventilation (MV)	15---30 minutes after Post-anesthesia care unit (PACU) arrival	The number of subjects who have a MV as defined as \[MV \<80% MV predicted (MVPRED) based on Body Surface Area\]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Decreased Average Minute Ventilation (MV)	15---30 minutes after Post-anesthesia care unit (PACU) arrival	The number of subjects who have an average MV \<80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.

Secondary Outcome Measures

Name	Time	Method
Train of Four (TOF) Ratio	upon PACU discharge, approximately 8 hours	The number of subjects to have a normal TOF ratio (\>0.90) indicative of full neuromuscular recovery in the Post-anesthesia care unit (PACU)

Trial Locations

Locations (2)

The University of Texas, UTHealth; 🇺🇸 Houston, Texas, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States