Trial Outcomes & Findings for The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications (NCT NCT02861131)

NCT ID: NCT02861131

Last Updated: 2020-03-31

Results Overview

A composite outcome which includes any of the following: postoperative pneumonia, aspiration pneumonitis, atelectasis, pneumothorax, desaturation/hypoxemia, upper airway obstruction, or acute respiratory insufficiency

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 200 participants
• Primary outcome timeframe: Length of hospitalization, an average of 1 week
• Results posted on: 2020-03-31

Participant Flow

Participant milestones

Measure	Sugammadex Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications

Baseline characteristics by cohort

Measure	Sugammadex n=100 Participants Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 Participants Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.	Total n=200 Participants Total of all reporting groups
Age, Continuous	74.8 years STANDARD_DEVIATION 4.3 • n=5 Participants	75.1 years STANDARD_DEVIATION 4.0 • n=7 Participants	74.9 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	56 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	44 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	97 Participants n=5 Participants	93 Participants n=7 Participants	190 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: Length of hospitalization, an average of 1 week

A composite outcome which includes any of the following: postoperative pneumonia, aspiration pneumonitis, atelectasis, pneumothorax, desaturation/hypoxemia, upper airway obstruction, or acute respiratory insufficiency

Outcome measures

Measure	Sugammadex n=100 Participants Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 Participants Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Number of Participants With a Postoperative Pulmonary Complication	33 Participants	40 Participants

SECONDARY outcome

Timeframe: 1 day

Residual neuromuscular blockade will be defined as a train-of-four ratio < 0.9 taken within 5 minutes of subject arrival in the PACU

Outcome measures

Measure	Sugammadex n=100 Participants Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 Participants Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Number of Participants With Residual Neuromuscular Blockade in the PACU	9 Participants	46 Participants

SECONDARY outcome

Timeframe: 1 day

Defined as duration of time required to attain pain control and stable respiratory, haemodynamic, and neurological status

Outcome measures

Measure	Sugammadex n=100 Participants Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 Participants Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
PACU Phase 1 Recovery Time	97.3 minutes Standard Deviation 54.3	110.0 minutes Standard Deviation 62

OTHER_PRE_SPECIFIED outcome

Timeframe: Length of hospitalization, an average of 1 week

Defined as the number of days between hospital admission and discharge

Outcome measures

Measure	Sugammadex n=100 Participants Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 Participants Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Hospital Length of Stay	4.0 days Standard Deviation 3.4	4.5 days Standard Deviation 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Length of hospitalization plus 30 days post-discharge

The proportion of patients that require hospital readmission for any cause within 30 days of hospital discharge

Outcome measures

Measure	Sugammadex n=100 Participants Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 Participants Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Number of Participants With Hospital Readmission Within 30 Days	5 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Length of hospitalization, an average of 1 week

pneumonia, unplanned re-intubation for any reason other than a return trip to the operating room, and ventilator times greater than 48 hours - excluding operating room time

Outcome measures

Measure	Sugammadex n=100 Participants Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 Participants Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Number of Participants Diagnosed With a National Surgical Quality Improvement Program (NSQIP) Defined Respiratory Complication	4 Participants	2 Participants

Adverse Events

Sugammadex

Serious events: 2 serious events

Other events: 50 other events

Deaths: 2 deaths

Neostigmine

Serious events: 3 serious events

Other events: 52 other events

Deaths: 1 deaths

Serious adverse events

Measure	Sugammadex n=100 participants at risk Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 participants at risk Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Musculoskeletal and connective tissue disorders Significant Residual Neuromuscular Paralysis	0.00% 0/100 • 30 days after discharge from the hospital	2.0% 2/100 • Number of events 2 • 30 days after discharge from the hospital
Cardiac disorders Myocardial Infarction	0.00% 0/100 • 30 days after discharge from the hospital	1.0% 1/100 • Number of events 1 • 30 days after discharge from the hospital
Nervous system disorders Cerebrovascular Accident	1.0% 1/100 • Number of events 1 • 30 days after discharge from the hospital	0.00% 0/100 • 30 days after discharge from the hospital
Infections and infestations Pneumonia leading to death	1.0% 1/100 • Number of events 1 • 30 days after discharge from the hospital	0.00% 0/100 • 30 days after discharge from the hospital

Other adverse events

Measure	Sugammadex n=100 participants at risk Sugammadex 2 mg/kg IV once at the end of surgery Sugammadex: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow	Neostigmine n=100 participants at risk Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery Neostigmine: At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.0% 1/100 • Number of events 1 • 30 days after discharge from the hospital	2.0% 2/100 • Number of events 2 • 30 days after discharge from the hospital
Respiratory, thoracic and mediastinal disorders Cough	4.0% 4/100 • Number of events 4 • 30 days after discharge from the hospital	5.0% 5/100 • Number of events 5 • 30 days after discharge from the hospital
Nervous system disorders Headache	7.0% 7/100 • Number of events 7 • 30 days after discharge from the hospital	7.0% 7/100 • Number of events 7 • 30 days after discharge from the hospital
Gastrointestinal disorders Nausea or Vomiting	14.0% 14/100 • Number of events 14 • 30 days after discharge from the hospital	17.0% 17/100 • Number of events 17 • 30 days after discharge from the hospital
Skin and subcutaneous tissue disorders Itching	5.0% 5/100 • Number of events 5 • 30 days after discharge from the hospital	8.0% 8/100 • Number of events 8 • 30 days after discharge from the hospital
Gastrointestinal disorders Foul, salty or metallic taste	19.0% 19/100 • Number of events 19 • 30 days after discharge from the hospital	13.0% 13/100 • Number of events 13 • 30 days after discharge from the hospital

Additional Information

Brandon Togioka

Oregon Health & Science University

Phone: 5034944572

Email: togioka@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place