Trial Outcomes & Findings for Quality of Recovery After Reversal With Neostigmine or Sugammadex. (NCT NCT02909439)

NCT ID: NCT02909439

Last Updated: 2020-05-22

Results Overview

Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 80 participants
• Primary outcome timeframe: 30 Minutes
• Results posted on: 2020-05-22

Participant Flow

18 patients were excluded after enrollment. The reasons were (1) no longer met inclusion criteria (n =10), declined to participate (n=3), change in surgical date & logistical issues (n=5)

Participant milestones

Measure	Neostigmine Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Overall Study STARTED	31	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quality of Recovery After Reversal With Neostigmine or Sugammadex.

Baseline characteristics by cohort

Measure	Neostigmine n=31 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=31 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.	Total n=62 Participants Total of all reporting groups
Age, Continuous	53.16 years STANDARD_DEVIATION 13.2 • n=5 Participants	54.4 years STANDARD_DEVIATION 13.5 • n=7 Participants	53.8 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	28 Participants n=7 Participants	56 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Incentive Spirometry Volume	2500 mL n=5 Participants	2650 mL n=7 Participants	2500 mL n=5 Participants
Hand Grip Strength	77.11 psi STANDARD_DEVIATION 27.8 • n=5 Participants	74.4 psi STANDARD_DEVIATION 27.6 • n=7 Participants	75.8 psi STANDARD_DEVIATION 27.5 • n=5 Participants
Preoperative ability to sit up	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Minutes

Population: The discrepancy between the number of participants analyzed and participate flow module is because patients were unable to perform this measure at this time point either due to significant sedation or significant pain

Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

Outcome measures

Measure	Neostigmine n=21 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=18 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes	-700 mL Interval -1650.0 to -250.0	-862 mL Interval -1800.0 to -500.0

PRIMARY outcome

Timeframe: 60 Minutes after reversal

Population: The discrepancy between the number of participants analyzed and participate flow module is because patients were unable to perform this measure at this time point either due to significant sedation or significant pain

Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

Outcome measures

Measure	Neostigmine n=25 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=29 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes	-500 mL Interval -1300.0 to -250.0	-1150 mL Interval -1850.0 to -362.5

PRIMARY outcome

Timeframe: 120 minutes after reversal

Population: The discrepancy between the number of participants analyzed and participate flow module is because patients were unable to perform this measure at this time point either due to significant sedation or significant pain

Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

Outcome measures

Measure	Neostigmine n=27 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=27 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes	-400 mL Interval -1560.0 to -200.0	-850 mL Interval -1500.0 to -100.0

SECONDARY outcome

Timeframe: 30 minutes

Population: The discrepancy between the number of participants analyzed and participate flow module is because patients were unable to perform this measure at this time point either due to significant sedation or significant pain

Grip strength will be measured with a hand dynamometer

Outcome measures

Measure	Neostigmine n=26 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=23 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Grip Strength, Change From Baseline and Recovery Profile 30 Min	24.15 PSI Standard Deviation 20.54	21.38 PSI Standard Deviation 20.0

SECONDARY outcome

Timeframe: 60 minutes after reversal

Population: The discrepancy between the number of participants analyzed and participate flow module is because patients were unable to perform this measure at this time point either due to significant sedation or significant pain

Grip strength will be measured with a hand dynamometer

Outcome measures

Measure	Neostigmine n=28 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=29 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Grip Strength, Change From Baseline and Recovery Profile 60 Min	12.68 psi Standard Deviation 22.12	17.69 psi Standard Deviation 15.76

SECONDARY outcome

Timeframe: 120 minutes after surgery

Population: The discrepancy between the number of participants analyzed and participate flow module is because patients were unable to perform this measure at this time point either due to significant sedation or significant pain

Grip strength will be measured with a hand dynamometer

Outcome measures

Measure	Neostigmine n=28 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=29 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Grip Strength, Change From Baseline and Recovery Profile 120 Min	7.84 psi Standard Deviation 21.32	11.85 psi Standard Deviation 14.53

SECONDARY outcome

Timeframe: Immediately after surgery, up to 30 minutes

Measured time between surgery end and time of extubation (removal of breathing tube)

Outcome measures

Measure	Neostigmine n=31 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=31 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Time to Extubation	8 minutes Interval 5.0 to 16.0	7 minutes Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.

Population: The discrepancy between the number of participants analyzed and participate flow module is because we were unable to obtain TOFR data for these patients.

Train of four ratio (TOFR) is the ration of the twitch height of the 4th twitch compared to the 1st twitch during train of four neuromuscular stimulation. This measurement was performed using a TOF Watch, which in an accelemyographer. Electric current is applied to the ulnar nevre and the twitches are measured in the thumb. Adequate reversal of neuromuscular blockade is defined as a TOFR >90%.

Outcome measures

Measure	Neostigmine n=29 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=28 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Train of Four Ratio > 90% During PACU Admission	25 Participants	25 Participants

SECONDARY outcome

Timeframe: Postoperative day number one

Population: The discrepancy between the number of participants analyzed and participate flow module is because patients were unable to reach these patients on postoperative day number one.

15 question survey to assess patient's overall quality of recovery after anesthesia/surgery.

Quality of Recovery 15 Survey. Minimum: 0 Maximum: 150 Higher Scores mean a better outcome and better quality of recovery.

Part A: How have you been feeling in the last 24 hours? 0 = none of the time (poor), 10 = all of the time (excellent). Examples: able to breath easily, able to enjoy food, feeling rested. etc.

Part B: Have you had any of the following in the last 24 hours? 10 to 0, where 10 = none of the time (Excellent) and 0 = all of the time (poor). Examples: moderate pain, nausea or vomiting, feeling worried or anxious, etc.

Outcome measures

Measure	Neostigmine n=15 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=15 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Quality of Recovery 15 Survey	117 scores on a scale Interval 99.0 to 128.0	105 scores on a scale Interval 94.0 to 124.0

SECONDARY outcome

Timeframe: Within 4 hours from the end of surgery

Measured time between PACU admission and meeting PACU discharge readiness. PACU discharge was defined as when the patient had an Aldrete score of 9 or higher as determined by the PACU nurse. The Aldrete score is a measure of post anesthesia recovery. 0 is poor condition and 10 is excellent condition. There are 5 assessment items (able to move voluntary, breathing, consciousness, circulation (BP) and spO2) which are graded on a 0-2 point scale with 0 being poor and 2 being excellent.

Outcome measures

Measure	Neostigmine n=31 Participants Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=31 Participants Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)	109 minutes Interval 75.0 to 156.0	112 minutes Interval 77.0 to 158.0

Adverse Events

Neostigmine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sugammadex

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Neostigmine n=31 participants at risk Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose. Neostigmine: Neostigmine will be given for reversal of neuromuscular blockade.	Sugammadex n=31 participants at risk Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose. Sugammadex: Sugammadex will be given for reversal of neuromuscular blockade.
General disorders Fever	0.00% 0/31 • 24 hours	3.2% 1/31 • Number of events 1 • 24 hours
Blood and lymphatic system disorders Bleeding	6.5% 2/31 • Number of events 2 • 24 hours	0.00% 0/31 • 24 hours
Cardiac disorders Hypotension	0.00% 0/31 • 24 hours	3.2% 1/31 • Number of events 1 • 24 hours

Additional Information

Ramon Abola, Clinical Associate Professor

Stony Brook Medicine

Phone: 631-444-2975

Email: ramon.abola@stonybrookmedicine.edu

Results disclosure agreements

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