Trial Outcomes & Findings for Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery (NCT NCT03112993)

NCT ID: NCT03112993

Last Updated: 2022-04-01

Results Overview

Speed of neuromuscular recovery in minutes measured by recovery of the T4:T1 ratio ≥ 0.9 (measured with a TOF-Watch SX)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Day 1

Results posted on

2022-04-01

Participant Flow

Recruitment Period First subject on study: 30/MAY/2017; Last subject off study: 14/AUG/2018. Locations: University Hospital and Missouri Orthopaedic Institute, University of Missouri, Columbia, Missouri, United States of America.

Participant milestones

Participant milestones
Measure	Sugammadex Group 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. sugammadex: once at the end of the surgery	Neostigmine Group 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery
Overall Study STARTED	19	21
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugammadex Group n=19 Participants 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. sugammadex: once at the end of the surgery	Neostigmine Group n=21 Participants 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery	Total n=40 Participants Total of all reporting groups
Age, Continuous	70.4 years STANDARD_DEVIATION 4.7 • n=39 Participants	71.2 years STANDARD_DEVIATION 4.8 • n=41 Participants	70.8 years STANDARD_DEVIATION 4.75 • n=35 Participants
Sex: Female, Male Female	9 Participants n=39 Participants	4 Participants n=41 Participants	13 Participants n=35 Participants
Sex: Female, Male Male	10 Participants n=39 Participants	17 Participants n=41 Participants	27 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) White	18 Participants n=39 Participants	20 Participants n=41 Participants	38 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
ASA Physical Status Classification ASA PS 2	8 Participants n=39 Participants	5 Participants n=41 Participants	13 Participants n=35 Participants
ASA Physical Status Classification ASA PS 3	11 Participants n=39 Participants	16 Participants n=41 Participants	27 Participants n=35 Participants
Duration of surgery	175 minutes STANDARD_DEVIATION 128 • n=39 Participants	196 minutes STANDARD_DEVIATION 96 • n=41 Participants	185.5 minutes STANDARD_DEVIATION 112 • n=35 Participants
End of surgery to administration of reversal (min)	5.5 minutes STANDARD_DEVIATION 2.0 • n=39 Participants	4.8 minutes STANDARD_DEVIATION 1.4 • n=41 Participants	5.15 minutes STANDARD_DEVIATION 1.7 • n=35 Participants

PRIMARY outcome

Timeframe: Day 1

Speed of neuromuscular recovery in minutes measured by recovery of the T4:T1 ratio ≥ 0.9 (measured with a TOF-Watch SX)

Outcome measures

Outcome measures
Measure	Sugammadex Group n=19 Participants 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. sugammadex: once at the end of the surgery	Neostigmine Group n=21 Participants 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery
Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade	3.9 Minutes Standard Deviation 2.2	26.29 Minutes Standard Deviation 17.51

PRIMARY outcome

Timeframe: Day 1

Difference in time from neuromuscular reversal to exit from OR was measured in minutes.

Outcome measures

Outcome measures
Measure	Sugammadex Group n=19 Participants 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. sugammadex: once at the end of the surgery	Neostigmine Group n=21 Participants 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery
Difference in Time From Neuromuscular Reversal to Exit From OR	3.9 minutes Standard Deviation 2.2	19.8 minutes Standard Deviation 13.8

SECONDARY outcome

Timeframe: Day 1

Difference in time from neuromuscular reversal to tracheal extubation was measured in minutes.

Outcome measures

Outcome measures
Measure	Sugammadex Group n=19 Participants 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. sugammadex: once at the end of the surgery	Neostigmine Group n=21 Participants 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery
Difference in Time From Neuromuscular Reversal to Tracheal Extubation	5.3 minutes Standard Deviation 2.5	23.6 minutes Standard Deviation 18.7

SECONDARY outcome

Timeframe: Day 1

Length of PACU stay measured in minutes.

Outcome measures

Outcome measures
Measure	Sugammadex Group n=19 Participants 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. sugammadex: once at the end of the surgery	Neostigmine Group n=21 Participants 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery
Difference in Length of Stay in PACU	81.4 minutes Standard Deviation 16.5	85.3 minutes Standard Deviation 29.5

OTHER_PRE_SPECIFIED outcome

Timeframe: From Day 1 up to 1 week, depending on individual recovery time

Time from end of anesthesia to the first subject ambulation in hours.

Outcome measures

Outcome measures
Measure	Sugammadex Group n=19 Participants 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. sugammadex: once at the end of the surgery	Neostigmine Group n=21 Participants 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery
Difference in Time to First Ambulation After Surgery	17.4 hours Standard Deviation 14.6	17.8 hours Standard Deviation 11.1

Adverse Events

Sugammadex Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Neostigmine Group

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sugammadex Group n=19 participants at risk 2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Sugammadex: once at the end of the surgery	Neostigmine Group n=21 participants at risk 50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. Neostigmine: once at the end of the surgery
Surgical and medical procedures ICU admission	0.00% 0/19 • Each subjects was assessed for all-cause mortality, serious adverse events, and other adverse events across their entire duration of study participation, which was the time a subject provided written informed consent until their inpatient hospital discharge following surgery. This time frame was on average 4 days. All-cause mortality, serious adverse events, and other adverse events were systematically assessed by study physician investigators through regular investigator assessment, and through review of subjects' electronic medical records during study participation.	4.8% 1/21 • Each subjects was assessed for all-cause mortality, serious adverse events, and other adverse events across their entire duration of study participation, which was the time a subject provided written informed consent until their inpatient hospital discharge following surgery. This time frame was on average 4 days. All-cause mortality, serious adverse events, and other adverse events were systematically assessed by study physician investigators through regular investigator assessment, and through review of subjects' electronic medical records during study participation.
Surgical and medical procedures Blood transfusion	5.3% 1/19 • Each subjects was assessed for all-cause mortality, serious adverse events, and other adverse events across their entire duration of study participation, which was the time a subject provided written informed consent until their inpatient hospital discharge following surgery. This time frame was on average 4 days. All-cause mortality, serious adverse events, and other adverse events were systematically assessed by study physician investigators through regular investigator assessment, and through review of subjects' electronic medical records during study participation.	9.5% 2/21 • Each subjects was assessed for all-cause mortality, serious adverse events, and other adverse events across their entire duration of study participation, which was the time a subject provided written informed consent until their inpatient hospital discharge following surgery. This time frame was on average 4 days. All-cause mortality, serious adverse events, and other adverse events were systematically assessed by study physician investigators through regular investigator assessment, and through review of subjects' electronic medical records during study participation.
Surgical and medical procedures Prolonged hospitalization	10.5% 2/19 • Each subjects was assessed for all-cause mortality, serious adverse events, and other adverse events across their entire duration of study participation, which was the time a subject provided written informed consent until their inpatient hospital discharge following surgery. This time frame was on average 4 days. All-cause mortality, serious adverse events, and other adverse events were systematically assessed by study physician investigators through regular investigator assessment, and through review of subjects' electronic medical records during study participation.	9.5% 2/21 • Each subjects was assessed for all-cause mortality, serious adverse events, and other adverse events across their entire duration of study participation, which was the time a subject provided written informed consent until their inpatient hospital discharge following surgery. This time frame was on average 4 days. All-cause mortality, serious adverse events, and other adverse events were systematically assessed by study physician investigators through regular investigator assessment, and through review of subjects' electronic medical records during study participation.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Boris Mraovic, MD, Professor of Clinical Anesthesiology

University of Missouri

Phone: 573-882-2568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place