Trial Outcomes & Findings for A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo (NCT NCT03087513)

Results Overview

Changes in the amplitude of the Motor Evoked Potentials from the baseline in the first dorsal interosseous muscle at 3 minutes in sugammadex group compared to placebo group

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Baseline and 3 minutes after the study intervention

Results posted on

2020-06-17

Participant Flow

Between February 2018 and April 2019, 73 posterior cervical spine patients screened from the preoperative assessment clinic of Toronto Western Hospital to identify eligible patients. First participant was enrolled on March 2018 and the last participant was enrolled on April 2019.

40 participants received 10ml syringe containing Sugammadex (2mg/kg) in the first phase, followed by Placebo 10 ml in the second phase or 10ml syringe containing Placebo in the first phase, followed by 10 ml of Sugammadex (2mg/kg) in the second phase. Time interval of approximately 3 hours between initial and crossover arm. 2 Patients withdrawn

Participant milestones

Participant milestones
Measure	Initial Arm and Crossover Arm The study participants will receive either 10ml syringe containing Sugammadex (2mg/kg) or 10 ml Placebo 10 ml in the initial arm and in the crossover arm they will recieve the other drug ( sugammadex or Placebo) Washout period is 3 hours
First Intervention STARTED	40
First Intervention COMPLETED	40
First Intervention NOT COMPLETED	0
Second Intervention After 3 hr Washout STARTED	40
Second Intervention After 3 hr Washout COMPLETED	38
Second Intervention After 3 hr Washout NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Initial Arm and Crossover Arm The study participants will receive either 10ml syringe containing Sugammadex (2mg/kg) or 10 ml Placebo 10 ml in the initial arm and in the crossover arm they will recieve the other drug ( sugammadex or Placebo) Washout period is 3 hours
Second Intervention After 3 hr Washout Equipment malfunction	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Intervention n=38 Participants Initial Arm The study participants will receive10ml syringe containing Sugammadex (2mg/kg) in the first phase, followed by 10 ml of Placebo in the second phase. Cross-over Arm The study participants will receive10ml syringe containing Placebo in the first phase, followed by 10 ml of Sugammadex (2mg/kg) in the second phase.
Age, Customized Age	60.8 Years STANDARD_DEVIATION 11.1 • n=38 Participants
Sex: Female, Male Female	21 Participants n=38 Participants
Sex: Female, Male Male	17 Participants n=38 Participants
Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms Left FDI Sugammedex Group	544.4 micro volts n=38 Participants
Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms Left FDI Placebo Group	377.1 micro volts n=38 Participants
Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms Right FDI Sugammedex Group	439.6 micro volts n=38 Participants
Baseline Motor Evoked Potential amplitudes in both baseline and cross-over arms Right FDI Placebo Group	418.7 micro volts n=38 Participants

PRIMARY outcome

Timeframe: Baseline and 3 minutes after the study intervention

Population: Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous

Changes in the amplitude of the Motor Evoked Potentials from the baseline in the first dorsal interosseous muscle at 3 minutes in sugammadex group compared to placebo group

Outcome measures

Outcome measures
Measure	Sugammadex n=38 Participants The study participants will receive a 10 ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo 10 ml (0.9% normal saline) in the second phase.	Placebo n=38 Participants The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes Left FDI amplitude changes from baseline at 3 min	652.9 micro volts Interval 142.0 to 1650.0	20.6 micro volts Interval -183.5 to 297.5
Changes Motor Evoked Potentials (MEPs) Amplitude at 3 Minutes Right FDI amplitude changes from baseline at 3 min	2153.4 micro volts Interval 1400.0 to 4536.8	55 micro volts Interval -65.2 to 480.8

SECONDARY outcome

Timeframe: Baseline to 6 minutes

Population: Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous

Changes in the amplitude of the MEPs from the baseline in the first dorsal interosseous muscle at 6 minutes

Outcome measures

Outcome measures
Measure	Sugammadex n=38 Participants The study participants will receive a 10 ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo 10 ml (0.9% normal saline) in the second phase.	Placebo n=38 Participants The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
MEPs Amplitude Changes in Both Sugammadex and Placebo Groups Left FDI	646.4 micro volts Interval 253.1 to 1580.9	84.3 micro volts Interval -178.6 to 679.8
MEPs Amplitude Changes in Both Sugammadex and Placebo Groups Right FDI	1609.3 micro volts Interval 632.4 to 5535.7	201.9 micro volts Interval -0.525 to 760.7

SECONDARY outcome

Timeframe: Baseline to 9 minutes

Population: Data are presented as Median (IQR). MEP- Motor evoked potential, µV-microvolt, min-minute, 1Q- First quartile, 3Q-third quartile, FDI- first dorsal interosseous

Comparison of changes in MEP amplitudes from baseline at 9 minutes between sugammadex and placebo groups

Outcome measures

Outcome measures
Measure	Sugammadex n=38 Participants The study participants will receive a 10 ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo 10 ml (0.9% normal saline) in the second phase.	Placebo n=38 Participants The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
MEPs Amplitude Changes From Baseline at 9 Minutes Left FDI	894.9 micro volts Interval 234.1 to 2261.2	105.5 micro volts Interval -115.2 to 775.0
MEPs Amplitude Changes From Baseline at 9 Minutes Right FDI	1256.3 micro volts Interval 308.9 to 2533.1	337.2 micro volts Interval -17.5 to 2215.8

SECONDARY outcome

Timeframe: From 0 to 15 minutes

Number of patients moved and observed by the surgeon. From the study intervention to the surgeon observed patient movements

Outcome measures

Outcome measures
Measure	Sugammadex n=38 Participants The study participants will receive a 10 ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo 10 ml (0.9% normal saline) in the second phase.	Placebo n=38 Participants The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
Patient Movement	6 participants	0 participants

SECONDARY outcome

Timeframe: approximatelt 1 hour - 30 min during surgical exposure and 30 minutes during closure

Surgical grading of relaxation of the surgical field as per the Likert-4 point surgical grading of surgical field. During surgical exposure and closure.

Outcome measures

Outcome measures
Measure	Sugammadex n=38 Participants The study participants will receive a 10 ml syringe containing sugammadex (2mg/kg) in the first phase, followed by placebo 10 ml (0.9% normal saline) in the second phase.	Placebo n=38 Participants The study participants will receive a 10ml syringe containing placebo (0.9% normal saline) in the first phase, followed by sugammadex 10 ml (2mg/kg) in the second phase.
Surgical Grading of Relaxation of the Surgical Field Good or optimal condition	31 Participants	35 Participants
Surgical Grading of Relaxation of the Surgical Field Acceptable	6 Participants	3 Participants
Surgical Grading of Relaxation of the Surgical Field Poor	1 Participants	0 Participants

Adverse Events

Sugammadex Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Coordinator

Toronto Western Hospital/University Health Network

Phone: 416-603-5800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER