Trial Outcomes & Findings for Residual Curarization and Its Incidence at Tracheal Extubation (P08194) (NCT NCT01318382)

Last Updated: 2017-05-09

Results Overview

Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of \<0.9 is indicative of residual NMB.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

302 participants

Primary outcome timeframe

Up to 1 minute prior to tracheal extubation

Results posted on

2017-05-09

Participant Flow

Participants were recruited at 8 sites in Canada between June 2011 and May 2012.

Participant milestones

Participant milestones
Measure	TOF-Watch SX® All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from neuromuscular blockade (NMB) monitored by a TOF-Watch SX®.
Overall Study STARTED	302
Overall Study COMPLETED	289
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	TOF-Watch SX® All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from neuromuscular blockade (NMB) monitored by a TOF-Watch SX®.
Overall Study Physician Decision	2
Overall Study Device Malfunction	10
Overall Study Protocol Violation	1

Baseline Characteristics

Residual Curarization and Its Incidence at Tracheal Extubation (P08194)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TOF-Watch SX® n=302 Participants All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
Age, Continuous	47.1 years STANDARD_DEVIATION 13.46 • n=5 Participants
Sex: Female, Male Female	222 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 minute prior to tracheal extubation

Population: Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.

Outcome measures

Outcome measures
Measure	TOF-Watch SX® n=241 Participants All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation	56 percentage of participants Interval 49.7 to 62.3

SECONDARY outcome

Timeframe: Up to 2 minutes prior to PACU arrival

Population: The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.

Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of \<0.9 is indicative of residual NMB.

Outcome measures

Outcome measures
Measure	TOF-Watch SX® n=207 Participants All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)	44 percentage of participants Interval 37.7 to 50.2

SECONDARY outcome

Timeframe: Up to 1 minute prior to tracheal extubation

Population: The Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.

Outcome measures

Outcome measures
Measure	TOF-Watch SX® n=241 Participants All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation TOF Ratio <0.6	19.1 percentage of participants Interval 14.1 to 24.0
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation TOF Ratio ≥0.6 to <0.7	11.6 percentage of participants Interval 7.6 to 15.7
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation TOF Ratio ≥0.7 to <0.8	8.7 percentage of participants Interval 5.2 to 12.3
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation TOF Ratio ≥0.8 to <0.9	16.6 percentage of participants Interval 11.9 to 21.3
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation TOF Ratio ≥0.9	44.0 percentage of participants Interval 37.7 to 50.3

SECONDARY outcome

Timeframe: Up to 2 minutes prior to PACU arrival

Population: The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.

Outcome measures

Outcome measures
Measure	TOF-Watch SX® n=207 Participants All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU TOF Ratio <0.6	7.7 percentage of participants Interval 4.4 to 11.1
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU TOF Ratio ≥0.6 to <0.7	7.2 percentage of participants Interval 4.0 to 10.5
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU TOF Ratio ≥0.7 to <0.8	13.5 percentage of participants Interval 9.2 to 17.8
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU TOF Ratio ≥0.8 to <0.9	15.5 percentage of participants Interval 10.9 to 20.0
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU TOF Ratio ≥0.9	56.0 percentage of participants Interval 49.8 to 62.3

Adverse Events

TOF-Watch SX®

Serious events: 24 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TOF-Watch SX® n=302 participants at risk All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
Gastrointestinal disorders Ileus Paralytic	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Gastrointestinal disorders Nausea	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
General disorders Chest Pain	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
General disorders Oedema Peripheral	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
General disorders Pain	0.66% 2/302 • Number of events 2 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Infections and infestations Clostridial Infection	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Infections and infestations Wound Infection	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Injury, poisoning and procedural complications Anastomotic Leak	0.66% 2/302 • Number of events 2 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Injury, poisoning and procedural complications Postoperative Ileus	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Injury, poisoning and procedural complications Procedural Complication	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Injury, poisoning and procedural complications Wound Dehiscence	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Investigations Electrocardiogram T Wave Inversion	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Investigations Oxygen Saturation Decreased	0.99% 3/302 • Number of events 3 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Renal and urinary disorders Urinary Retention	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.66% 2/302 • Number of events 2 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.66% 2/302 • Number of events 2 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Surgical and medical procedures Explorative Laparotomy	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
Vascular disorders Hypovolaemic Shock	0.33% 1/302 • Number of events 1 • Through Day 1 (up to one day after surgery) The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to provide copies of abstracts or manuscripts for publication that report any results of the trial to the Sponsor 45 days prior to submission for publication or presentation.
Publication restrictions are in place

Restriction type: OTHER