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Residual Curarization and Its Incidence at Tracheal Extubation (P08194) (RECITE)

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ClinicalTrials.gov Identifier: NCT01318382
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : May 22, 2013
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Observation of Neuromuscular Block
Intervention Device: TOF-Watch SX® Monitoring of NMB
Enrollment 302
Recruitment Details Participants were recruited at 8 sites in Canada between June 2011 and May 2012.
Pre-assignment Details  
Arm/Group Title TOF-Watch SX®
Hide Arm/Group Description 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®.
Period Title: Overall Study
Started 302
Completed 289
Not Completed 13
Reason Not Completed
Physician Decision             2
Device Malfunction             10
Protocol Violation             1
Arm/Group Title TOF-Watch SX®
Hide Arm/Group Description 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®.
Overall Number of Baseline Participants 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 302 participants
47.1  (13.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants
Female
222
  73.5%
Male
80
  26.5%
1.Primary Outcome
Title Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
Hide Description 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.
Time Frame Up to 1 minute prior to tracheal extubation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TOF-Watch SX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(49.7 to 62.3)
2.Secondary Outcome
Title Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)
Hide Description 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.
Time Frame Up to 2 minutes prior to PACU arrival
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TOF-Watch SX®
Hide Arm/Group Description:
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 PACU arrival.
Overall Number of Participants Analyzed 207
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44
(37.7 to 50.2)
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Up to 1 minute prior to tracheal extubation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TOF-Watch SX®
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TOF Ratio <0.6
19.1
(14.1 to 24.0)
TOF Ratio ≥0.6 to <0.7
11.6
(7.6 to 15.7)
TOF Ratio ≥0.7 to <0.8
8.7
(5.2 to 12.3)
TOF Ratio ≥0.8 to <0.9
16.6
(11.9 to 21.3)
TOF Ratio ≥0.9
44.0
(37.7 to 50.3)
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Up to 2 minutes prior to PACU arrival
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TOF-Watch SX®
Hide Arm/Group Description:
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 PACU arrival.
Overall Number of Participants Analyzed 207
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
TOF Ratio <0.6
7.7
(4.4 to 11.1)
TOF Ratio ≥0.6 to <0.7
7.2
(4.0 to 10.5)
TOF Ratio ≥0.7 to <0.8
13.5
(9.2 to 17.8)
TOF Ratio ≥0.8 to <0.9
15.5
(10.9 to 20.0)
TOF Ratio ≥0.9
56.0
(49.8 to 62.3)
Time Frame Through Day 1 (up to one day after surgery)
Adverse Event Reporting Description The All Enrolled Participants population consisted of all participants meeting eligibility criteria who were enrolled into the study.
 
Arm/Group Title TOF-Watch SX®
Hide Arm/Group Description 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®.
All-Cause Mortality
TOF-Watch SX®
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TOF-Watch SX®
Affected / at Risk (%) # Events
Total   24/302 (7.95%)    
Gastrointestinal disorders   
Ileus Paralytic  1/302 (0.33%)  1
Nausea  1/302 (0.33%)  1
General disorders   
Chest Pain  1/302 (0.33%)  1
Oedema Peripheral  1/302 (0.33%)  1
Pain  2/302 (0.66%)  2
Infections and infestations   
Clostridial Infection  1/302 (0.33%)  1
Wound Infection  1/302 (0.33%)  1
Injury, poisoning and procedural complications   
Anastomotic Leak  2/302 (0.66%)  2
Postoperative Ileus  1/302 (0.33%)  1
Procedural Complication  1/302 (0.33%)  1
Wound Dehiscence  1/302 (0.33%)  1
Investigations   
Electrocardiogram T Wave Inversion  1/302 (0.33%)  1
Oxygen Saturation Decreased  3/302 (0.99%)  3
Renal and urinary disorders   
Urinary Retention  1/302 (0.33%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  2/302 (0.66%)  2
Hypoxia  1/302 (0.33%)  1
Pleural Effusion  1/302 (0.33%)  1
Pneumonia Aspiration  1/302 (0.33%)  1
Pulmonary Embolism  2/302 (0.66%)  2
Surgical and medical procedures   
Explorative Laparotomy  1/302 (0.33%)  1
Vascular disorders   
Hypovolaemic Shock  1/302 (0.33%)  1
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TOF-Watch SX®
Affected / at Risk (%) # Events
Total   0/302 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01318382     History of Changes
Other Study ID Numbers: P08194
MK-8616-063 ( Other Identifier: Merck Protocol ID )
First Submitted: March 17, 2011
First Posted: March 18, 2011
Results First Submitted: April 4, 2013
Results First Posted: May 22, 2013
Last Update Posted: May 9, 2017