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

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

• Study Type: Interventional
• Study Design: Allocation: N/A; 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

Participant Flow

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®
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

Baseline Characteristics

Arm/Group Title		TOF-Watch SX®
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
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%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
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

Outcome Measure Data

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®
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)
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

Outcome Measure Data

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®
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
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

Outcome Measure Data

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®
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
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

Outcome Measure Data

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®
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)

Adverse Events

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®
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	--/--
Serious Adverse Events
	TOF-Watch SX®
	Affected / at Risk (%)	# Events
Total	24/302 (7.95%)
Gastrointestinal disorders
Ileus Paralytic 1	1/302 (0.33%)	1
Nausea 1	1/302 (0.33%)	1
General disorders
Chest Pain 1	1/302 (0.33%)	1
Oedema Peripheral 1	1/302 (0.33%)	1
Pain 1	2/302 (0.66%)	2
Infections and infestations
Clostridial Infection 1	1/302 (0.33%)	1
Wound Infection 1	1/302 (0.33%)	1
Injury, poisoning and procedural complications
Anastomotic Leak 1	2/302 (0.66%)	2
Postoperative Ileus 1	1/302 (0.33%)	1
Procedural Complication 1	1/302 (0.33%)	1
Wound Dehiscence 1	1/302 (0.33%)	1
Investigations
Electrocardiogram T Wave Inversion 1	1/302 (0.33%)	1
Oxygen Saturation Decreased 1	3/302 (0.99%)	3
Renal and urinary disorders
Urinary Retention 1	1/302 (0.33%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea 1	2/302 (0.66%)	2
Hypoxia 1	1/302 (0.33%)	1
Pleural Effusion 1	1/302 (0.33%)	1
Pneumonia Aspiration 1	1/302 (0.33%)	1
Pulmonary Embolism 1	2/302 (0.66%)	2
Surgical and medical procedures
Explorative Laparotomy 1	1/302 (0.33%)	1
Vascular disorders
Hypovolaemic Shock 1	1/302 (0.33%)	1
1 Term from vocabulary, MedDRA 15.0
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%)

Limitations and Caveats

[Not Specified]

More Information

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.
• EMail: ClinicalTrialsDisclosure@merck.com

Publications of Results:

Fortier LP, McKeen D, Turner K, de Médicis É, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT01318382
• 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