Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed) (INSPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181349
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : April 2, 2012
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort
Condition Neuromuscular Blockade
Intervention Other: Neuromuscular Blocking Agent (NMBA)
Enrollment 350
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description

Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia

with neuromuscular blocking agents

Period Title: Overall Study
Started 350
Completed 350
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description

Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia

with neuromuscular blocking agents

Overall Number of Baseline Participants 350
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 350 participants
54.3  (15.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 350 participants
Female
216
  61.7%
Male
134
  38.3%
1.Primary Outcome
Title Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival
Hide Description The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio <0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).
Time Frame Upon arrival in the PACU
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population includes all treated participants
Arm/Group Title All Participants
Hide Arm/Group Description:

Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia

with neuromuscular blocking agents

Overall Number of Participants Analyzed 350
Measure Type: Number
Unit of Measure: participants
91
2.Secondary Outcome
Title Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents
Hide Description Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.
Time Frame From start of surgery through PACU arrival
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population includes all treated participants; for this outcome measure only participants who received atracurium, cisatracurium, rocuronium or vecuronium are included
Arm/Group Title P07535 Study Participants With a TOF Ratio <0.9 P07535 Study Participants With a TOF Ratio ≥0.9
Hide Arm/Group Description:
Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Overall Number of Participants Analyzed 87 250
Measure Type: Number
Unit of Measure: participants
Participants Receiving Atracurium 13 42
Participants Receiving Cisatracurium 35 73
Participants Receiving Rocuronium 31 118
Participants Receiving Vecuronium 8 17
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P07535 Study Participants With a TOF Ratio <0.9, P07535 Study Participants With a TOF Ratio ≥0.9
Comments Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher’s Exact Test. All tests were performed at a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.169
Comments [Not Specified]
Method Chi-square test or Fisher's Exact Test
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane
Hide Description Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.
Time Frame From start of surgery through PACU arrival
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population includes all treated participants; for this outcome measure only participants who received propofol or sevoflurane are included
Arm/Group Title P07535 Study Participants With a TOF Ratio <0.9 P07535 Study Participants With a TOF Ratio ≥0.9
Hide Arm/Group Description:
Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Overall Number of Participants Analyzed 64 193
Measure Type: Number
Unit of Measure: participants
Participants Receiving Propofol 60 169
Participants Receiving Sevoflurane 4 24
4.Secondary Outcome
Title Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents
Hide Description Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.
Time Frame From end of surgery through PACU arrival, an expected average of 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population includes all treated participants
Arm/Group Title P07535 Study Participants With a TOF Ratio <0.9 P07535 Study Participants With a TOF Ratio ≥0.9
Hide Arm/Group Description:
Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Overall Number of Participants Analyzed 91 259
Measure Type: Number
Unit of Measure: participants
71 162
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection P07535 Study Participants With a TOF Ratio <0.9, P07535 Study Participants With a TOF Ratio ≥0.9
Comments Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher’s Exact Test. All tests were performed at a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.01
Comments [Not Specified]
Method Chi-square test or Fisher's Exact Test
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events
Hide Description [Not Specified]
Time Frame From end of surgery through hospital discharge, an expected average of 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population includes all treated participants
Arm/Group Title P07535 Study Participants With a TOF Ratio <0.9 P07535 Study Participants With a TOF Ratio ≥0.9
Hide Arm/Group Description:
Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Overall Number of Participants Analyzed 91 259
Measure Type: Number
Unit of Measure: participants
12 21
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description

Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia

with neuromuscular blocking agents

All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   3/350 (0.86%)    
Gastrointestinal disorders   
peritoneal haemorrhage  1/350 (0.29%)  1
Infections and infestations   
septic shock  1/350 (0.29%)  1
Respiratory, thoracic and mediastinal disorders   
respiratory insufficiency  1/350 (0.29%)  1
acute respiratory distress syndrome  1/350 (0.29%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants
Affected / at Risk (%) # Events
Total   0/350 (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.
Investigator may not publish/publicly present interim results without prior consent of Sponsor. Any materials that report results of the study must be sent to Sponsor 45 days prior to submission for publication/presentation. Sponsor has right to review and comment. In case of any disagreements concerning appropriateness of the materials, investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues or disagreement, prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181349    
Other Study ID Numbers: P07535
First Submitted: July 23, 2010
First Posted: August 13, 2010
Results First Submitted: February 29, 2012
Results First Posted: April 2, 2012
Last Update Posted: October 14, 2015