Neuromuscular BlockadeINSPIRENCT01181349

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

An observational study of Neuromuscular Blockade, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuromuscular Blockade
What is being tested?: Neuromuscular Blocking Agent (NMBA)
How many people: 350 participants
Where: No sites listed yet
Study dates: Jul 2010to Nov 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult Portuguese participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents

Who may be able to join

18 years of age or older
Informed consent signed
Admission for elective surgery
Administration of nondepolarizing NMBAs during surgery

Who cannot join

Admission for emergency surgery
Reoperation on the same hospital admission

About this study

Official title: Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal

This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia. During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital discharge data from the participants will be collected. The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.

Conditions: Neuromuscular Blockade
Being tested: Neuromuscular Blocking Agent (NMBA)
Keywords: neuromuscular blockade; general anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuromuscular Blocking Agent (NMBA)Other
While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.
Neuromuscular Blocking Agent (NMBA)Other
While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.

Study groups in NCT01181349
Study group	Role	What they receive
P07535 study participants with a TOF ratio <0.9		Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio <0.9 at PACU arrival. Receives: Other: Neuromuscular Blocking Agent (NMBA)
P07535 study participants with a TOF ratio ≥0.9		Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio ≥0.9 at PACU arrival. Receives: Other: Neuromuscular Blocking Agent (NMBA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival
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).
Measured: Upon arrival in the PACU

Secondary outcomes (4)

Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents
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.
Measured: From start of surgery through PACU arrival
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane
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.
Measured: From start of surgery through PACU arrival
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents
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.
Measured: From end of surgery through PACU arrival, an expected average of 10 minutes
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events
Measured: From end of surgery through hospital discharge, an expected average of 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Nov 2010

First posted13 Aug 2010 (estimated)
Study startJul 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01181349
Sponsor's protocol ID: P07535
Acronym: INSPIRE
Status last verified: Oct 2015
First submitted: 23 Jul 2010
Last updated: 14 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Esteves S, Martins M, Barros F, Barros F, Canas M, Vitor P, Seabra M, Castro MM, Bastardo I. Incidence of postoperative residual neuromuscular blockade in the postanaesthesia care unit: an observational multicentre study in Portugal. Eur J Anaesthesiol. 2013 May;30(5):243-9. doi: 10.1097/EJA.0b013e32835dccd7.
PubMed 23344123

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
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The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal
ClinicalTrials.gov ID: NCT01181349
Acronym / sponsor ID: INSPIRE / P07535
Conditions: Neuromuscular Blockade
Keywords: neuromuscular blockade; general anesthesia
Study type: Observational
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 2 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Number of arms: 2

Arm	Type	Receives
P07535 study participants with a TOF ratio <0.9	–	Other: Neuromuscular Blocking Agent (NMBA)Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio <0.9 at PACU arrival.
P07535 study participants with a TOF ratio ≥0.9	–	Other: Neuromuscular Blocking Agent (NMBA)Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio ≥0.9 at PACU arrival.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult Portuguese participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents

Key inclusion criteria (4 listed)

18 years of age or older
Informed consent signed
Admission for elective surgery
Administration of nondepolarizing NMBAs during surgery

Key exclusion criteria (2 listed)

Admission for emergency surgery
Reoperation on the same hospital admission

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neuromuscular Blocking Agent (NMBA)While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.	Other	P07535 study participants with a TOF ratio <0.9
Neuromuscular Blocking Agent (NMBA)While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.	Other	P07535 study participants with a TOF ratio ≥0.9

Primary outcome

Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival
Time frame: Upon arrival in the PACU
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).

4 secondary outcomes

Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents
Time frame: From start of surgery through PACU arrival
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane
Time frame: From start of surgery through PACU arrival
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents
Time frame: From end of surgery through PACU arrival, an expected average of 10 minutes
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events
Time frame: From end of surgery through hospital discharge, an expected average of 6 days

Results and safety

Results posted to the registry on 2 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	350	350

Primary outcome: Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival

Time frame: Upon arrival in the PACU. Number. Unit: participants

Measure	All Participants n = 350
Value	91

Population analysed: Full analysis set (FAS) population includes all treated participants

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	3 of 350 (0.9%)	0 of 350 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23344123Esteves S, Martins M, Barros F, Barros F, Canas M, Vitor P, Seabra M, Castro MM, Bastardo I. Incidence of postoperative residual neuromuscular blockade in the postanaesthesia care unit: an observational multicentre study in Portugal. Eur J Anaesthesiol. 2013 May;30(5):243-9. doi: 10.1097/EJA.0b013e32835dccd7.

Related trials for Neuromuscular Blockade

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Neuromuscular Blockade, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival (time frame: Upon arrival in the PACU). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01181349, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.