NCT02930629

Brief Summary

The purpose of this study is to assess the incidence of residual block in patients arriving in the Post Anaesthetic Care Unit (PACU) following surgery, and in those who have received neuromuscular blocking drugs (muscle relaxants). Residual block (decreased motor function) due to residual levels of muscle relaxants is associated with increased morbidity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

October 10, 2016

Last Update Submit

April 27, 2017

Conditions

Keywords

Recovery Period, AnesthesiaNeuromuscular Monitoring

Outcome Measures

Primary Outcomes (1)

  • Evidence of residual block (train of four <0.9) after receiving neuromuscular block for anaesthesia for surgery

    Train of four is measured at the adductor pollicis using TOF Watch acceleromyography

    Within one hour of surgery

Interventions

For patients, on arriving in PACU after having had muscle relaxants during general anaesthesia * Two ECG electrodes will be placed 4 cm apart over the path of the ulnar nerve of the wrist after cleaning the skin with alcohol swabs. * The TOF force transducer will be placed on the volar aspect of the thumb. * The TOF Watch leads will be attached to the ECG electrodes. * A TOF stimulus will be applied: four twitches at 2Hz (every 0.5 seconds), each twitch lasting 0.2ms, and at a current of 50 mA. As far as possible, this will be done when patients are still slightly drowsy from the effects of anaesthesia. * Two TOF ratio will be elicited (two sets of four twitches 15 seconds apart), and an average of the two taken

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients 21 years old or older, who receive neuromuscular blocking drugs (muscle relaxants) as part of their anaesthesia for surgery, and who arrive in the postoperative anaesthesia care unit.

You may qualify if:

  • All patients 21 years old or older, who receive neuromuscular blocking drugs (muscle relaxants) as part of their anaesthesia for surgery.

You may not qualify if:

  • Patients who have neuromuscular disease
  • Patients for whom applying train-of-four (to detect residual block) monitoring on their ulnar nerves is not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

Related Publications (2)

  • Plaud B, Debaene B, Donati F, Marty J. Residual paralysis after emergence from anesthesia. Anesthesiology. 2010 Apr;112(4):1013-22. doi: 10.1097/ALN.0b013e3181cded07. No abstract available.

  • Brull SJ, Prielipp RC. Reversal of neuromuscular blockade: "identification friend or foe". Anesthesiology. 2015 Jun;122(6):1183-5. doi: 10.1097/ALN.0000000000000675. No abstract available.

Study Officials

  • Patrick Wong, MBBS FRCA

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Wong, MBBS FRCA

CONTACT

Ruban Poopalalingam, MBBS MMED

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

October 1, 2016

Primary Completion

August 18, 2017

Study Completion

August 18, 2017

Last Updated

May 1, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations