Residual Paralysis, Post-AnesthesiaNCT01718860
Effects of Postoperative Residual Paralysis on Hospital Costs
An observational study of Residual Paralysis, Post-Anesthesia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a secondary analysis of a previously performed prospective, observer-blinded, observational study at Massachusetts General Hospital. The primary aim of this study is to evaluate the effects of residual paralysis at admission to the post-anesthesia care unit (PACU) on total costs of hospital care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Paralysis, Post-Anesthesia
- What is being tested?
- Quantitative measurement of neuromuscular transmission
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 patients who arrived at the post-anesthesia care unit after receiving neuromuscular blocking agents as part of their surgical anaesthesia.
Who may be able to join
- Each subject has been given non-depolarizing neuromuscular blocking agents as part of general anesthesia.
- Each subject must be at least 18 years of age
- Train-of-four monitoring in the post-anesthesia care unit
Who cannot join
- The subject is scheduled to be transferred to an intensive care unit after surgery.
- Children and pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effects of Postoperative Residual Paralysis on Costs of Hospital Care, Length of Hospitalization and Intensive Care Unit Admission Rate
This is a secondary analysis of a previously performed prospective, observer-blinded, observational study at Massachusetts General Hospital. The primary aim of this study is to evaluate the effects of residual paralysis at admission to the post-anesthesia care unit (PACU) on total costs of hospital care.
Secondary analyses will be conducted to evaluate the effects of postoperative residual paralysis on potential cost-influencing factors, i.e. incidence of minor and major postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive care unit (ICU) admission rate, as well as length of stay in the PACU.
- Conditions
- Residual Paralysis, Post-Anesthesia
- Being tested
- Quantitative measurement of neuromuscular transmission
- Keywords
- Cost Analysis, Postoperative Complications, Length of Stay, Intensive Care Units
- Medical subject headings
- Delayed Emergence from Anesthesia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative measurement of neuromuscular transmissionProcedure or surgery
Quantitative measurement of neuromuscular transmission with train-of-four watches.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Residual Paralysis | Patients with train-of-four ratio less than 0.9 measured in the postanesthesia care unit Receives: Procedure: Quantitative measurement of neuromuscular transmission | |
| No Postoperative Residual Paralysis | Patients with train-of-four ratio greater than 0.9 measured in the postanesthesia care unit Receives: Procedure: Quantitative measurement of neuromuscular transmission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital costs
Measured: Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks
Secondary outcomes (1)
Hospital Length of Stay
Measured: within 100 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Residual Paralysis, Post-AnesthesiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Matthias Eikermann, Massachusetts General Hospital
- Investigators
- Matthias Eikermann, MD, PhD, Principal investigator, Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718860
- Sponsor's protocol ID
- 2016P002695
- Other IDs
- IISP#39443
- Status last verified
- May 2017
- First submitted
- 29 Oct 2012
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24.
PubMed 20576632Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d.
PubMed 20980910Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
PubMed 18635478Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
PubMed 9366929Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329.
PubMed 23077290Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440.
PubMed 25225821Grabitz SD, Rajaratnam N, Chhagani K, Thevathasan T, Teja BJ, Deng H, Eikermann M, Kelly BJ. The Effects of Postoperative Residual Neuromuscular Blockade on Hospital Costs and Intensive Care Unit Admission: A Population-Based Cohort Study. Anesth Analg. 2019 Jun;128(6):1129-1136. doi: 10.1213/ANE.0000000000004028.
PubMed 31094777
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postoperative Residual Paralysis on Costs of Hospital Care, Length of Hospitalization and Intensive Care Unit Admission Rate
- ClinicalTrials.gov ID
- NCT01718860
- Acronym / sponsor ID
- 2016P002695
- Conditions
- Residual Paralysis, Post-Anesthesia
- Keywords
- Cost Analysis, Postoperative Complications, Length of Stay, Intensive Care Units
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a secondary analysis of a previously performed prospective, observer-blinded, observational study at Massachusetts General Hospital. The primary aim of this study is to evaluate the effects of residual paralysis at admission to the post-anesthesia care unit (PACU) on total costs of hospital care.
Secondary analyses will be conducted to evaluate the effects of postoperative residual paralysis on potential cost-influencing factors, i.e. incidence of minor and major postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive care unit (ICU) admission rate, as well as length of stay in the PACU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative Residual Paralysis | – | Procedure: Quantitative measurement of neuromuscular transmissionPatients with train-of-four ratio less than 0.9 measured in the postanesthesia care unit |
| No Postoperative Residual Paralysis | – | Procedure: Quantitative measurement of neuromuscular transmissionPatients with train-of-four ratio greater than 0.9 measured in the postanesthesia care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who arrived at the post-anesthesia care unit after receiving neuromuscular blocking agents as part of their surgical anaesthesia.
Key inclusion criteria (3 listed)
- Each subject has been given non-depolarizing neuromuscular blocking agents as part of general anesthesia.
- Each subject must be at least 18 years of age
- Train-of-four monitoring in the post-anesthesia care unit
Key exclusion criteria (2 listed)
- The subject is scheduled to be transferred to an intensive care unit after surgery.
- Children and pregnant women
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 |
|---|---|---|
| Quantitative measurement of neuromuscular transmissionQuantitative measurement of neuromuscular transmission with train-of-four watches. | Procedure or surgery | No Postoperative Residual Paralysis, Postoperative Residual Paralysis |
Primary outcome
Hospital costs
Time frame: Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks
1 secondary outcome
Hospital Length of Stay
Time frame: within 100 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Background: PubMed 20576632Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24.
- Background: PubMed 20980910Herbstreit F, Zigrahn D, Ochterbeck C, Peters J, Eikermann M. Neostigmine/glycopyrrolate administered after recovery from neuromuscular block increases upper airway collapsibility by decreasing genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2010 Dec;113(6):1280-8. doi: 10.1097/ALN.0b013e3181f70f3d.
- Background: PubMed 18635478Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
- Background: PubMed 9366929Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
- Background: PubMed 23077290Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329.
- Background: PubMed 25225821Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440.
- Derived from this study: PubMed 31094777Grabitz SD, Rajaratnam N, Chhagani K, Thevathasan T, Teja BJ, Deng H, Eikermann M, Kelly BJ. The Effects of Postoperative Residual Neuromuscular Blockade on Hospital Costs and Intensive Care Unit Admission: A Population-Based Cohort Study. Anesth Analg. 2019 Jun;128(6):1129-1136. doi: 10.1213/ANE.0000000000004028.
- Individual participant dataSharing planned: No
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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.
Matthias Eikermann, MD, PhD principal investigator
Partners
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Residual Paralysis, Post-Anesthesia, run by Massachusetts General Hospital at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Hospital costs (time frame: Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks). 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 NCT01718860, which also lists 7 linked publications.
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 4 May 2017.