NCT03551652

Brief Summary

Elderly people, especially geriatric patients, account for a growing share of patients receiving anesthesia. In patients over 75 years of age the annual rate of anesthesia represents 16.8 / 100 inhabitants for women and 19.6 / 100 for men. It is a growing population, but also the most fragile population with a mortality amounting to 44.4 / 10000 anesthesia. After 85 years, one out of every two patients is ASA 3 or older. The first cause of death related to anesthesia today remains respiratory complications, particularly infectious. This is a major public health issue right now. The studies on the use of curare and particularly rocuronium are old and did not study a population of elderly people (with an average age of 70 years). Several studies show an increase in the duration of neuromuscular blockade in patients older than 70 years irrespective of any renal failure, with sometimes persistent curarizations more than 2h after a single dose. But no study to date has studied the duration of deep-intensity neuromuscular block (TOF).

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
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

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

First Submitted

Initial submission to the registry

May 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
1.9 years until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

February 1, 2021

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

May 29, 2018

Last Update Submit

January 28, 2021

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Total time of neuromuscular block

    Time from rocuronium injection to total recovery of neuromuscular block

    4 hours, during surgery

Secondary Outcomes (5)

  • Deep neuromuscular block

    4 hours, during surgery

  • Recovery time 0.9

    4 hours, during surgery

  • Recovery time 1.0

    4 hours, during surgery

  • Recovery time 0.9 Tref

    4 hours, during surgery

  • Recovery time 1.0 Tref

    4 hours, during surgery

Study Arms (2)

Young patients

Patients aged 18 - 50 years

Drug: Pharmacokinetics of rocuronium induced neuromuscular block

Geriatric patients

Patients aged ≥ 80 years

Drug: Pharmacokinetics of rocuronium induced neuromuscular block

Interventions

Pharmacokinetics of rocuronium induced neuromuscular blockDRUG

Measurement of rocuronium induced neuromuscular block comparing patients aged \> 80 years with patients aged 18 to 50 years

Geriatric patientsYoung patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged between 18-50 years or \> 80 years, undergoing surgery with neuromuscular block induced by rocuronium

You may qualify if:

  • Patients scheduled for surgery with neuromuscular blockade by rocuronium
  • Body mass index between 18.5 and 35
  • Age 18 - 50 years or age \> 80 years

You may not qualify if:

  • Known allergy to rocuronium
  • rapid sequence induction
  • clinical hepatocellular insufficiency
  • renal insufficiency requiring dialysis
  • ASA class \> 2 in the group 18-50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, 54450, France

RECRUITING

Related Publications (13)

  • Klopfenstein CE, Herrmann FR, Michel JP, Clergue F, Forster A. The influence of an aging surgical population on the anesthesia workload: a ten-year survey. Anesth Analg. 1998 Jun;86(6):1165-70. doi: 10.1097/00000539-199806000-00005.

    PMID: 9620497BACKGROUND

  • Auroy Y, Laxenaire MC, Clergue F, Pequignot F, Jougla E, Lienhart A. [Anesthetics according to characteristics of patients, establishments and indications]. Ann Fr Anesth Reanim. 1998;17(11):1311-6. doi: 10.1016/s0750-7658(99)80043-4. No abstract available. French.

    PMID: 9972358BACKGROUND

  • Forrest JB, Rehder K, Cahalan MK, Goldsmith CH. Multicenter study of general anesthesia. III. Predictors of severe perioperative adverse outcomes. Anesthesiology. 1992 Jan;76(1):3-15. doi: 10.1097/00000542-199201000-00002.

    PMID: 1729933BACKGROUND

  • Pignaton W, Braz JRC, Kusano PS, Modolo MP, de Carvalho LR, Braz MG, Braz LG. Perioperative and Anesthesia-Related Mortality: An 8-Year Observational Survey From a Tertiary Teaching Hospital. Medicine (Baltimore). 2016 Jan;95(2):e2208. doi: 10.1097/MD.0000000000002208.

    PMID: 26765400BACKGROUND

  • Tiret L, Desmonts JM, Hatton F, Vourc'h G. Complications associated with anaesthesia--a prospective survey in France. Can Anaesth Soc J. 1986 May;33(3 Pt 1):336-44. doi: 10.1007/BF03010747.

    PMID: 3719435BACKGROUND

  • Yamamoto H, Uchida T, Yamamoto Y, Ito Y, Makita K. Retrospective analysis of spontaneous recovery from neuromuscular blockade produced by empirical use of rocuronium. J Anesth. 2011 Dec;25(6):845-9. doi: 10.1007/s00540-011-1229-x. Epub 2011 Sep 21.

    PMID: 21935686BACKGROUND

  • Comparison of Neuromuscular Blockade with Rocuronium in Young and Elderly Patients with or without Renal Failure. 1SK Gvalani, 2L Pradeep Research & Innovation in Anesthesia, July-December 2016;1(2):45-51

    BACKGROUND

  • Bevan DR, Fiset P, Balendran P, Law-Min JC, Ratcliffe A, Donati F. Pharmacodynamic behaviour of rocuronium in the elderly. Can J Anaesth. 1993 Feb;40(2):127-32. doi: 10.1007/BF03011309.

    PMID: 8443851BACKGROUND

  • Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Parikh KN, Patel SS, Patel A. Residual Neuromuscular Block in the Elderly: Incidence and Clinical Implications. Anesthesiology. 2015 Dec;123(6):1322-36. doi: 10.1097/ALN.0000000000000865.

    PMID: 26448469BACKGROUND

  • Arain SR, Kern S, Ficke DJ, Ebert TJ. Variability of duration of action of neuromuscular-blocking drugs in elderly patients. Acta Anaesthesiol Scand. 2005 Mar;49(3):312-5. doi: 10.1111/j.1399-6576.2005.00634.x.

    PMID: 15752394BACKGROUND

  • Kocabas S, Yedicocuklu D, Askar FZ. The neuromuscular effects of 0.6 mg kg(-1) rocuronium in elderly and young adults with or without renal failure. Eur J Anaesthesiol. 2008 Nov;25(11):940-6. doi: 10.1017/S0265021508004717. Epub 2008 Jun 9.

    PMID: 18538050BACKGROUND

  • Neuromuskuläres Monitoring in Klinik und Forschung. T. Fuchs-Buder, Springer Medezin Verlag, 2008, ISBN 978-3-540-78569-9

    BACKGROUND

  • Schmartz D, Sghaier R, Bernard P, Fils JF, Fuchs-Buder T. Neuromuscular block in patients 80 years and older: a prospective, controlled study. BMC Anesthesiol. 2021 Sep 13;21(1):225. doi: 10.1186/s12871-021-01443-1.

    PMID: 34517841DERIVED

Study Officials

  • Thomas Fuchs-Buder, MD, PhD

    CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Fuchs-Buder, MD, PhD

CONTACT

+33383154166t.fuchs-buder@chru-nancy.fr

Study Design

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

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 11, 2018

Study Start

May 15, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

February 1, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)