NCT03328312

Brief Summary

Reversal of rocuronium-induced neuromuscular block by the combination of low-doses of neostigmine plus sugammadex decreases the cost of anesthetic medications, while maintaining efficacy of reversal in obese patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2017

Shorter than P25 for early_phase_1

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

October 17, 2017

Last Update Submit

October 31, 2017

Conditions

Incidence of Postoperative Residual Curarization

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative residual curarization (PORC)

    Incidence of postoperative residual curarization (PORC) (defined as a train-of-four ratio, TOFR \<0.9) measured 15 min after administration of the reversal agent.

    24 hours

Secondary Outcomes (3)

  • Time

    24 hours

  • Bradycardia

    24 hours

  • Residual blockade

    24 hours

Study Arms (3)

Sugammadex

ACTIVE COMPARATOR

For reversal of rocuronium neuromuscular- block we will use Sugammadex

Drug: Sugammadex

neostigmine+atropine

PLACEBO COMPARATOR

For reversal of rocuronium neuromuscular- block we will use Neostigmine (Miostin®; Stigmosan®) 0.05 mg/kg and atropine 1 mg/ dose.

Drug: neostigmine+atropine

neostigmine+atropine+sugammadex

EXPERIMENTAL

For reversal of rocuronium neuromuscular- block we will use Neostigmine (Miostin®; Stigmosan®) 0.025 mg/kg and atropine 0.5 mg/dose followed within 3 min by Sugammadex 1 mg/kg.

Drug: neostigmine+atropine+sugammadex

Interventions

SugammadexDRUG

Time period from administration of the reversal agent to recovery of TOFR \>0.9

Sugammadex
neostigmine+atropineDRUG

Number and time of bradycardic episodes (HR\<60 bpm) as well as that of tachycardic episodes (HR\>100 bpm) before tracheal extubation

neostigmine+atropine
neostigmine+atropine+sugammadexDRUG

4\. Time of extubation

neostigmine+atropine+sugammadex

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective abdominal surgery
  • years of age
  • BMI 30-39.9 ( obese class I-II)
  • American Society of Anesthesiologists (ASA) physical status II.
  • Surgery scheduled for general anesthesia and tracheal intubation and planned extubation at the end of surgery
  • Surgical procedures with an anticipated length of at least 60 min.

You may not qualify if:

  • Emergency surgery
  • Patients unable to consent to study participation
  • Patients expected to be maintained on mechanical ventilation postoperatively
  • Contraindication to any of the study drugs
  • Patients with existing neuromuscular disease
  • Acute or chronic renal failure (GFR-EPI \<30 mL/min/1.73 m2)
  • Acute/chronic liver disease (Child-Pugh Score \>1)
  • Hyperkalemia (\> 5.3 mmol/l)
  • Pregnancy
  • History of stroke or ongoing paresis
  • Glaucoma
  • Breast feeding
  • Sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Caius Breazu, Md,PhD

    Iuliu Hatieganu University of medicine and pharmacy cluj-Napoca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Calin I Mitre, MD,PhD

CONTACT

004074157497cmitre2001@gmail.com

Caius M Breazu, MD,PhD

CONTACT

0040743010012csbreazu@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor MD,PhD

Study Record Dates

First Submitted

October 17, 2017

First Posted

November 1, 2017

Study Start

December 1, 2017

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

November 1, 2017

Record last verified: 2017-10