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CompletedNCT03515694Updated Feb 15, 2019

Minimal Optimal Dose of Sugammadex in Elective Surgery

A Phase 4 interventional study of Sugammadex Injection [Bridion] in Time of a TOF Ratio >0,9, sponsored by Erasme University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Erasme University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex

Read the detailed description

Design: monocentric, prospective, controlled, randomized, double-blind study Inclusion criteria: women and men> 18 years old, elective surgery, BMI \<30, patients giving consent to free and informed participation in writing;

Exclusion criteria:

  • minor patients;
  • Patients refusing to sign the consent;
  • Patients included in another protocol within 3 months;
  • Pregnant or lactating patients;
  • Patients with a history of allergy to Sugammadex;
  • Patients with known neuromuscular disease;
  • Patients with renal or hepatic impairment.

Course of the study :

  • 40 patients will be recruited at the time of the anesthesia consultation and randomized to double blind in 8 groups (the day before surgery)
  • All patients will benefit from general anesthesia. Anesthetic management

    (1- 3mg / kg / IV propofol, 0.2 μg / IV sufentanil, 0.6 mg / kg rocuronium and maintenance anesthesia with sevoflurane) will be standardized for all patients.

  • Upon administration of rocuronium the acceleromyography transducer will be attached to the distal phalanx of the thumb, and repeated TOF stimulation will be applied to the ulnar nerve wrist at intervals of 15 seconds. Neuromuscular monitoring is continued until the end of the anesthesia.
  • Once the first answer (1st twitch) appeared a dose of sugammadex will be administered according to the group whose patient was randomized: Test Groups Control Groups Group 1: Placebo + TOF 1 Group 1bis: Placebo + TOF2 Group 2: 0.5 mg / kg + TOF1 Group 2bis: 0.5 mg / kg + TOF2 Group 3: 1mg / kg + TOF1 Group 3bis: 1mg / kg + TOF2 Group 4: 2mg / kg + TOF 1 Group 4bis: 2mg / kg + TOF 2
  • Then a standard dose of 4mg / kg will be administered at the end of the procedure before awakening to all patients who have signs of residual curarization (TOF ratio \<0.9). The pharmacy will be responsible for preparing the different doses of sugammadex, the syringe will be carefully covered and packaged, will contain an equal volume so that the anesthetists do not know which group the patient belongs to. Data collection: In real time during the intervention by the anesthesiologist in charge of patient Method of Analysis: Analysis of intent-to-treat data
02

Conditions studied

  • Time of a TOF Ratio >0,9

Keywords

  • Bridion
  • Sugammadex
  • TOF
03

In context

Lead sponsor

Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

women and men> 18 years of age Elective Surgery BMI \<30, patients who gave consent to free and informed participation in writing

Exclusion criteria

Exclusion Criteria:

  • minor patients;
  • patients refusing to sign consent;
  • patients included in another protocol within 3 months;
  • pregnant or nursing patients;
  • patients with a history of allergy to Sugammadex;
  • patients with known neuromuscular disease
  • patients with renal or hepatic impairment.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    Dose of 0mg/kg TOF1

    Drug: Sugammadex Injection [Bridion]

  • Placebo comparator
    Dose of 0mg/kg TOF2

    Drug: Sugammadex Injection [Bridion]

  • Experimental
    Dose of 0 ,5mg/kg TOF1

    Drug: Sugammadex Injection [Bridion]

  • Active comparator
    Dose of 0,5mg/kg TOF2

    Drug: Sugammadex Injection [Bridion]

  • Experimental
    Dose of 1mg/kg TOF1

    Drug: Sugammadex Injection [Bridion]

  • Active comparator
    Dose of 1mg/kg TOF2

    Drug: Sugammadex Injection [Bridion]

  • Experimental
    Dose of 2mg/kg TOF1

    Drug: Sugammadex Injection [Bridion]

  • Active comparator
    Dose of 2mg/kg TOF2

    Drug: Sugammadex Injection [Bridion]

Interventions

  • DrugSugammadex Injection [Bridion]

    Injection of 10mL of translucide solution

06

What researchers measure

Primary outcomes

  1. Evaluate the recovery time of the ratio 0.9.

    Evaluate the recovery time of the ratio 0.9.

    Time frame: 1 hour

Secondary outcomes

  1. Time of appearance of 4 responses to the TOF

    Time of appearance of 4 responses to the TOF

    Time frame: 1 hour

  2. Evaluate the four-to-four ratio <0.7 after total recovery.

    Evaluate the four-to-four ratio \<0.7 after total recovery.

    Time frame: 1 hour

  3. Watch time at the recovery room.

    Watch time at the recovery room.

    Time frame: 4 hours

07

Study locations

1 site
  • Hopital Erasme
    Bruxelles, 1070, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03515694
Lead sponsor
Erasme University Hospital
Responsible party
Sponsor
First posted
May 3, 2018
Start date
Apr 3, 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Last update
Feb 15, 2019

Study contacts

Wendy FERNANDEZ, Resident
principal investigator · Erasme University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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