NCT03381209

Brief Summary

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

December 17, 2017

Last Update Submit

December 20, 2017

Conditions

Muscle Relaxation

Keywords

Sugammadexmorbidly obese patientsbariatric surgeryneuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • Reversal Time

    Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

    5 minutes after sugammadex administration

Secondary Outcomes (2)

  • duration of stay in PACU

    60 minutes after admission to the PACU

  • Time need for Extubation

    10 minutes after sugammadex administration

Study Arms (3)

Group A

EXPERIMENTAL

Sugammadex given in a dose of 2mg/kg based on ideal body weight

Drug: Sugammadex

Group B

EXPERIMENTAL

Sugammadex given in a dose of 2mg/kg based on adjusted body weight

Drug: Sugammadex

Group C

EXPERIMENTAL

Sugammadex given in a dose of 2mg/kg based on actual body weight

Drug: Sugammadex

Interventions

SugammadexDRUG

sugammadex given based on 3 measurements of body weights

Also known as: bridion
Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients older than 18 years and under 45 years,
  • body mass index ≥ 40 kg/m2, with indication of bariatric surgery

You may not qualify if:

  • Patients with comorbid including: neuromuscular disease, renal impairment, and patients with difficult airway were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Walid Nofal, MD

    Anesthesiology department, Faculty of Medicine, Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology

Study Record Dates

First Submitted

December 17, 2017

First Posted

December 21, 2017

Study Start

June 10, 2017

Primary Completion

November 10, 2017

Study Completion

November 10, 2017

Last Updated

December 21, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)