NCT02713113

Brief Summary

the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

March 15, 2016

Last Update Submit

March 18, 2016

Conditions

Bariatric Patients

Outcome Measures

Primary Outcomes (1)

  • sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,

    2 hrs

Secondary Outcomes (1)

  • extubation time

    2 hrs

Study Arms (3)

group 1

ACTIVE COMPARATOR

patients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Drug: sugammadex reversal of neuromuscular blockade

group II

ACTIVE COMPARATOR

patients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Drug: sugammadex reversal of neuromuscular blockade

group III

ACTIVE COMPARATOR

patients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)

Drug: sugammadex reversal of neuromuscular blockade

Interventions

sugammadex reversal of neuromuscular blockadeDRUG
group 1group IIgroup III

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • morbidly obese patients of both sex (BMI \> 40 kg.m-2)
  • scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of NMB
  • aged between 18 and 60 years and classified as ASA II - III

You may not qualify if:

  • liver and renal dysfunction,
  • disabling neuropsychiatric disorders,
  • history of stroke, brain trauma in the last 12 months
  • hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure
  • difficult tracheal intubation, and known or suspected disorder affecting NMB.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Instuite

Asyut, 171516, Egypt

Location

Study Officials

  • Ahmed H Othman, MD

    ASSUIT UNVERSITY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 18, 2016

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

EG(1)