NCT02215382

Brief Summary

The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine combination on hemodynamic parameters and intraocular pressure during tracheal extubation. This prospective, randomised study was designed to compare two reversal methods with respect to changes in IOP, heart rate and blood pressure during tracheal extubation period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_4

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

August 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 21, 2015

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

August 7, 2014

Last Update Submit

April 18, 2015

Conditions

Intraocular Pressure Changes During Tracheal Extubation

Keywords

two reversal methodschanges in IOPheart rateblood pressuretracheal extubation

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation

Secondary Outcomes (2)

  • heart rate

    baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation

  • blood pressure

    baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation

Study Arms (2)

sugammadex

ACTIVE COMPARATOR
Drug: sugammadex

neostigmine + atropine

ACTIVE COMPARATOR
Drug: neostigmine+atropine

Interventions

sugammadexDRUG

sugammadex 2 mg/kg

sugammadex
neostigmine+atropineDRUG

neostigmine 0,05 mg/kg + atropine 0,025 mg/kg

neostigmine + atropine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II physical status
  • elective surgery
  • endotracheal intubation under general anesthesia

You may not qualify if:

  • emergency surgery
  • pregnancy
  • laparoscopic surgery
  • prone position
  • BMI \> 30 kg/m2
  • sedative drug use in last month
  • patients with glaucoma.
  • ASA \> II physical status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Altinordu, Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, assistant professor

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 13, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

April 21, 2015

Record last verified: 2014-08

Locations

TU(1)