Intraocular Pressure Changes Associated With Tracheal Extubation: Comparison of Sugammadex With Conventional Reversal of Neuromuscular Blockade

April 18, 2015 updated by: özgür yağan, T.C. ORDU ÜNİVERSİTESİ

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ordu
      • Altınordu, Ordu, Turkey, 52100
        • Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sugammadex
Drug: sugammadex
sugammadex 2 mg/kg
Active Comparator: neostigmine + atropine
Drug: neostigmine+atropine
neostigmine 0,05 mg/kg + atropine 0,025 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intraocular pressure
Time Frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
heart rate
Time Frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
blood pressure
Time Frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 18, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Odu-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intraocular Pressure Changes During Tracheal Extubation

Clinical Trials on sugammadex

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe