Simultaneous Injection of Propofol and Rocuronium in Inducing General Anesthesia

April 11, 2018 updated by: Jeong-Hwa Seo, Seoul National University Hospital

Efficacy of Neuromuscular Blockade Before Facemask Ventilation in Inducing General Anesthesia

This study is conducted to evaluate the efficacy of simultaneous injection of propofol and rocuronium in inducing general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing elective surgery requiring endotracheal intubation
  • ASA I, II, and III
  • above 20 years

Exclusion Criteria:

  • refuse to enroll
  • patients with risk of aspirating gastric contents
  • patients in whom NMBs are contraindicated
  • patients with predictors of difficult mask ventilation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: simultaneous administration of propofol and rocuronium

In this group, the investigator will administrate propofol (2ml/kg) and rocuronium (0.6mg/kg) simultaneously, and start facemask ventilation after patient loss consciousness to induce general anesthesia.

The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute.
Drug: administration of propofol and rocuronium
compare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally
Experimental: ordinal administration of propofol and rocuronium

In this group, the investigator will administrate propofol (2ml/kg) first, and follow injection of rocuronium (0.6mg/kg) after patient loss consciousness and confirming facemask ventilation.

The investigator will measure the mean tidal volume (TV) applied during facemask ventilation for 1 minute.
Drug: administration of propofol and rocuronium
compare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean tidal volume
Time Frame: from starting facemask ventilation for 1 minute
mean tidal volume of facemask ventilation in 1 minute
from starting facemask ventilation for 1 minute

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 23, 2017

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHSeo_MV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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