NCT03270696

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

April 12, 2018

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

August 23, 2017

Last Update Submit

April 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • mean tidal volume

    mean tidal volume of facemask ventilation in 1 minute

    from starting facemask ventilation for 1 minute

Study Arms (2)

simultaneous administration of propofol and rocuronium

EXPERIMENTAL

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

ordinal administration of propofol and rocuronium

EXPERIMENTAL

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

Interventions

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

ordinal administration of propofol and rocuroniumsimultaneous administration of propofol and rocuronium

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Min SH, Im H, Kim BR, Yoon S, Bahk JH, Seo JH. Randomized Trial Comparing Early and Late Administration of Rocuronium Before and After Checking Mask Ventilation in Patients With Normal Airways. Anesth Analg. 2019 Aug;129(2):380-386. doi: 10.1213/ANE.0000000000004060.

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • JH Seo

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2017

First Posted

September 1, 2017

Study Start

August 23, 2017

Primary Completion

January 30, 2018

Study Completion

January 30, 2018

Last Updated

April 12, 2018

Record last verified: 2017-09

Locations