NCT02364934

Brief Summary

To explore and compare the effects of propoful, sevoflurane, and a combination of both on the pharmacokinetics and pharmacodynamics of rocuronium. To discover and confirm sex differences on the pharmacokinetics and pharmacodynamics of rocuronium. To evaluate and examine aged people on the pharmacokinetics and pharmacodynamics of rocuronium.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

December 23, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

December 23, 2014

Last Update Submit

February 24, 2015

Conditions

TOFSex

Keywords

rocuroniumsexelderlyClose-loop infusion system

Outcome Measures

Primary Outcomes (1)

  • Time to give additional rocuromium

    A personal computer, working in a closed-loop system with the Relaxograph and a syringe infusion pump was used to administer rocuronium at the rate necessary for a stable 90-99% block of the first twitch response (1%\<T1\<10%).

    24h

Secondary Outcomes (4)

  • Total dose of rocuronium

    24h

  • Bispectral index（BIS）

    24h

  • Time to spontaneous breathing recovery, eye opening, extubation

    24h

  • Agitation score

    24h

Study Arms (8)

Propofol

Propofol is intravenously administrated during anesthesia maintenance in patients (18-65 years old)

Drug: Propofol

Sevoflurane

Sevoflurane (inhalation) is administrated during anesthesia maintenance in patients (18-65 years old)

Drug: Sevoflurane

Propofol (elderly)

Propofol is intravenously administrated during anesthesia maintenance in patients (≥65 years old)

Drug: Propofol

Sevoflurane (elderly)

Sevoflurane (inhalation) is administrated during anesthesia maintenance in patients (≥65 years old)

Drug: Sevoflurane

Propofol (men)

Propofol is intravenously administrated during anesthesia maintenance in men (18-65 years old)

Drug: Propofol

Sevoflurane (men)

Sevoflurane (inhalation) is administrated during anesthesia maintenance in men (18-65 years old)

Drug: Sevoflurane

Propofol (women)

Propofol is intravenously administrated during anesthesia maintenance in women (18-65 years old)

Drug: Propofol

Sevoflurane (women)

Sevoflurane (inhalation) is administrated during anesthesia maintenance in women (18-65 years old)

Drug: Sevoflurane

Interventions

PropofolDRUG

This study was designed to determine the dose requirements for rocuronium, administered by continuous infusion to maintain a stable 90-99% T1 depression (depression of the first twitch in the train-of-four, TOF) in adult, elderly and different sex patients under sufentanil and propoful anaesthesia.

PropofolPropofol (elderly)Propofol (men)Propofol (women)
SevofluraneDRUG

This study was designed to determine the dose requirements for rocuronium, administered by continuous infusion to maintain a stable 90-99% T1 depression (depression of the first twitch in the train-of-four, TOF) in adult, elderly and different sex patients under sufentanil and sevoflurane anaesthesia.

SevofluraneSevoflurane (elderly)Sevoflurane (men)Sevoflurane (women)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ASA physical status group I and II undergoing elective surgical procedures were studied. Pateients with neuromuscular and metabolic diseases, morbid obesity or receiving medication known to influence neuromuscular transmission were excluded from the study.

You may qualify if:

  • ASA physical status group I and II
  • elective surgical procedures
  • The subject has given written informed consent to participate

You may not qualify if:

  • Coronary heart disease, bronchial asthma, cardiac, lung, hepatic and renal insufficiency
  • Severe HBP, obesity (BMI\>30)
  • Neuromuscular and metabolic diseases
  • Receiving medication known to influence neuromuscular transmission
  • Pregnancy, psychiatric disease
  • Allergy history
  • Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coitus

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief

Study Record Dates

First Submitted

December 23, 2014

First Posted

February 18, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

February 26, 2015

Record last verified: 2015-02