NCT03003884

Brief Summary

The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 8, 2017

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

December 22, 2016

Last Update Submit

September 6, 2017

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

  • successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.

    From start of study drug injection to patient discharge (approx. 3 hours)

Secondary Outcomes (5)

  • recovery time as measured by time

    After the last of study drug injection to patient discharge (approx. 3 hours)

  • rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy

    From start of study drug injection to patient discharge (approx. 3 hours)

  • rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy

    From start of study drug injection to patient discharge (approx. 3 hours)

  • rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy

    From start of study drug injection to patient discharge (approx. 3 hours)

  • pain on injection was assessed by the patient immediately after administration of the study drug

    1-10 minutes (from the beginning of sedation )]

Study Arms (5)

Remimazolam Tosilate 1

EXPERIMENTAL

IV of Remimazolam Tosilate at 5mg for initial dose

Drug: Remimazolam Tosilate

Remimazolam Tosilate 2

EXPERIMENTAL

IV of Remimazolam Tosilate at 7mg for initial dose

Drug: Remimazolam Tosilate

Remimazolam Tosilate 3

EXPERIMENTAL

IV of Remimazolam Tosilate at 8mg for initial dose

Drug: Remimazolam Tosilate

Remimazolam Tosilate 4

EXPERIMENTAL

IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected.

Drug: Remimazolam Tosilate

Propofol

ACTIVE COMPARATOR

IV of Propofol at 1.5mg/kg for initial dose

Drug: Propofol

Interventions

Remimazolam TosilateDRUG

Initial dose plus supplemental doses as necessary.

Remimazolam Tosilate 1Remimazolam Tosilate 2Remimazolam Tosilate 3Remimazolam Tosilate 4
PropofolDRUG

Initial dose plus supplemental doses as necessary.

Propofol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • subjects aged 18-60 years；
  • intending to undergo diagnostic upper GI endoscopy
  • American Society of Anesthesiologists Physical Status Score (ASA PS) I or II；
  • kg/m²\<BMI(Body Mass Index)\<30 kg/m².

You may not qualify if:

  • Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator;
  • one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
  • history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
  • history of severe cardiovascular disease;
  • cerebral disease or mental disorder;
  • allergic to drugs used in the study;
  • pregnant women or those in lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 28, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

September 8, 2017

Record last verified: 2016-12

Locations

CN(1)