NCT00937924

Brief Summary

The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

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

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
11.7 years until next milestone

Results Posted

Study results publicly available

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

4.3 years

First QC Date

June 4, 2008

Results QC Date

July 24, 2023

Last Update Submit

February 22, 2024

Conditions

Endoscopic Ultrasound (EUS)Endoscopic Retrograde Cholangiopancreatography (ERCP)

Keywords

EUSERCPSedation LevelAdverse SymptomsRecovery time

Outcome Measures

Primary Outcomes (3)

  • Average Percentage of Sedation Failures

    The percentage of participants who could not complete the procedure due inability to achieve proper sedation level

    From onset of sedation to completion of procedure, approximately 1 hour.

  • Time to Achieve Adequate Level of Sedation to Begin Procedure

    Pre-Endoscopic Procedure (up to 1 hour maximum)

  • Time for Recovery

    Post-Endoscopic Procedure

Secondary Outcomes (1)

  • Adverse Symptoms From Sedative Agents

    Approximately 3 hours.

Study Arms (3)

Meperidine and midazolam group

PLACEBO COMPARATOR

Control. Normal Saline Injections.

Drug: Meperidine, Midazolam

Meperidine and midazolam, plus Diphenhydramine group

EXPERIMENTAL

Diphenhydramine injections given as adjunct sedative.

Drug: Meperidine, MidazolamDrug: Diphenhydramine

Meperidine and midazolam, plus Promethazne group

EXPERIMENTAL

Promethazine given as an adjunct sedative.

Drug: Meperidine, MidazolamDrug: Promethazine

Interventions

Meperidine, MidazolamDRUG
Meperidine and midazolam groupMeperidine and midazolam, plus Diphenhydramine groupMeperidine and midazolam, plus Promethazne group
DiphenhydramineDRUG
Meperidine and midazolam, plus Diphenhydramine group
PromethazineDRUG
Meperidine and midazolam, plus Promethazne group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.

You may not qualify if:

  • History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine.
  • Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent.
  • Patients with conditions that preclude safe conscious sedation will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H.H. Chao Comprehensive Digestive Disease Center

Orange, California, 92868, United States

Location

MeSH Terms

Interventions

MeperidineMidazolamDiphenhydraminePromethazine

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPropylaminesPhenothiazinesSulfur CompoundsHeterocyclic Compounds, 3-Ring

Results Point of Contact

Title
Dr. Kenneth Chang
Organization
University of California, Irvine
kchang@uci.edu
714-456-6187

Study Officials

  • Kenneth Chang, MD

    UC Irvine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2008

First Posted

July 13, 2009

Study Start

February 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 26, 2024

Results First Posted

February 26, 2024

Record last verified: 2024-02

Locations

US(1)