NCT03130842

Brief Summary

Diagnostic upper GI endoscopy can be uncomfortable and stressful for many patients. Various methods are available for sedation during this procedure. Because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety. Intravenous midazolam is being used by some centers for sedation during endoscopy, but the oral form can also be used with probably same efficacy. Hence, investigators compare the efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral midazolam in reducing anxiety and pain/discomfort related to the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 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

September 17, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

April 3, 2017

Last Update Submit

April 23, 2017

Conditions

Diagnostic Esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (2)

  • Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake

    Procedure related discomfort is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.

    5 minutes after the procedure

  • Change in anxiety

    Procedure related anxiety is assessed by patients on a 11-point numeric rating scales at baseline and then at 30 minutes after the medication.

    At baseline and at 30 minutes after medication

Secondary Outcomes (6)

  • Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.

    5 minutes after the procedure

  • Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.

    5 minutes after the procedure

  • Duration of the procedure

    From endoscope insertion to endoscope removal

  • Hypotension

    At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.

  • Bradycardia

    At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.

  • +1 more secondary outcomes

Study Arms (2)

Sublingual alprazolam

ACTIVE COMPARATOR
Drug: Sublingual alprazolam

Oral midazolam

ACTIVE COMPARATOR
Drug: Oral midazolam

Interventions

Sublingual alprazolamDRUG

Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.

Sublingual alprazolam
Oral midazolamDRUG

Patients receive one dose of intravenous formulation of alprazolam 7.5 mg for oral-administered (in syrup with apple juice) at least 30 minutes before the procedure.

Oral midazolam

Eligibility Criteria

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

You may qualify if:

  • Referring for upper GI endoscopy
  • Age 18 to 65 years
  • First experience of upper GI endoscopy
  • Class I or II of American Anesthesiology Association
  • Willingness to participate

You may not qualify if:

  • Severe psychiatric, neurological, cardio-vascular, or renal disorders
  • History of allergy or intolerance to benzodiazepines or lidocaine
  • History of upper GI surgery
  • Pregnancy or lactation
  • GI anomalia during endoscopy
  • Need for therapeutic procedures during endoscopy
  • Active bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Alzahra Hospital

Isfahan, 81746-73461, Iran

Location

Related Publications (1)

  • Shavakhi A, Soleiman S, Gholamrezaei A, Khodadoostan M, Shavakhi S, Tahery A, Minakari M. Premedication with sublingual or oral alprazolam in adults undergoing diagnostic upper gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):633-9. doi: 10.1055/s-0034-1377305. Epub 2014 Jun 30.

    PMID: 24977401BACKGROUND

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Vahid Sebghatolahi, MD

    Isfahan University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 27, 2017

Study Start

September 17, 2016

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

IR(1)