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Completed

NCT Number: NCT03130842

Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

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.

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Key information

Conditions

Diagnostic Esophagogastroduodenoscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Gastroenterology, Alzahra Hospital

Isfahan, 81746-73461, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sublingual alprazolam

Drug

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

oral midazolam

Drug

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.

Primary outcomes

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

    Time frame: 5 minutes after the procedure

    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.

  2. Change in anxiety

    Time frame: At baseline and at 30 minutes after medication

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

Secondary outcomes

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

    Time frame: 5 minutes after the procedure

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

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

    Time frame: 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.

  3. Duration of the procedure

    Time frame: From endoscope insertion to endoscope removal

    Duration of the procedure is defined as time (minute) from endoscope insertion to endoscope removal.

  4. Hypotension

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

    Blood pressure is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Hypotension episode is defined as systolic blood pressure of < 90 mm Hg

  5. Bradycardia

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

    Heart rate is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Bradycardia episode is defined as heart rate of < 60 bpm.

  6. Desaturation

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

    Arterial O2 saturation is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Desaturation episode is defined as as arterial oxygen saturation of < 90%.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Comparing Efficacy of Oral Midazolam and Sublingual Alprazolam in Reducing Anxiety and Pain/Discomfort Related to Diagnostic Upper Gastrointestinal Endoscopy in Adults

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2017
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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