Comparison the efficacy of intravenous and sublingual administration of midazolam on sedation in patients candidate for upper GI endoscopy

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190723004

Enrollment

Registered

2019-07-23

Start date

2018-12-31

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dyspepsia dyspepsia

Interventions

2.5 mg IV bolus dose,5 mg sublingual bolus dose

Experimental Drug,Experimental Drug

intravenous midazolam ,sublingual midazolam

Eligibility

Sex/Gender

All

Age

15 Years to 55 Years

Inclusion criteria

Inclusion criteria: Patients aged 15-55 years old, with ASA class1,2 candidates for first diagnosing upper gastrointestinal endoscopy .

Exclusion criteria

Exclusion criteria: Drug and alcohol addiction and tranquillizers and psychotropic drugsØ› Mental illnesses under medical therapyØ› Severe systemic diseases (cardio-pulmonary-liver-kidney) Ø› History of sedative therapy for at least one month Ø› Pregnant and lactating patients

Design outcomes

Primary

Measure	Time frame
ramsy score before and 40 minutes after medication administration obsevational, scoring method (1 to 6) ,pain/ discomfort during endoscopy obsevational , scoring method (1 to 10),satisfaction score 0, 10,20, 40 minutes (during endoscopy) and at discharge obsevational , scoring method (1 to 10)	—

Secondary

Measure	Time frame
side effects 0, 10,20, 40 minutes (during endoscopy) and at discharge monitoring	—

Countries

Iran

Contacts

Public Contactmohsen nasirian

shahid sadoughi university of medical sciences

mohsennasirian63@gmail.com00983538224000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026