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Evaluation of the Effect of Intradermal Dihydroquin Dos on Providing Sedation for Patients with Digestive Disease

A Prospective, Multicenter, Randomized, Evaluation of the Efficacy of Intranasal Administration of PCDX in Providing Moderate Sedation for Patients Undergoing Gastrointestinal Endoscopic Procedures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160103025821N6
Enrollment
1650
Registered
2019-03-14
Start date
2018-04-19
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Effect of Intradermal Dosage Injection (PCDX). Diseases of the digestive system

Interventions

Intervention 1: Intervention group: Intervention group: First, in all subjects with maximum sterile precautions, it is taken in the intravenous route and then given to a patient randomly. Monitoring o

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Symptoms of diagnostic and endoscopic interventions of upper or lower GI procedures, or both Male and female at least 18 years old Otherwise, the patient is healthy or ill with mild systemic disease, which is well controlled Urinalysis or pregnancy serum in female patients at the start of the study Being able to provide informed consent is signed

Exclusion criteria

Exclusion criteria: Patients under the age of 18 years or those unable to sign an informed consent Surgical procedures or those who have had an open surgical procedure for endoscopic surgery within one week Chronic opioid use or benzodiazepine for anxiety, insomnia and chronic pain Severe hyperactivity (heart rate <45 bpm) Low blood pressure (systolic blood pressure less than 90 mmHg) Advanced heartbeats, AV blocks, second and third grade, and a branch block of the sinusoidal bacillary block that is detected during the monitoring stages in the EKG, which lasts for more than 15 seconds The chronic use of beta blockers, the calcium channel block, which may cause chronic diarrhea and life threatening bradycardia Detection of ECG 12 Lead by QT. The patient will typically not be screened for this variable Patients with upper and lower GI bleeding and patients with unstable hemodynamics Pregnant pregnant women Patients with advanced liver failure Patients who have been treated with any drug in the last 30 days Undesirable reactions to medications or predscheks in previous use History of mental disorder or use of psychiatric drugs Patients with pain in the intestinal tract Gastrectomy history There may be serious illnesses simultaneously

Design outcomes

Primary

MeasureTime frame
Low blood pressure. Timepoint: mmediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: Monitoring, Sphygmomanometer tool.;Nausea. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: Ask the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hojjat Pourfathi

Tabriz University of Medical Sciences

pourfathih@tbzmed.ac.ir+98 914 313 8969

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026