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

Tabriz University of Medical Sciences0 个研究点目标入组 1,650 人开始时间: 待定最近更新: 2019年3月25日

适应症

试验速览

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•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

•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

发起方