Clinical trial NCT04973878: The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia.
Official title: The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia Induced by Propofol Combined With Fentanyl: A Prospective Randomized Controlled ,Two Centers Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bidirectional Endoscopy
Deep Sedation
Keywords: Bidirectional Endoscopy
Deep Sedation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Soochow University
First posted: 2021-07-22
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing same-day bidirectional endoscopy under deep sedation will be randomly assigned to either the colonoscopy-first group (colonoscopy followed by EGD, n = 272) or the EGD-first group (EGD followed by colonoscopy, n = 272).
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to explore the optimal sequence of same-day bidirectional endoscopy under deep anesthesia induced by propofol combined with fentanyl.

Detailed description: Same-day bidirectional endoscopy are commonly performed to evaluate iron deficiency anemia, positive fecal occult blood, abdominal pain and cancer screening. In order to reducing intraoperative pain, providing better operating conditions and improving the endoscopic examination quality, endoscopy with anesthesia assistance has gradually become the choice of more patients. However, the optimal sequence of procedures for same-day bidirectional endoscopy has not been established. This is a two-center, single-blind, randomized, controlled trial. Patients undergoing same-day bidirectional endoscopy under deep sedation will be randomly assigned to either the colonoscopy-first group (colonoscopy followed by EGD, n = 272) or the EGD(esophagogastroduodenoscopy)-first group (EGD followed by colonoscopy, n = 272).The detection rate of adenoma（ADR）, the ADR of right-side colon , Boston score of right-side colon, total dose of anesthetics, operation time, recovery time, adverse events and patient satisfaction will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Any patient with a clinical indication for receiving same day bi-directional endoscopies.

Exclusion Criteria:

* Contraindications of colonoscopy: acute peritonitis; intestinal perforation or suspected intestinal perforation; acute anorectal infection or painful lesions; menstruation; pregnancy; cardiopulmonary insufficiency; prior abdominal and pelvic surgery.
* Contraindications for EGD: severe heart disease, severe heart failure; severe lung disease: asthma : severe hypertension; acute perforation of esophagus, stomach and duodenum; acute severe pharynx and larynx disease gastroscopy can not be inserted; acute stage of corrosive esophageal injury; prior upper digestive tract operation.
* Contraindications for oral intestinal laxative: severe gastrointestinal obstruction or stricture; toxic megacolon; severe acute intestinal infection; dysphagia; disturbance of consciousness; allergy to drug ingredients.
* Allergic to emulsions or opioids.
* ASA score ≥ III

Primary outcomes:
measure: Adenoma Detection Rate
timeFrame: 1 year
measure: Adenoma Detection Rate of the right-sided colon
timeFrame: 1 year
measure: The boston bowel preparation scale of the right-sided colon
timeFrame: 1 year
Secondary outcomes:
measure: Sedation use
timeFrame: 1 year
measure: Overall Duration of BDE Examinations
timeFrame: 1 year
measure: Recovery time
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
measure: Overall patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin hospital Shanghai Jiaotong Universtity, school of medicine
name: Duowu Zou, Ph.D,M.D
role: STUDY_CHAIR
References:
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