Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-03

Study Completion Date

2020-01-30

Brief Summary

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The purpose of this research is to compare the effect of different procedural sequences on the time to recovery and the propofol sedation requirements in patients undergoing bidirectional endoscopy with sedation.

The two sequences are:

* Colonoscopy followed by Esophagogastroduodenoscopy (EGD)
* EGD followed by Colonoscopy

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Detailed Description

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120 patients will be asked to participate in the trial. The subject will undergo both procedures in the order assigned by the randomization sheet. During the procedure, the endoscopist and anesthesiologists will collect data including but not limited to vital signs (heart rate, blood oxygen level, blood pressure) and level of sedation through the Bispectral Index Monitor (BIS). After completing the procedures, the patient will be approached in the recovery room by the study coordinator who will administer the Modified Post Anesthesia Discharge Scoring System (M-PADSS) scale every 5 minutes until a score of 9 or higher is obtained on two consecutive attempts. 24 hours following the procedure, the study coordinator will call the patient in order to assess the patient's cognitive function and drowsiness after they were discharged from the endoscopy unit.

Conditions

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Anesthesia, Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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EGD followed by Colonoscopy

Randomized to group Esophagogastroduodenoscopy followed by Colonoscopy

Group Type ACTIVE_COMPARATOR

EGD followed by Colonoscopy

Intervention Type OTHER

Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy

Colonoscopy followed by EGD

Randomized to group Colonoscopy followed by Esophagogastroduodenoscopy

Group Type ACTIVE_COMPARATOR

Colonoscopy followed by EGD

Intervention Type OTHER

Colonoscopy is done first followed by EGD

Interventions

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Colonoscopy followed by EGD

Colonoscopy is done first followed by EGD

Intervention Type OTHER

EGD followed by Colonoscopy

Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age above 18
* Scheduled EGD and colonoscopy on the same day
* Scheduled to Anaesthesiologist administered sedation during the procedure

Exclusion Criteria

* Age below 18
* Known allergy or adverse reaction to Propofol, Midazolam or opioid medication (ex: fentanyl)
* Medical contraindication to Anaesthesia
* Sleep apnea
* American Society of Anesthesiologists classification (ASA) \>3
* Inpatient status
* Pregnant or lactating women
* Known cirrhosis
* Chronic Kidney Disease (stage 4 or 5)
* Known psychological disorder
* Known cognitive dysfunction
* Significant gastroparesis
* Gastric outlet obstruction
* Ileus
* Known or suspected bowel obstruction or perforation
* Having a stoma
* Compromised swallowing reflex or mental status
* Prior colon resection or gastric surgery
* Age above 75 years
* Chronic use of more than 1 psychoactive drug (Benzodiazepines, Tricyclic antidepressants, antipsychotics, selective serotonin receptor inhibitors, serotonin norepinephrine receptor inhibitors, Monoamine oxidase inhibitor)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes