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Completed

NCT Number: NCT02174588

Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial

Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.

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Key information

Conditions

EGD Procedure

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei university College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • over 19 years old, male and female
  • patients who have plan to get esophagogastroduodenoscopy (EGD)

Exclusion criteria

  • ASA class III or IV
  • Allergies to propofol, sulfites or eggs
  • patients who had surgery for esophagus, stomach or duodenum
  • inpatients
  • patients who had sleep apnea, gastroparesis or achalasia
  • patients who are taking sedative drugs more than 6 months
  • pregnancy
  • hypotension (systolic pressure less than 90mmHg), bradycardia (pulse rates less than 50 times per minute) or hypoxia (SpO2 less than 90%)
  • psychiatric or neurologic problems (ex. epilepsy or dementia)

Treatment and study plan

Midazolam + propofol

Drug

Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.

Propofol

Drug

propofol are used for sedation drug

Primary outcomes

  1. visual analog scale

    Time frame: Within the 24 hours after EGD

    The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone

Secondary outcomes

  1. complications rates

    Time frame: Within the 1 hour after EGD

    The recovery time after EGD following balanced propofol sedation versus propofol sedation alone. The safety after EGD following balanced propofol sedation versus propofol sedation alone

Other outcomes

  1. complications rates

    Time frame: Within the 1 hour after EGD

    The safety after EGD following balanced propofol sedation versus propofol sedation alone

  2. total dose of the sedation drugs

    Time frame: Within the 1 hour after EGD

    The economy after EGD following balanced propofol sedation versus propofol sedation alone

  3. visual analog scale

    Time frame: Within the 1 hour after EGD

    The endoscopist's satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2014
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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