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Completed

NCT Number: NCT02027311

Etomidate vs. Midazolam for Sedation During ERCP

Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

The investigators are now trying to investigate that etomidate with meperidine combination regimen is superior to the midazolam with meperidine more effective and less harm on sedation during the ERCP procedure.

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Key information

Conditions

Choledocholithiasis Adenocarcinoma Bile Duct Diseases Biliary Tract Diseases Carcinoma Cholangiocarcinoma Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pancreatitis

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital

Jeju City, Jeju Special Self-Governing Province, 690-766, South Korea

About this study

ERCP (Endoscopic retrograde cholangiopancreatogram) is an uncomfortable and time-consuming procedure compared to other endoscopic procedures. Most ERCP procedure had been performed in sedation using tranquilizers and pain-killers.

Until recently, midazolam and opioid combination regimen recognized as a standard therapy is widely used, but the sedative effect is insufficient and intermittent paradoxical reaction has been questioned. Another drug, such as propofol, has been known that the sedative effect is superior one of the midazolam but disappointed due to narrow therapeutic range of respiratory distress and absence of antagonist. Meanwhile, recently up-coming drug, etomidate which is a modulator of GABA-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

For these advantages, this short acting sedative drug has been widely used in the emergency room during minor operation and in the operation room for induction. However, research on the efficacy during ERCP was not yet published.

In this regards, the purpose of the investigators study is to prove the efficacy of etomidate for sedation and to establish new evidence based sedation guidelines during ERCP procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients who are scheduled diagnositic or therapeutic ERCP.
  • Age : more than 20 and less than 90 years old
  • ASA(American Society of Anesthesiologists) classificiation : I, II, III

Exclusion criteria

Patients following

  • Refuse to be enrolled
  • ASA American Society of Anesthesiologists)classification IV, V
  • Breast feeder
  • The mentally ill
  • Drug abuser
  • Hypersensitivity to sedative or opioids
  • Alcohol intoxication or dependency
  • Body mass index (BMI) 36kg/m2 or more
  • Unstable vital sign
  • tachypnea, respiration rate more than 25/min or less than 10/min
  • Oxygen saturation : 90% or less
  • Systolic blood pressure : less than 90 mmHg or more than 180 mmHg
  • Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg
  • Heart rate : more than 120 beat/min or less than 50 beat/min.

Treatment and study plan

Etomidate

Drug

This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.

Other names: Etomidate lipro IV

midazolam

Drug

This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.

Meperidine

Drug

Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.

Other names: Pethidine

Primary outcomes

  1. Number of Intervention

    Time frame: Throughout the whole ERCP procedure

    The frequency of intervention which was defined as any restraint of the patient's head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.

Secondary outcomes

  1. Event of Hypoxia

    Time frame: Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase

    Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%

Sponsors and collaborators

Lead sponsor

Cheju Halla General Hospital

Other

Registry information

Official study title

Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2014
Registry last updated
Jun 29, 2015

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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