Clinical trial NCT02027311: Etomidate vs. Midazolam for Sedation During ERCP
Official title: Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Choledocholithiasis
Cholangiocarcinoma
Pancreatitis
Pancreatic Cancer
Keywords: Endoscopic Retrograde Cholangiopancreatography (ERCP)
Conscious Sedation
etomidate
midazolam
Lead sponsor: Cheju Halla General Hospital
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

  1. tachypnea, respiration rate more than 25/min or less than 10/min
  2. Oxygen saturation : 90% or less
  3. Systolic blood pressure : less than 90 mmHg or more than 180 mmHg
  4. Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg
  5. Heart rate : more than 120 beat/min or less than 50 beat/min.

Primary outcomes:
measure: Number of Intervention
timeFrame: Throughout the whole ERCP procedure
Secondary outcomes:
measure: Event of Hypoxia
timeFrame: Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase
Other outcomes:
Locations:
city: Jeju-si
country: Korea, Republic of
facility: 1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital
state: Jeju Special Self-Governing Province
Study officials:
affiliation: Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766
name: BYUNG HYO CHA, Dr.
role: STUDY_CHAIR
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