Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.

Disorders of Gallbladder, Biliary Tract and Pancrease Clinical Trial

— ERCP  

Official title:

Efficacy and Safety Profiles of Sedation With Propofol Combined With Intravenous Midazolam and Meperidine Versus Intravenous Midazolam and Meperidine for Ambulatory Endoscopic Retrograde-cholangiopancreatography(ERCP).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709422
• Other study ID #: 1774906506805161
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2012
• Last updated: September 12, 2013
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: September 2013
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare efficacy and safety of combination of propofol and midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP

Description:

ERCP is commonly done under sedation with midazolam and meperidine, however some studies showed varying outcomes of this conventional sedation for maintained sedation. Propofol is increasing used for sedation in gastrointestinal procedure owing to its rapid recovery profiles but the complications associated with propofol are not negligible.The investigators prospectively compare the efficacy, induction time, recovery time, patient satisfaction and side effect between propofol based and conventional sedations in patients undergoing ERCP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

. All outpatients aged more than 18 years who were schedule for ERCP -

Exclusion Criteria:

• pregnant woman

• emergency situation ( i.e. concomitant upper gastrointestinal bleeding, acute cholangitis )

• American Society of Anesthesiologist ( ASA )Class IV or V

• respiratory disease,

• sleep apnea

• allergy to egg or soybean

• drug abuse( benzodiazepine, opioid agonist )

• previous history of failure sedation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disorders of Gallbladder, Biliary Tract and Pancrease
• Gallbladder Diseases

Intervention

Drug:
• Propofol
Propofol is the sedative drug used as an additional sedation to one of the study arm.
• Midazolam
Midazolam is one of the two conventional sedative drugs included in both arms.
• Meperidine
Meperidine is one of the two conventional sedative drugs included in both arms.

Locations

Country	Name	City	State
Thailand	NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Related Time	(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.	participants will be followed for the duration of procedure, an expected average of 2.0 hours ]	No
Secondary	Cardiovascular Adverse Events.	(1) desaturation(oxygen saturation < 90 % at least 10 second ) (2) hypotension ( systolic blood pressure < 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate < 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation < 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.	participants will be followed for the duration of procedure, an expected average of 2.0 hours	Yes

External Links

•   Prince of Songkhla University