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

Prince of Songkla University140 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

140

Conditions

Disorders of Gallbladder, Biliary Tract and Pancrease

Interventions

PropofolDRUG

Propofol is the sedative drug used as an additional sedation to one of the study arm.

MidazolamDRUG

Midazolam is one of the two conventional sedative drugs included in both arms.

MeperidineDRUG

Meperidine is one of the two conventional sedative drugs included in both arms.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Outcomes

Primary Outcomes

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.

Time frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours ]

Secondary Outcomes

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.

Time frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours

Data from ClinicalTrials.gov

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