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Completed

NCT Number: NCT01709422

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

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

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Key information

Conditions

Disorders of Gallbladder, Biliary Tract and Pancrease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Propofol

Drug

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

Other names: Diprivan

midazolam

Drug

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

Other names: Benzodiazepine

Meperidine

Drug

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

Other names: Pethidine

Primary outcomes

  1. Procedure Related Time

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

    (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.

Secondary outcomes

  1. Cardiovascular Adverse Events.

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

    (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.

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study 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).

Acronym: ERCP

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 18, 2012
Registry last updated
Oct 22, 2013

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.