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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nisa Netinatsunton, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01709422
First received: September 27, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Disorders of Gallbladder, Biliary Tract and Pancrease
Drug: Propofol
Drug: Midazolam
Drug: Meperidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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).

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Procedure Related Time [ Time Frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours ] ] [ Designated as safety issue: No ]
    (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 Outcome Measures:
  • Cardiovascular Adverse Events. [ Time Frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours ] [ Designated as safety issue: Yes ]
    (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.


Enrollment: 140
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol
both midazolam (1mg if aged <= 70 years or 0.5mg in age >70 years) and meperidine 20 mg were given intravenously at the initiation of sedation, Thereafter, an initial bolus of propofol 20 mg intravenously. Sedation was maintained with repeated dose of 5 to 10 mg propofol.
Drug: Propofol
Propofol is the sedative drug used as an additional sedation to one of the study arm.
Other Name: Diprivan
Drug: Midazolam
Midazolam is one of the two conventional sedative drugs included in both arms.
Other Name: Benzodiazepine
Drug: Meperidine
Meperidine is one of the two conventional sedative drugs included in both arms.
Other Name: Pethidine
Active Comparator: Conventional
both midazolam 2 to 5 mg and meperidine 25 to 50 mg were given intravenously at the initiation of sedation. Sedation was maintained with repeated doses of 0.5 to 1.0 mg midazolam and 5 to 10 mg meperidine.
Drug: Midazolam
Midazolam is one of the two conventional sedative drugs included in both arms.
Other Name: Benzodiazepine
Drug: Meperidine
Meperidine is one of the two conventional sedative drugs included in both arms.
Other Name: Pethidine

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709422

Locations
Thailand
NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Nisa Netinatsunton, MD NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University
Principal Investigator: Nisa Netinatsunton, MD Prince of Songkla University
  More Information

Additional Information:
No publications provided

Responsible Party: Nisa Netinatsunton, NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01709422     History of Changes
Other Study ID Numbers: 1774906506805161
Study First Received: September 27, 2012
Results First Received: November 30, 2012
Last Updated: September 12, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
Propofol
Midazolam
Meperidine

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Meperidine
Midazolam
Propofol
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014