Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Pethidine (ERCP)
This study is enrolling participants by invitation only.
Sponsor:
Prince of Songkla University
Information provided by (Responsible Party):
Nisa Netinatsunton, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01709422
First received: September 27, 2012
Last updated: October 17, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to compare combination of propofol and midazolam with pethidine versus midazolam and pethidine for ambulatory ERCP
| Condition | Intervention |
|---|---|
|
Anesthesia |
Drug: Sedation with propofol, midazolam and meperidine. Drug: Sedation with midazolam and meperidine. |
| 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 Pethidine Versus Intravenous Midazolam and Pethidine for Ambulatory Endoscopic Retrograde-cholangiopancreatography Cholangiopancreatography |
Resource links provided by NLM:
Further study details as provided by Prince of Songkla University:
Primary Outcome Measures:
- Endoscopist's satisfaction,Patient's satisfaction [ Time Frame: Day 1 of ERCP ] [ Designated as safety issue: No ]The patient co-operation was rated on ( 1 = poor, 2 = fair, 3 = acceptable, 4 = good, 5 = excellent ) by the endoscopist. The patient were asked to grade the pain by using visual analog scale ( 0 = no pain to 10 = unacceptable pain ) and satisfaction to sedation in the procedure ( 1= unacceptable,2 = extremely uncomfortable, 3 = slightly uncomfortable, 4 = no discomfort)
Secondary Outcome Measures:
- The cardiovascular and respiratory adverse events [ Time Frame: Day 1 of ERCP ] [ Designated as safety issue: Yes ]The cardiovascular and respiratory adverse events were defined as (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 ).
| Enrollment: | 140 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | November 2012 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Propofol, midzolam, meperidine
Sedation with propofol, midazolam and meperidine: propofol 20 mg then 5-10 mg, midazolam 1 mg in age <= 70 years 0.5 mg in age >70 years , meperidine 20 mg .
|
Drug: Sedation with propofol, midazolam and meperidine.
propofol 20 mg then 5-10 mg every 30-60 second, midazolam 1 mg in age <= 70 years 0.5 mg in age >70 years , meperidine 20 mg.
Other Name: pethidine
|
|
Active Comparator: Midazolam and pethidine
Sedation with midazolam and meperidine ,initial midazolam dose 2-5 mg followed by repeated dose 0.5-1 mg with meperidine, meperidine dose 25-50 mg followed by repeated dose 5-10 mg. The dose of sedative agents were titrated until patients conscious sedation.
|
Drug: Sedation with midazolam and meperidine.
midazolam 2-5 mg then 0.5-1 mg every 2-3 minute, meperidine 25-50 mg then 5-10 mg every 2-3 minute
Other Name: pethidine
|
Detailed Description:
ERCP is commonly done under sedation with midazolam and pethidine ,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.
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
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 Institue 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 Gastrornterology and Hepatology, Prince of Songkla University |
| ClinicalTrials.gov Identifier: | NCT01709422 History of Changes |
| Other Study ID Numbers: | 1774906506805161 |
| Study First Received: | September 27, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Prince of Songkla University:
|
Propofol Midazolam Pethidine |
Additional relevant MeSH terms:
|
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 May 16, 2013