Disorders of Gallbladder, Biliary Tract and PancreasePhase 4ERCPNCT01709422
Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.
A Phase 4 study testing Propofol, Midazolam and Meperidine in people with Disorders of Gallbladder, Biliary Tract and Pancrease, run by Prince of Songkla University at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorders of Gallbladder, Biliary Tract and Pancrease
- What is being tested?
- Propofol, Midazolam and Meperidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . All outpatients aged more than 18 years who were schedule for ERCP -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
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).
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
Read the 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.
- Keywords
- Propofol, Midazolam, Meperidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Propofol is the sedative drug used as an additional sedation to one of the study arm.
MidazolamDrug
Also called Benzodiazepine
Midazolam is one of the two conventional sedative drugs included in both arms.
MeperidineDrug
Also called Pethidine
Meperidine is one of the two conventional sedative drugs included in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | 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. Receives: Drug: Propofol; Drug: Midazolam; Drug: Meperidine |
| Conventional | Active comparator | 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. Receives: Drug: Midazolam; Drug: Meperidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of procedure, an expected average of 2.0 hours ]
Secondary outcomes (1)
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.
Measured: participants will be followed for the duration of procedure, an expected average of 2.0 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJun 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disorders of Gallbladder, Biliary Tract and PancreaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Netinatsunton, Prince of Songkla University
- Investigators
- Nisa Netinatsunton, MD, Principal investigator, NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind UniversityNisa Netinatsunton, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709422
- Sponsor's protocol ID
- 1774906506805161
- Acronym
- ERCP
- Status last verified
- Sep 2013
- First submitted
- 27 Sep 2012
- Last updated
- 22 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01709422
- Acronym / sponsor ID
- ERCP / 1774906506805161
- Keywords
- Propofol, Midazolam, Meperidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 27 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Propofol, Drug: Midazolam, Drug: Meperidineboth 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. |
| Conventional | Active comparator | Drug: Midazolam, Drug: Meperidineboth 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- . All outpatients aged more than 18 years who were schedule for ERCP -
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: DiprivanPropofol is the sedative drug used as an additional sedation to one of the study arm. | Drug | Propofol |
| MidazolamAlso: BenzodiazepineMidazolam is one of the two conventional sedative drugs included in both arms. | Drug | Conventional, Propofol |
| MeperidineAlso: PethidineMeperidine is one of the two conventional sedative drugs included in both arms. | Drug | Conventional, Propofol |
Primary outcome
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.
1 secondary outcome
Cardiovascular Adverse Events.
Time frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisa Netinatsunton, MD principal investigator
NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University
Nisa Netinatsunton, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Midazolam and Meperidine in people with Disorders of Gallbladder, Biliary Tract and Pancrease, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Related Time (time frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours ]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.