Trial · NCT01709422
Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.
NCT01709422, Phase 4, Completed, Prince of Songkla University; results first posted 2013-08-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine. Trials, record NCT01709422. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01709422
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine.
- NCT number
- NCT01709422
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 140 participants, actual
- Lead sponsor
- Prince of Songkla University
- Conditions
- Disorders of Gallbladder, Biliary Tract and Pancrease
- Interventions
- Propofol, Midazolam, Meperidine
- First posted
- 2012-10-18
- Last updated
- 2013-10-22
- Results first posted
- 2013-08-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Procedure Related Time | 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 | Cardiovascular Adverse Events. | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Cardiovascular Adverse Events. | participants will be followed for the duration of procedure, an expected average of 2.0 hours | Intention to treat population include participants who received sedative agents and underwent ERCP. | Participants | NUMBER |
| PRIMARY | Procedure Related Time | participants will be followed for the duration of procedure, an expected average of 2.0 hours ] | Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP). | minutes | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cardiovascular Adverse Events. | Propofol,Midazolam and Meperidine | Participants with desatuartion | 26 | Participants | |
| Cardiovascular Adverse Events. | Midazolam and Meperidine | Participants with desatuartion | 40 | Participants | |
| Cardiovascular Adverse Events. | Propofol,Midazolam and Meperidine | Participants with hypotension | 12 | Participants | |
| Cardiovascular Adverse Events. | Midazolam and Meperidine | Participants with hypotension | 14 | Participants | |
| Cardiovascular Adverse Events. | Propofol,Midazolam and Meperidine | Participants with bradycardia | 1 | Participants | |
| Cardiovascular Adverse Events. | Midazolam and Meperidine | Participants with bradycardia | 0 | Participants | |
| Procedure Related Time | Propofol,Midazolam and Meperidine | procedure time | 40.67 | Standard Deviation 27.50 | minutes |
| Procedure Related Time | Midazolam and Meperidine | procedure time | 43.24 | Standard Deviation 31.35 | minutes |
| Procedure Related Time | Propofol,Midazolam and Meperidine | induction time | 3.94 | Standard Deviation 2.18 | minutes |
| Procedure Related Time | Midazolam and Meperidine | induction time | 5.47 | Standard Deviation 2.51 | minutes |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Propofol | 70 | |
| Overall Study | STARTED | Conventional | 70 | |
| Overall Study | COMPLETED | Propofol | 70 | |
| Overall Study | COMPLETED | Conventional | 70 | |
| Overall Study | NOT COMPLETED | Propofol | 0 | |
| Overall Study | NOT COMPLETED | Conventional | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | Propofol,Midazolam and Meperidine | 26 | 70 | 26 |
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | Midazolam and Meperidine | 40 | 70 | 40 |
| serious | Severe bradycardia | Cardiac disorders | Propofol,Midazolam and Meperidine | 1 | 70 | 1 |
| serious | Severe bradycardia | Cardiac disorders | Midazolam and Meperidine | 0 | 70 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Propofol,Midazolam and Meperidine | ||
| Total, all-cause mortality | Midazolam and Meperidine | ||
| Total, other adverse events | Propofol,Midazolam and Meperidine | 26 | 70 |
| Total, other adverse events | Midazolam and Meperidine | 40 | 70 |
| Total, serious adverse events | Propofol,Midazolam and Meperidine | 1 | 70 |
| Total, serious adverse events | Midazolam and Meperidine | 0 | 70 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Propofol,Midazolam and Meperidine vs Midazolam and Meperidine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01709422
GET https://conductscience.org/api/trials/v1/NCT01709422/registered