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Propofol vs. Midazolam-based Balanced Propofol for Nonanesthesiologist Moderate Sedation in Colonoscopy (MIDAPROP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Javier Molina-Infante, MD, Infante, Javier Molina, M.D.
ClinicalTrials.gov Identifier:
NCT01428882
First received: September 2, 2011
Last updated: April 16, 2016
Last verified: April 2016
Results First Received: March 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Procedural Sedation
Interventions: Drug: Midazolam
Drug: Propofol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Midazolam Balanced Propofol Sedation

2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion

Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level

Single-agent Propofol Sedation

2 ml saline followed by continuous propofol iv infusion

Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level


Participant Flow:   Overall Study
    Midazolam Balanced Propofol Sedation     Single-agent Propofol Sedation  
STARTED     67     68  
COMPLETED     61     58  
NOT COMPLETED     6     10  
Lack of Efficacy                 2                 7  
Protocol Violation                 4                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients were similar at baseline without differences regarding age, gender, body mass index, ASA class or indication for colonoscopy.

Reporting Groups
  Description
Midazolam Balanced Propofol Sedation

2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion

Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level

Single-agent Propofol Sedation

2 ml saline followed by continuous propofol iv infusion

Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level

Total Total of all reporting groups

Baseline Measures
    Midazolam Balanced Propofol Sedation     Single-agent Propofol Sedation     Total  
Number of Participants  
[units: participants]
  61     58     119  
Age  
[units: years]
Mean (Full Range)
  58  
  (19 to 80)  
  55  
  (20 to 86)  
  56  
  (19 to 86)  
Gender  
[units: participants]
     
Female     34     30     64  
Male     27     28     55  
Body Mass Index  
[units: Kg/m2]
Mean (Standard Deviation)
  25.8  (4.6)     25.1  (3.5)     25.4  (4.1)  
Educational degree  
[units: participants]
     
No degree     14     14     28  
High school     5     11     16  
Technical     20     10     30  
College     11     10     21  
Graduate degree     11     13     24  
ASA class [1]
[units: participants]
     
ASA 1     22     31     53  
ASA 2     32     19     51  
ASA 3     7     8     15  
[1] ASA 1: a normal healthy patient (e.g., Healthy, non-smoking, no or minimal alcohol use) ASA 2: a patient with mild systemic disease (e.g., current smoker, social alcohol drinker, pregnancy, obesity, well-controlled diabetes mellitus or arterial hypertension) ASA 3: Substantive functional limitations in a patient with one or more moderate to severe diseases (e.g., poorly controlled diabetes mellitus or arterial hypertension, chronic obstructive pulmonary disease, morbid obesity, implanted pacemaker, moderate reduction of ejection fraction, patients on scheduled dialysis)



  Outcome Measures
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1.  Primary:   Level of Sedation Throughout the Entire Procedure   [ Time Frame: Up to 1 hour after introduction of the colonoscope ]

2.  Secondary:   Duration of Recovery After the Endoscopic Procedure   [ Time Frame: Up to 1 hour after colonoscopy ]

3.  Secondary:   Rate of Sedation-related Complications During the Procedure and the Recovery Phases   [ Time Frame: Up to two hours, including colonoscopy performance and recovery period ]

4.  Secondary:   Rate of Patients and Physician Satisfaction With Sedation   [ Time Frame: Up to 1 hour after colonoscopy for endoscopists and up to 48 hours for patients ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Single center study. Small sample size. Fixed and relatively high-dose midazolam (2 mg). Lack of distinction between complications related to either pain stimuli or oversedation.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Javier Molina-Infante
Organization: Hospital San Pedro de Alcantara, Caceres
phone: 0034927621543
e-mail: xavi_molina@hotmail.com


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Javier Molina-Infante, MD, Infante, Javier Molina, M.D.
ClinicalTrials.gov Identifier: NCT01428882     History of Changes
Other Study ID Numbers: MIDP11
Study First Received: September 2, 2011
Results First Received: March 17, 2016
Last Updated: April 16, 2016
Health Authority: Spain: Spanish Agency of Medicines