Clinical Trials Logo

Clinical Trial Summary

Nonanesthesiologist administration of propofol for sedation is actually a field of growing interest for endoscopists, as demonstrated by recent American and European guidelines on this issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a single agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation (BPS), which combines propofol with small doses of a benzodiazepine and/or an opioid, can be successfully titrated to moderate sedation. However, nonanesthesiologists propofol administration remains controversial on account of the possibility of deep sedation/general anesthesia related adverse events. On the other hand, the use of longer elimination half-life drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and recovery.

Up to date, no study has addressed a head-to-head comparison of both regimens administered by non-anesthesiologists and titrated to moderate sedation.

This study aims to evaluate the impact on propofol sedation of premedication with a fixed dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate sedation, in terms of depth of sedation, recovery times, safety and satisfaction.

The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts a minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam may increase the depth of sedation through the initial phases of the procedure, diminishing propofol requirements, but not prolonging significantly recovery times.


Clinical Trial Description

Justification of the study:

Nonanesthesiologist administration of propofol is controversial owing to deep sedation concerns. One of the latest therapeutic innovations on this issue has been the development of balanced propofol sedation, which consists of adding low doses of opioids or benzodiazepins. Several studies have recently demonstrated that BPS allows successfully moderate sedation, maintains a reversible drug component, reduces the total dose of propofol even by more than 50% without increasing adverse events and maintains high levels of physician and patient satisfaction, even for advanced endoscopic procedure. However, recovery may be prolonged by using midazolam or meperidine as they have a longer elimination half-life than propofol has.

Up to date, nonanesthesiologist administration of propofol and BPS, using either midazolam or fentanyl, for outpatient colonoscopy have been compared in a single non-placebo controlled randomized trial (VanNatta and Rex, 2006). In this study, the authors obtained shorter recovery times with BPS compared to propofol alone, in contrast with the expected on account of pharmacokinetics. These results can be easily understood yet single-agent propofol was titrated to deep sedation, whereas BPS was titrated to moderate sedation.

Therefore, it is necessary to make a randomized, double-blinded, placebo-controlled trial to directly compare both sedation regimens targeted to a similar moderate level of sedation. The results of this study will conclude which should be the first line treatment for moderate sedation in colonoscopy, providing further insight in drug synergy and its impact on the depth of sedation and recovery times ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01428882
Study type Interventional
Source Infante, Javier Molina, M.D.
Contact
Status Completed
Phase Phase 4
Start date June 2011
Completion date December 2011

See also
  Status Clinical Trial Phase
Completed NCT01425502 - Data-driven Quality Improvement in Primary Care - Trial N/A
Recruiting NCT01756183 - Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer Phase 2
Completed NCT01355016 - A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers Phase 1
Completed NCT01757860 - Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects Phase 1
Completed NCT01179854 - Remegal Different Doses in Patients With Refractory Partial Seizures Phase 2
Completed NCT00376415 - A Safety Study of Lessertia Frutescens in Adults. Phase 1
Active, not recruiting NCT01722916 - Reducing and Removing Hyaluronic Acid Filler With Hyaluronidase Early Phase 1
Completed NCT01727778 - Safety and Preliminary Efficacy Study of the Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT01475097 - Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography Phase 4
Completed NCT01412658 - Clinical Safety of a Novel Milk Protein Peptide Phase 1
Terminated NCT01847222 - An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATEā„¢ in Healthy Volunteers. Phase 1
Unknown status NCT01633099 - Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients Phase 3
Recruiting NCT01297842 - Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections Phase 4
Completed NCT01284582 - Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP) Phase 1
Completed NCT01557270 - Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery Phase 3
Completed NCT01556607 - A Trial to Assess the Safety, Tolerability and Pharmacokinetics of MDT-637 in Subjects With Intermittent, or Mild-to-Moderate Persistent, Asthma Phase 1
Completed NCT01319903 - Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29 Phase 1
Completed NCT01271569 - A Study to Assess the Efficacy and Safety of Fospropofol Disodium Phase 1
Recruiting NCT04785027 - Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis Phase 1/Phase 2
Completed NCT01367873 - Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects Phase 1