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- Klinische proef NCT01976845
Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Propofol or Midazolam Versus Placebo for Preoperative Medication in Patients Undergoing Elective Orthopedic Surgery
The purpose of this research is:
To evaluate the sedative (reduces irritability or agitation), anxiolytic (reduces anxiety), and amnesic (produces temporary lack of recall) effects of propofol or midazolam when administered for preoperative medication (before administration of drugs that will put patient to sleep) in comparison to placebo. This study is to test whether the use of the pre-anesthesia medication measurably reduces anxiety in comparison to receiving no pre-anesthesia medication prior to orthopedic procedures.
To assess the effect of propofol in comparison to placebo and midazolam on the ability to recall (memory of):
- when the doctor places the mask on patient's face prior to going to sleep
- recall of 2 pictures
- on your satisfaction with the anesthesia as well as postoperative side effects in post-anesthesia care unit (PACU) e.g., nausea ,vomiting and sedation.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The role of anxiolytic premedication in the ambulatory surgical population is frequently debated. Anesthesiologists may consider the administration of anxiety-reducing drugs unnecessary when anxiety levels are low in outpatients presenting for minor surgery. However, the previous study reports that up to 80% of outpatients expressed a preference for a combination of anxiety-reducing and hypnotic premedication before surgery (1-4). In addition to anxiolysis, goals of anxiolytic premedication include sedation, amnesia, improved patient cooperation, and/or improved patient satisfaction. Intravenous (IV) midazolam is the most commonly used premedicant in the ambulatory setting due to its rapid onset, and short half-life (2,3,5), but its residual effects in the immediate postoperative period may contribute to postoperative sedation, as well as to delayed recovery and discharge-readiness after brief outpatient surgery. Furthermore, White et al. (6) noted that the slope of the dose-response curve for sedation was much steeper with midazolam compared with diazepam, which suggests that midazolam may possess a smaller margin of safety and greater need for careful titration to achieve the desired clinical end-point without untoward side effects.
Propofol has become the IV (intravenous) anesthetic of choice for ambulatory anesthesia because of its excellent recovery profile (7). Clinical experience with propofol in the ambulatory setting suggests that its use is associated with less residual sedation and lower incidence of postoperative nausea and vomiting (PONV) (8). However, there are some undesirable side effects associated with propofol including pain on injection, cardiovascular and respiratory depression, and occasional excitement on emergence from anesthesia (9). Practically, small doses of propofol (10-20 mg IV) have been used as an anxiolytic/sedative medication.
To date, there is only one study that has evaluated propofol versus midazolam versus placebo as premedication (10). In this study, the authors stated that propofol (0.4 mg/kg IV) had anxiolytic effects comparable in magnitude and duration to midazolam (0.04 mg/kg IV) with less memory impairment, respiratory depression and dizziness. However, they did not assess the efficacy of propofol and midazolam as a premedication on the recovery profiles and patient's satisfaction in their study. Compared to placebo and propofol, midazolam was associated with more frequent respiratory depression and significant impairment of anterograde explicit memory. Both propofol and midazolam helped relieve anxiety and lowered blood pressure (compared to baseline) but both were associated with greater dizziness scores (P<0.001, compared to placebo).
They concluded that Propofol had an anxiolytic effect comparable in magnitude and duration to that of midazolam with less memory impairment, respiratory depression and dizziness.
Propofol appears to be an economical, effective and safe alternative to midazolam for treating pre-anesthesia anxiety, and especially to be used for induction of anesthesia (10). (This sentence is not clear).
Therefore, we designed this randomized, double-blind, and placebo-controlled study to evaluate propofol as a premedication and to see if it:
- produces comparable anxiolytic effects to midazolam when compared to placebo, but with less memory impairment
- facilitates early recovery profile
- improves patient's satisfaction with the induction and early recovery from anesthesia.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90048
- Cedars Sinai Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Willingness and ability to sign an informed consent document
- No allergies to midazolam or propofol
- 18 - 70 years of age
- American Society of Anesthesiologists (ASA) Class I-III adults of either sex
Exclusion Criteria:
- Patients with known allergy, hypersensitivity or contraindications to midazolam, propofol, anesthetic or analgesic medications
- Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases
- Pregnant or lactating women
- Subjects with a history of alcohol or drug abuse within the past 3 months
- Patients chronically using sedative, anxiolytic drugs prior to the surgery
- Morbid obesity (BMI >40 kg/m2)
- Patients who are agitated or confused prior to receiving the drug ( verbal rating scale [VRS] greater then 6)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Propofol
Propofol 20 mg IV (2 ml)
|
Propofol (20mg) 2 ml IV, in the pre-op area as a premedication
Andere namen:
|
Actieve vergelijker: Midazolam
Midazolam 2 mg IV (2 ml)
|
Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication
Andere namen:
|
Placebo-vergelijker: Saline
Saline 2 ml
|
Saline 2 ml IV, in the pre-op area as a premedication
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Scores on the Verbal Rating Scale For Anxiety
Tijdsspanne: one day
|
Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely nervous)
|
one day
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Scores on the Verbal Rating Scale For Sleepiness (Sedation)
Tijdsspanne: one day
|
Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely sleepiness)
|
one day
|
Produces Amnesia(Memory Recall)
Tijdsspanne: one day
|
Ability to recall (memory of): •recall of 2 pictures |
one day
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Depressiva van het centrale zenuwstelsel
- Anesthesie, intraveneus
- Anesthesie, generaal
- Anesthesie
- Rustgevende agenten
- Psychotrope medicijnen
- Hypnotica en sedativa
- Adjuvantia, anesthesie
- Middelen tegen angst
- GABA-modulatoren
- GABA-agenten
- Midazolam
- Propofol
Andere studie-ID-nummers
- Pro00025204
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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Poitiers University HospitalVoltooid
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Boston Scientific CorporationBeëindigdPijn | Rugpijn | Failed Back Surgery SyndroomVerenigde Staten, Verenigd Koninkrijk, Canada, Frankrijk
Klinische onderzoeken op Propofol
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Hopital FochVoltooid
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Konkuk University Medical CenterVoltooidCoronaire hartziekte | Valvulaire hartziekteKorea, republiek van
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University Medical Center GroningenVoltooidAnesthesie | Hemodynamische instabiliteit | Interactie | Stoornis van zuurstoftransportNederland
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B. Braun Melsungen AGVoltooid
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Asan Medical CenterVoltooidGezondKorea, republiek van
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Tiva GroupMedtronic - MITGVoltooid
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Huazhong University of Science and TechnologyVoltooidLaparoscopische chirurgie | Hysteroscopische chirurgieChina
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Mansoura UniversityVoltooid
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KVG Medical College and HospitalOnbekend
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Acibadem UniversityVoltooidOphalen van eicellenKalkoen