- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01315158
Propofol vs Propofol + Benzo/Opiates in High Risk Group
Incidence of Sedation Related Complications With Propofol Alone Versus Propofol With Benzodiazepines and Opiates in a High Risk Group Undergoing Advanced Endoscopic Procedures: A Randomized Controlled Trial
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
The use of propofol (2,6-di-isopropofol) for sedation during endoscopic procedures has increased in recent years primarily because of its favorable pharmacokinetic profile compared with traditional endoscopic sedation with benzodiazepines and opioids. Propofol has a rapid onset of action (30-45 sec) and short duration of effect (4-8 min). There also are data to support the safe use of propofol for advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS).
There is limited information on the incidence of sedation related complications during advanced endoscopy. Prior studies were limited by controlled patient populations at low risk of developing sedation related cardiopulmonary complications. In a recent study, we defined the frequency of sedation related adverse events including the rate of airway modifications (AMs) with propofol use during advanced endoscopy. From a total of 799 patients, AMs were required in 14.4% of patients, hypoxemia in 12.8%, hypotension in 0.5% and premature termination in 0.6% of the patients. In addition, body mass index (BMI), male sex and American Society of Anesthesiologists (ASA) class of 3 or higher were independent predictors of AMs. Similarly, Wehrmann and Riphaus identified ASA class of 3 or higher, total propofol dose, history of alcohol use and having an emergency endoscopy as independent factors for sedation related complications in patients undergoing advanced procedures.
Given the alarming rates of obesity in the United States, it is believed that the prevalence of obstructive sleep apnea (OSA) may be 10% or higher and in obese adults these numbers could be as high as 25%. Using a previously validated screening tool for OSA [STOP-BANG (SB)], we reported a prevalence rate of patients at risk for OSA of 43.3% in patients undergoing advanced endoscopy procedures. Patients at risk for OSA with a positive SB score (score ≥ 3 of 8) had a higher rate of AMs (20% vs. 6.1%, adjusted relative risk 1.7) and frequency of hypoxemia (12% vs. 5.2%, adjusted relative risk 1.63) compared to those at low risk for OSA. Thus, based on the available data, it appears that ASA class 3 or higher, high BMI, and patients at risk for OSA are factors that place patients undergoing advanced endoscopy procedures at high risk for sedation related complications including airway modifications.
The optimal method for achieving deep sedation in this high risk group of patients is unclear. Propofol may accentuate airway collapse as patients become unresponsive to verbal stimulation (deep sedation). Recent studies suggest that propofol with midazolam and/or opioids may be synergistic in action and therefore the combined application of these drugs may permit smaller doses of each to be used and potentially lead to a reduction in risk of complications and in the dose of propofol needed while retaining the individual advantages of each compound. There is limited data evaluating the synergistic effect of propofol with midazolam and opioids in patients undergoing advanced endoscopy procedures. Ong and colleagues in a randomized controlled trial compared patient sedation and tolerance during ERCP using propofol alone or midazolam, ketamine and pentazocine (sedato-analgesic cocktail) for induction along with propofol for maintenance. Patient tolerance as assessed by visual analog scales by endoscopist and anesthetist were higher in the combination group. Paspatis et al reported higher dosage of intravenous propofol required in patients being sedated with propofol alone compared with that required in patients receiving oral dose of midazolam with propofol for ERCP procedures. In addition, the patients' anxiety levels before the procedure were lower in the combination group. The mean percentage decline in the oxygen saturation during the procedure was significantly greater in propofol alone group. However, these studies excluded patients deemed to be at a high risk for sedation related complications. Patients with ASA class 3 or higher were excluded, the mean BMI was less than 25, and included only patients at average risk for complications associated with sedation.
The significance of synergistic sedation in patients undergoing advanced endoscopy procedures in the high risk patients is unclear. The overall risk of sedation related complications is thought to be higher compared to standard endoscopy due to longer procedure times and the need for relatively deeper levels of sedation.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Missouri
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St. Louis, Missouri, Yhdysvallat, 63110
- Washington University School of Medicine
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Ability to provide informed consent
- Age greater than or equal to 18 years
Presence of at least 1 of the following criteria:
- ASA class 3 or higher
- BMI of 30 or greater
- At risk for OSA (score of 3 or greater on the STOP-BANG screening tool)
Exclusion Criteria:
- drug allergy to Propofol, Benzodiazepines, or Opioids
- patients who received Benzodiazepines or Opioids within 24 hours of the procedure
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Active Comparator: Propofol+Benzo/Opioids
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
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Muut nimet:
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Active Comparator: Propofol Alone
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
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Recommended Propofol doses before considering crossover:
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Number of Participants Who Experience Airway Maneuvers
Aikaikkuna: One day (during procedure)
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In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.
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One day (during procedure)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Participants Who Experience Other Sedation Related Complications
Aikaikkuna: One day (during procedure)
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Compare the number of participants who experience other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups
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One day (during procedure)
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Compare Propofol Doses Between the Two Groups
Aikaikkuna: One day (during procedure)
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The dose of propofol used between the two groups will be compared
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One day (during procedure)
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Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration)
Aikaikkuna: One year
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One year
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Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)
Aikaikkuna: One year
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One year
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Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline)
Aikaikkuna: One year
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One year
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Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication
Aikaikkuna: One year
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One year
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Patient Tolerance as Assessed by Endoscopists
Aikaikkuna: 24-48 hours
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The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded.
Patient tolerance of the procedure will be assessed independently by the endoscopist using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent).
The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.
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24-48 hours
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Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups
Aikaikkuna: 24-48 hours
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The number of participants who experience symptoms of nausea and vomiting in the two groups of patients will be recorded.
This will be recorded during the follow-up phone call made 24-48 hours after the procedure.
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24-48 hours
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Faris Murad, M.D., Washington University School of Medicine
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
- Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.
- Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
- Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
- Rex DK, Heuss LT, Walker JA, Qi R. Trained registered nurses/endoscopy teams can administer propofol safely for endoscopy. Gastroenterology. 2005 Nov;129(5):1384-91. doi: 10.1053/j.gastro.2005.08.014.
- Tishler PV, Larkin EK, Schluchter MD, Redline S. Incidence of sleep-disordered breathing in an urban adult population: the relative importance of risk factors in the development of sleep-disordered breathing. JAMA. 2003 May 7;289(17):2230-7. doi: 10.1001/jama.289.17.2230.
- Rex DK, Deenadayalu VP, Eid E, Imperiale TF, Walker JA, Sandhu K, Clarke AC, Hillman LC, Horiuchi A, Cohen LB, Heuss LT, Peter S, Beglinger C, Sinnott JA, Welton T, Rofail M, Subei I, Sleven R, Jordan P, Goff J, Gerstenberger PD, Munnings H, Tagle M, Sipe BW, Wehrmann T, Di Palma JA, Occhipinti KE, Barbi E, Riphaus A, Amann ST, Tohda G, McClellan T, Thueson C, Morse J, Meah N. Endoscopist-directed administration of propofol: a worldwide safety experience. Gastroenterology. 2009 Oct;137(4):1229-37; quiz 1518-9. doi: 10.1053/j.gastro.2009.06.042. Epub 2009 Jun 21.
- Cohen LB, Dubovsky AN, Aisenberg J, Miller KM. Propofol for endoscopic sedation: A protocol for safe and effective administration by the gastroenterologist. Gastrointest Endosc. 2003 Nov;58(5):725-32. doi: 10.1016/s0016-5107(03)02010-8.
- Cohen LB, Hightower CD, Wood DA, Miller KM, Aisenberg J. Moderate level sedation during endoscopy: a prospective study using low-dose propofol, meperidine/fentanyl, and midazolam. Gastrointest Endosc. 2004 Jun;59(7):795-803. doi: 10.1016/s0016-5107(04)00349-9.
- VanNatta ME, Rex DK. Propofol alone titrated to deep sedation versus propofol in combination with opioids and/or benzodiazepines and titrated to moderate sedation for colonoscopy. Am J Gastroenterol. 2006 Oct;101(10):2209-17. doi: 10.1111/j.1572-0241.2006.00760.x.
- Paspatis GA, Manolaraki M, Xirouchakis G, Papanikolaou N, Chlouverakis G, Gritzali A. Synergistic sedation with midazolam and propofol versus midazolam and pethidine in colonoscopies: a prospective, randomized study. Am J Gastroenterol. 2002 Aug;97(8):1963-7. doi: 10.1111/j.1572-0241.2002.05908.x.
- Vargo JJ, Zuccaro G Jr, Dumot JA, Shermock KM, Morrow JB, Conwell DL, Trolli PA, Maurer WG. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002 Jul;123(1):8-16. doi: 10.1053/gast.2002.34232.
- Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy; Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. No abstract available.
- Reimann FM, Samson U, Derad I, Fuchs M, Schiefer B, Stange EF. Synergistic sedation with low-dose midazolam and propofol for colonoscopies. Endoscopy. 2000 Mar;32(3):239-44. doi: 10.1055/s-2000-134.
- Tohda G, Higashi S, Wakahara S, Morikawa M, Sakumoto H, Kane T. Propofol sedation during endoscopic procedures: safe and effective administration by registered nurses supervised by endoscopists. Endoscopy. 2006 Apr;38(4):360-7. doi: 10.1055/s-2005-921192.
- Riphaus A, Stergiou N, Wehrmann T. Sedation with propofol for routine ERCP in high-risk octogenarians: a randomized, controlled study. Am J Gastroenterol. 2005 Sep;100(9):1957-63. doi: 10.1111/j.1572-0241.2005.41672.x.
- Wehrmann T, Riphaus A. Sedation with propofol for interventional endoscopic procedures: a risk factor analysis. Scand J Gastroenterol. 2008 Mar;43(3):368-74. doi: 10.1080/00365520701679181.
- Yusoff IF, Raymond G, Sahai AV. Endoscopist administered propofol for upper-GI EUS is safe and effective: a prospective study in 500 patients. Gastrointest Endosc. 2004 Sep;60(3):356-60. doi: 10.1016/s0016-5107(04)01711-0.
- Paspatis GA, Manolaraki MM, Vardas E, Theodoropoulou A, Chlouverakis G. Deep sedation for endoscopic retrograde cholangiopancreatography: intravenous propofol alone versus intravenous propofol with oral midazolam premedication. Endoscopy. 2008 Apr;40(4):308-13. doi: 10.1055/s-2007-995346. Epub 2007 Dec 5.
- Cote GA, Hovis RM, Ansstas MA, Waldbaum L, Azar RR, Early DS, Edmundowicz SA, Mullady DK, Jonnalagadda SS. Incidence of sedation-related complications with propofol use during advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Feb;8(2):137-42. doi: 10.1016/j.cgh.2009.07.008. Epub 2009 Jul 14.
- Hiestand DM, Britz P, Goldman M, Phillips B. Prevalence of symptoms and risk of sleep apnea in the US population: Results from the national sleep foundation sleep in America 2005 poll. Chest. 2006 Sep;130(3):780-6. doi: 10.1378/chest.130.3.780.
- Cote GA, Hovis CE, Hovis RM, Waldbaum L, Early DS, Edmundowicz SA, Azar RR, Mullady DK, Jonnalagadda SS. A screening instrument for sleep apnea predicts airway maneuvers in patients undergoing advanced endoscopic procedures. Clin Gastroenterol Hepatol. 2010 Aug;8(8):660-665.e1. doi: 10.1016/j.cgh.2010.05.015. Epub 2010 May 23.
- Seifert H, Schmitt TH, Gultekin T, Caspary WF, Wehrmann T. Sedation with propofol plus midazolam versus propofol alone for interventional endoscopic procedures: a prospective, randomized study. Aliment Pharmacol Ther. 2000 Sep;14(9):1207-14. doi: 10.1046/j.1365-2036.2000.00787.x.
- Ong WC, Santosh D, Lakhtakia S, Reddy DN. A randomized controlled trial on use of propofol alone versus propofol with midazolam, ketamine, and pentazocine "sedato-analgesic cocktail" for sedation during ERCP. Endoscopy. 2007 Sep;39(9):807-12. doi: 10.1055/s-2007-966725.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hermoston sairaudet
- Hengityselinten sairaudet
- Apnea
- Hengityshäiriöt
- Unihäiriöt, luontaiset
- Dyssomniat
- Uniherätyshäiriöt
- Uniapnea-oireyhtymät
- Uniapnea, obstruktiivinen
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Keskushermostoa lamaavat aineet
- Ääreishermoston aineet
- Analgeetit
- Aistijärjestelmän agentit
- Anestesia-aineet, suonensisäiset
- Anestesia, kenraali
- Anestesia-aineet
- Huumausaineet
- Rauhoittavat aineet
- Psykotrooppiset lääkkeet
- Hypnoottiset ja rauhoittavat lääkkeet
- Adjuvantit, anestesia
- Ahdistuneisuutta ehkäisevät aineet
- GABA-modulaattorit
- GABA-agentit
- Fentanyyli
- Midatsolaami
- Propofol
- Analgeetit, opioidit
Muut tutkimustunnusnumerot
- 10-1133
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Naveh Pharma LTDValmis
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Yonsei UniversityValmis
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University of Geneva, SwitzerlandValmisYölliset jalkakrampit | Uniherätyksen siirtymähäiriötSveitsi
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National Taiwan University HospitalRekrytointiTau-jakaumat potilailla, joilla on tauopatia APN-1607 PET-skannauksellaTaiwan
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Ying LiAffiliated Hospital of North Sichuan Medical CollegeIlmoittautuminen kutsusta
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China Medical University HospitalTuntematon
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Pontificia Universidad Catolica de ChileValmisLeikkaus | Anestesia | Anestesian syvyys | VastasyntynytChile
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Universidad del DesarrolloValmisNukutus | Propofolin farmakodynamiikka | Propofoli Target Controlled Infuusio | Tietoisuuden menetys ja tajunnan palautuminen | Propofolin plasmapitoisuusChile
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The Third People's Hospital of ChengduRekrytointiBariatrinen kirurgiaKiina
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Giresun UniversityValmisSilmänsisäinen paine | Anestesia | Levytyrä lannerangaTurkki
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NorthShore University HealthSystemNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekrytointiEturauhasen hyvänlaatuinen liikakasvu (BPH)Yhdysvallat
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University Hospital Hradec KraloveTuntematon