- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02416752
Effect of Remifentanil on the Recovery Profile After Prolonged Head and Neck Surgery
Přehled studie
Postavení
Podmínky
Detailní popis
We have studied 222 of you between the age of 21 and 80 years, over a period of 2 years at Singapore General Hospital, Singapore. All of you were ASA I to II and scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia. The methodology of this observational study was approved by the International review Board at Singapore General Hospital, Singapore. Informed consent was obtained from you prior to the procedure. If you had previous history of either drug or alcohol abuse, have been using opioids for long term, mental disorder with difficult to understand pain scoring system, ASA physical status of III and above, your surgical procedure warranting elective postoperative ventilation you would have been excluded from this study. The study was not randomized and the choice of intra-operative opioids were left to the discretion of anesthesiologist attending you.
You were not premedicated and instructed about 11 point numerical rating score after reaching induction room. Upon arrival in the operating room, you were monitored with EKG, non-invasive arterial pressure and pulse oxymetry. The attending anesthesiologist gave you either Remifentanil or conventional opioids at standard doses from the induction of anesthesia to end of surgery. Sevoflurane, desflurane or isoflurane with oxygen air mixture were utilized to maintain anesthesia at the minimum alveolar concentration of 0.8 to 1.2 . Choice of opioid, volatile agent, muscle relaxants, airway was left to the discretion of the anesthesiologist attending the patient. Parameters including type of volatile anesthetic agent, method of air way establishment, the duration of surgery, the remifentanil used (microgram.kg-1 ) and amount of morphine or fentanyl (microgram.kg-1) were documented. Upon arrival to the PACU you were assessed for the pain.
For the first 15 minutes behavioral score (0 - calm patient with no verbal or behavioral manifestation of pain, 1 - behavioral or verbal expression of pain, and 2 - intense behavioral or verbal manifestation [crying or extreme agitation]) were utilized and subsequently numerical rating scale (NRS) was used for every 5 minutes until discharge from the PACU.
Intravenous morphine or fentanyl was used to treat immediate post-operative pain in PACU till the NRS is less than or equal to 3 as per PACU acute pain management protocol. Maximum NRS of pain, amount of morphine or fentanyl used for rescue analgesia, occurrence of either nausea or vomiting and the antiemetic used was gathered every 15 minutes. Upon discharge from the PACU, total opioids consumed, duration of the PACU (defined by time since admission to decision made for discharge by PACU anesthesiologists, to rule out the prolong PACU stay from other reasons) and occurrence of other potential side effects that affect the quality of recovery such as drowsy, nausea, vomiting, shivering and evidence of respiratory suppression ( desaturation or bradypnea ) were documented.
Our primary outcome was amount of opioids used in PACU and the secondary outcomes were the duration of PACU stay and the adverse effects of remifentanil that influence the recovery as stated above.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Singapore, Singapur, 169608
- Department of Anesthesia Singapore General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Patients with ASA I to II, scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia
Exclusion Criteria:
previous history of either drug or alcohol abuse those who have been using opioids for long term mental disorder with difficult to understand pain scoring system ASA physical status of III and above surgical procedure warranting elective postoperative ventilation
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Case-Control
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
remifentanil group
Group received intra op remifentanil infusion
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The remifentanil infusion was used intra operatively in remifentanil group and intermittent boluses of morphine or fentanyl administered for conventional opioid group
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conventional opioid gropup
Group received only conventional opioids and No infusion of remifentanil
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Amount of opioids used in PACU in morphine equivalent
Časové okno: 90 minutes
|
average time spent in PACU
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90 minutes
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Duration of PACU
Časové okno: 90 minutes
|
average time spent in PACU
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90 minutes
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Adverse effects of remifentanil
Časové okno: 90 minutes
|
Occurrence of following adverse events such Drowsy, nausea, vomiting, shivering and evidence of respiratory suppression ( desaturation or bradypnea ) were documented.
|
90 minutes
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Guignard B, Bossard AE, Coste C, Sessler DI, Lebrault C, Alfonsi P, Fletcher D, Chauvin M. Acute opioid tolerance: intraoperative remifentanil increases postoperative pain and morphine requirement. Anesthesiology. 2000 Aug;93(2):409-17. doi: 10.1097/00000542-200008000-00019.
- Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.
- Thompson JP, Rowbotham DJ. Remifentanil--an opioid for the 21st century. Br J Anaesth. 1996 Mar;76(3):341-3. doi: 10.1093/bja/76.3.341. No abstract available.
- Kaygusuz K, Yildirim A, Kol IO, Gursoy S, Mimaroglu C. Hypotensive anaesthesia with remifentanil combined with desflurane or isoflurane in tympanoplasty or endoscopic sinus surgery: a randomised, controlled trial. J Laryngol Otol. 2008 Jul;122(7):691-5. doi: 10.1017/S0022215107001545. Epub 2008 Feb 21.
- Manola M, De Luca E, Moscillo L, Mastella A. Using remifentanil and sufentanil in functional endoscopic sinus surgery to improve surgical conditions. ORL J Otorhinolaryngol Relat Spec. 2005;67(2):83-6. doi: 10.1159/000084576. Epub 2005 Mar 22.
- Lee M, Silverman SM, Hansen H, Patel VB, Manchikanti L. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011 Mar-Apr;14(2):145-61.
- Yeom JH, Kim KH, Chon MS, Byun J, Cho SY. Remifentanil used as adjuvant in general anesthesia for spinal fusion does not exhibit acute opioid tolerance. Korean J Anesthesiol. 2012 Aug;63(2):103-7. doi: 10.4097/kjae.2012.63.2.103. Epub 2012 Aug 14.
- Lee LH, Irwin MG, Lui SK. Intraoperative remifentanil infusion does not increase postoperative opioid consumption compared with 70% nitrous oxide. Anesthesiology. 2005 Feb;102(2):398-402. doi: 10.1097/00000542-200502000-00024.
- Komatsu R, Turan AM, Orhan-Sungur M, McGuire J, Radke OC, Apfel CC. Remifentanil for general anaesthesia: a systematic review. Anaesthesia. 2007 Dec;62(12):1266-80. doi: 10.1111/j.1365-2044.2007.05221.x.
- von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Bull World Health Organ. 2007 Nov;85(11):867-72. doi: 10.2471/blt.07.045120.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Remi 2011/421/D SGH
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