- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03187717
Total Intravenous Anesthesia and Inhalation Anesthesia
The Comparison of Total Intravenous Anesthesia and Inhalation Anesthesia Procedures Used in Oral and Maxillofacial Surgeries in View of Postoperative Complications and the Recovery Period
The aim of us is to define the incidence of postoperative complications and recovery time in view of two anesthesia procedures.
During the period between 01.01.2016 and 01.01.2017, totally 583 patients were included in the study, who had oral and maxillofacial surgeries. Anesthesia types were determined as total intravenous anesthesia (TIVA) and inhalation anesthesia (IA). Postoperative complications and recovery period were determined as tachycardia, bradycardia, hypertension, hypotension, recovery time, additional analgesia, nausea-vomiting. Both anesthesia procedures were compared in terms of these postoperative complications and recovery time.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Totally American Society of Anesthesiologists (ASA) I-II, 18-60 ages, 583 patients who had had oral and maxillofacial operations for 30 minutes and over with TIVA and IA methods between 1st Jan, 2016 and 1st Jan, 2017. The ones who had insufficient data in their files and who were conscious / superficial sedation patients were excluded from the study. The patients were allocated to two groups as TIVA and IA. The total intravenous anesthesia group was named "Group TIVA" , and the volatile anesthesia group was named "Group IA".
All the patients were opened vascular access after being taken into the operation room and were given anesthesia induction with 1 µg/kg fentanyl, 2 mg/kg propofol and 0,8 mg/kg rocuronium. The patients in Group IA were given 1-2% volume sevoflurane in 50% oxygen and 50% nitrous oxide during maintenance of anesthesia, while the patients in group TIVA were applied 4-10 mg/kg/h propofol and 0.05-0.1 µg/kg fentanyl IV infusion with 50% oxygen and 50% air. While being woken up, each patient was given 0.3 mg/kg tenoxicam for analgesia and 0.2 mg/kg metoclopramide for nausea-vomiting prophylaxis in a routine way. Each patient was taken into recovery room after extubation and pulse rate, non-invasive blood pressure (NIBP) and oxygen saturation monitorization were done. Postoperative complication and vital finding tracks of each patient were done as usual and were recorded.
Studientyp
Einschreibung (Tatsächlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Totally American Society of Anesthesiologists (ASA) I-II, 18-60 ages patients who had had oral and maxillofacial operations for 30 minutes and over with TIVA and IA procedures between 1st Jan, 2016 and 1st Jan, 2017.
Exclusion Criteria:
- The ones who had insufficient data in their files and who were conscious/superficial sedation patients were excluded from the study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Fallkontrolle
- Zeitperspektiven: Retrospektive
Kohorten und Interventionen
Gruppe / Kohorte |
---|
TIVA (Total intravenous anesthesia)
Group TIVA; patients who used intravenous anesthesia procedure
|
IA (Inhalation anesthesia)
Group IA; patients who used inhalation anesthesia procedure
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Postoperative pain
Zeitfenster: 1 year
|
Visual Analog Scale (VAS)
|
1 year
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Ozlem Kocaturk, MD, Faculty of Dentistry, Adnan Menderes University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Gecaj-Gashi A, Hashimi M, Sada F, Baftiu N, Salihu S, Terziqi H, Bruqi B. Propofol vs isoflurane anesthesia-incidence of PONV in patients at maxillofacial surgery. Adv Med Sci. 2010;55(2):308-12. doi: 10.2478/v10039-010-0033-4.
- Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.
- Jellish WS, Lien CA, Fontenot HJ, Hall R. The comparative effects of sevoflurane versus propofol in the induction and maintenance of anesthesia in adult patients. Anesth Analg. 1996 Mar;82(3):479-85. doi: 10.1097/00000539-199603000-00009.
- Watson KR, Shah MV. Clinical comparison of 'single agent' anaesthesia with sevoflurane versus target controlled infusion of propofol. Br J Anaesth. 2000 Oct;85(4):541-6. doi: 10.1093/bja/85.4.541.
- Bharti N, Chari P, Kumar P. Effect of sevoflurane versus propofol-based anesthesia on the hemodynamic response and recovery characteristics in patients undergoing microlaryngeal surgery. Saudi J Anaesth. 2012 Oct-Dec;6(4):380-4. doi: 10.4103/1658-354X.105876.
- Adams HA, Schmitz CS, Baltes-Gotz B. [Endocrine stress reaction, hemodynamics and recovery in total intravenous and inhalation anesthesia. Propofol versus isoflurane]. Anaesthesist. 1994 Nov;43(11):730-7. doi: 10.1007/s001010050115. German.
- Joo HS, Perks WJ. Sevoflurane versus propofol for anesthetic induction: a meta-analysis. Anesth Analg. 2000 Jul;91(1):213-9. doi: 10.1097/00000539-200007000-00040.
- Dashfield AK, Birt DJ, Thurlow J, Kestin IG, Langton JA. Recovery characteristics using single-breath 8% sevoflurane or propofol for induction of anaesthesia in day-case arthroscopy patients. Anaesthesia. 1998 Nov;53(11):1062-6. doi: 10.1046/j.1365-2044.1998.00571.x.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- OzlemKocaturk
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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