- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT06867302
Dexmedetomidin und Agitation nach Nasenoperation
Wirksamkeit von Einzelbolus im Vergleich zu kontinuierlicher Infusion von Dexmedetomidin bei der Minderung der Agitation bei Erwachsenen, die sich einer Nasenoperation unterziehen: Eine prospektive randomisierte Studie
The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Agitation during emergence from general anesthesia is a potentially serious phenomenon that has not been studied in adults as often as in pediatric population. When agitation, serious self-injury, or violence towards the medical team occur, with the risk of aspiration, bleeding, hypoxia, arrhythmias, or simply pulling the endotracheal tubes, removal of drains or catheters. Moreover, agitated patients are not only at risk of developing complications but also, they are labor intensive as they require more medical attention, rescue drugs, and more attending staff till agitation attack safely subside. Recognized risk factors to develop emergence agitation (EA) in adults include ear, nose, and throat surgery, obesity, sevoflurane anesthesia, endotracheal tube, and history of psychological illness. In adults, adjuvants have been co-administered with general anesthesia in order to negate or reduce the incidence of EA especially in patients with identified risk factors.
dexmedetomidine is a highly selective α2 sympatholytic, has been proposed as an attractive candidate for the prophylaxis of EA. By interacting with α2 receptors in locus coeruleus of the pons, Dex exerts its unique anxiolytic, sedative and sympathetic antagonistic action with no respiratory depression. Moreover, it has pain-modulating effect due to interaction with α2 receptor sites in the dorsal horn and supra-spinal regions.
Nevertheless, there have been conflicting data about Dex optimal dose and time of administration when used as prophylaxis against EA. Indeed, different dosing protocols are associated with over sedation, prolonged extubation time, and delayed post-anaesthesia care unit time.
No premedication. Basic general anesthesia monitoring included electrocardiogram, pulse oximetry, non-invasive arterial pressure, and capnography, were recorded every 5 min. Preoxygenation with 100% oxygen for 5 min was performed before fentanyl 1 μg/kg and propofol 1.5-2 mg/ kg, were administered as induction agents. Intubation with facilitated with atracurium besylate 0.5 mg/ kg. The size of endotracheal tubes was 6.5-7.5 mm, for females and males, respectively. Mechanical ventilation was set on 6 ml/kg tidal volume, and respiratory rate was adjusted to keep end-tidal CO2 between 35 and 40 mmHg, in 50% O2/air. All patients at induction were given dexamethasone 4 mg i.v., ondansetron, 4 mg i.v to prevent post-operative nausea and vomiting, plus Ringers lactate solution 6 mg/ kg drip for basic volume maintenance. Blood loss was compensated for with Ringers lactate, intraoperatively. Maintenance of anesthesia was carried out with Isoflurane, regulated at 2-3%, Titrated incremental doses of atropine 0.5 mg, esmolol 10 mg, and ephedrine 6 mg were given i.v., when HR ≤ 45, HR ≥ 120 and MAP ≤ 60, in the mentioned order. ketorolac 30 mg was given I.M., at the time of nasal packing.
When surgery was finished, gentle suction was attempted, non-depolarizing muscle relaxant reverse with atropine, 0.5 mg and neostigmine 0.02 mg/kg was given. Next, isoflurane was turned off and respiration was then converted back to manual ventilation with 100% oxygen at 7 L/min. The patients were not disturbed, except by continual verbal requests to open their eyes. All other stimuli were prevented. Extubation was done when patients were able to breathe spontaneously and interact with verbal demands. When patients were awake, calm, and sedated, they were transferred to the PACU. Patients were discharged from the PACU when their Aldrete score was ≥ 9.
Statistical analysis:
Statistical analysis will be conducted using IBM SPSS Statistics 22 (IBM Corporation, USA). The normal distribution of data will be assessed by the Kolmogorov-Smirnov and Shapiro-Wilk tests. Mean and standard deviation will be used as descriptive statistics for normally distributed numerical variables, while median and interquartile range (25th to 75th percentiles) will be used as descriptive statistics for non-normally distributed numerical variables. In addition, Chi-square test or fisher exact test will be employed to test the significance between categorical variables as appropriate. Independent t test will be employed for numerical data that exhibited normal distribution, whereas the Mann-Whitney test will be used for numerical data that did not adhere to normal distribution. A significance level of p < 0.05 will be deemed to be statistically significant.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Yasser S Mostafa, MD
- Telefonnummer: +2 01010509735
- E-Mail: ysm03@fayoum.edu.eg
Studieren Sie die Kontaktsicherung
- Name: Mohamed A Shawky, MD
- Telefonnummer: +2 0 109 525 4547
- E-Mail: mas14@fayoum.edu.eg
Studienorte
-
-
Faiyum Governorate
-
Al Fayyum, Faiyum Governorate, Ägypten, 63514
- Rekrutierung
- Fayoum University Hospital
-
Kontakt:
- Yasser S Mostafa, MD.
- Telefonnummer: +2 01010509735
- E-Mail: ysm03@fayoum.edu.eg
-
Kontakt:
- Mohamed A Shawky, MD
- Telefonnummer: +2 01095254547
- E-Mail: mas14@fayoum.edu.eg
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- American Society of Anesthesiologist (ASA) Ⅰ or II
- Adults with body mass index (BMI) < 30 Kg/m
- Underwent elective nasal surgery.
Exclusion Criteria:
- Significant comorbidity like hepatic, renal, or cardiac disease
- Auditory impairment
- Cognitive dysfunction
- Substance abuse
- Allergy to the studied medicines
- Planned intensive care admission after the surgery.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Bolus group
single dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery |
An infusion given all through intraoperative time
Andere Namen:
|
|
Experimental: Infusion group
Infusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time |
Single dose given 15 minutes before end of surgery
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)
Zeitfenster: 5 minutes after operation
|
RASS is a 10-point scoring system used to assess patient's level of agitation and sedation: 4 levels for agitation, 1 level for normal (alert and calm), and 5 levels of sedation |
5 minutes after operation
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Intraoperative heart rate
Zeitfenster: Every 15 minutes along operation
|
Beats / minute |
Every 15 minutes along operation
|
|
Intraoperative mean arterial blood pressure
Zeitfenster: Every 15 minutes along operation
|
mmHg |
Every 15 minutes along operation
|
|
Time of first rescue analgesic
Zeitfenster: 5 minutes before first analgesic request
|
in minutes in minutes |
5 minutes before first analgesic request
|
|
Extubation time
Zeitfenster: 3 minutes after removal of endotracheal tube
|
time interval between shutting off anesthetics to extubation (in minutes) |
3 minutes after removal of endotracheal tube
|
|
Postanesthesia care unit time
Zeitfenster: 5 minutes after discharge from recovery unit
|
time interval from admission to PACU till patient scored ≥ 9 on Aldrete scale (ready to discharge) |
5 minutes after discharge from recovery unit
|
|
Incidence of use of midazolam
Zeitfenster: 2 minutes after occurence of emergence agitation
|
Yes or no |
2 minutes after occurence of emergence agitation
|
|
Numerical rating score (NRS)
Zeitfenster: Every 10 min in postanesthesia care unit
|
10 point scale where zero meaning "no pain" and 10 meaning "the worst pain imaginable" |
Every 10 min in postanesthesia care unit
|
|
Total amount of rescue analgesic
Zeitfenster: 24 hours postoperative
|
in milligram |
24 hours postoperative
|
|
Boezaart Surgical Field Grading Scale
Zeitfenster: 2 hours intraoperatively
|
endoscopically using the six-point score (0-5 Scale) where 0 - No bleeding, 1 - Slight bleeding, no suctioning needed, 2 - Slight bleeding, occasional suctioning needed, 3 - Moderate bleeding, frequent suctioning needed, visibility maintained, 4 - Heavy bleeding, constant suctioning needed, visibility impaired, 5 - Severe bleeding, uncontrolled, surgery impossible |
2 hours intraoperatively
|
|
Incidence of bradycardia
Zeitfenster: 2 hours intraoperatively
|
Yes or no |
2 hours intraoperatively
|
|
Incidence of hypotension
Zeitfenster: 2 hours intraoperatively
|
Yes or no when mean arterial blood pressure below 60 mmHg |
2 hours intraoperatively
|
|
Incidence of nausea
Zeitfenster: 24 hours postoperative
|
Yes or no |
24 hours postoperative
|
|
Incidence of vomiting
Zeitfenster: 24 hours postoperative
|
Yes or no |
24 hours postoperative
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Age
Zeitfenster: 5 minutes before entering operation department
|
in years |
5 minutes before entering operation department
|
|
Sex
Zeitfenster: 5 minutes before entering operation department
|
Male of female |
5 minutes before entering operation department
|
|
Weight
Zeitfenster: 5 minutes before entering operation department
|
In kilogram |
5 minutes before entering operation department
|
|
Height
Zeitfenster: 5 minutes before entering operation department
|
In centimeter |
5 minutes before entering operation department
|
|
Duration of surgery
Zeitfenster: 5 minutes after end of surgery
|
In minutes |
5 minutes after end of surgery
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Yasser S Mostafa, MD, Fayoum University
- Studienstuhl: Mohamed A Shawky, MD, Fayoum University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.
- Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.
- Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026.
- Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.
- Zhu M, Wang H, Zhu A, Niu K, Wang G. Meta-analysis of dexmedetomidine on emergence agitation and recovery profiles in children after sevoflurane anesthesia: different administration and different dosage. PLoS One. 2015 Apr 13;10(4):e0123728. doi: 10.1371/journal.pone.0123728. eCollection 2015.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
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
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Psychische Störungen
- Postoperative Komplikationen
- Pathologische Prozesse
- Erkrankungen der Atemwege
- Verwirrtheit
- Neurobehaviorale Manifestationen
- Neurokognitive Störungen
- Otorhinolaryngologische Erkrankungen
- Delirium
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Entstehung Delirium
- Nasenerkrankungen
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Azolen
- Imidazoles
- Dexmedetomidin
Andere Studien-ID-Nummern
- R656
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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