- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT06867302
DexMedetomidine en agitatie na nasale chirurgie
Effectiviteit van enkele bolus versus continue infusie van dexmedetomidine bij het verzachten van agitatie bij volwassenen die een nasale chirurgie ondergaan: een prospectieve gerandomiseerde 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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Yasser S Mostafa, MD
- Telefoonnummer: +2 01010509735
- E-mail: ysm03@fayoum.edu.eg
Studie Contact Back-up
- Naam: Mohamed A Shawky, MD
- Telefoonnummer: +2 0 109 525 4547
- E-mail: mas14@fayoum.edu.eg
Studie Locaties
-
-
Faiyum Governorate
-
Al Fayyum, Faiyum Governorate, Egypte, 63514
- Werving
- Fayoum University Hospital
-
Contact:
- Yasser S Mostafa, MD.
- Telefoonnummer: +2 01010509735
- E-mail: ysm03@fayoum.edu.eg
-
Contact:
- Mohamed A Shawky, MD
- Telefoonnummer: +2 01095254547
- E-mail: mas14@fayoum.edu.eg
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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:
|
|
Experimenteel: 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:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Intraoperative heart rate
Tijdsspanne: Every 15 minutes along operation
|
Beats / minute |
Every 15 minutes along operation
|
|
Intraoperative mean arterial blood pressure
Tijdsspanne: Every 15 minutes along operation
|
mmHg |
Every 15 minutes along operation
|
|
Time of first rescue analgesic
Tijdsspanne: 5 minutes before first analgesic request
|
in minutes in minutes |
5 minutes before first analgesic request
|
|
Extubation time
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 2 minutes after occurence of emergence agitation
|
Yes or no |
2 minutes after occurence of emergence agitation
|
|
Numerical rating score (NRS)
Tijdsspanne: 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
Tijdsspanne: 24 hours postoperative
|
in milligram |
24 hours postoperative
|
|
Boezaart Surgical Field Grading Scale
Tijdsspanne: 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
Tijdsspanne: 2 hours intraoperatively
|
Yes or no |
2 hours intraoperatively
|
|
Incidence of hypotension
Tijdsspanne: 2 hours intraoperatively
|
Yes or no when mean arterial blood pressure below 60 mmHg |
2 hours intraoperatively
|
|
Incidence of nausea
Tijdsspanne: 24 hours postoperative
|
Yes or no |
24 hours postoperative
|
|
Incidence of vomiting
Tijdsspanne: 24 hours postoperative
|
Yes or no |
24 hours postoperative
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Age
Tijdsspanne: 5 minutes before entering operation department
|
in years |
5 minutes before entering operation department
|
|
Sex
Tijdsspanne: 5 minutes before entering operation department
|
Male of female |
5 minutes before entering operation department
|
|
Weight
Tijdsspanne: 5 minutes before entering operation department
|
In kilogram |
5 minutes before entering operation department
|
|
Height
Tijdsspanne: 5 minutes before entering operation department
|
In centimeter |
5 minutes before entering operation department
|
|
Duration of surgery
Tijdsspanne: 5 minutes after end of surgery
|
In minutes |
5 minutes after end of surgery
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Yasser S Mostafa, MD, Fayoum University
- Studie stoel: Mohamed A Shawky, MD, Fayoum University
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Postoperatieve complicaties
- Pathologische processen
- Ziekten van de luchtwegen
- Verwardheid
- Neurologische gedragsmanifestaties
- Neurocognitieve stoornissen
- KNO-ziekten
- Delirium
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Ontstaan Delirium
- Neus Ziekten
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Azoles
- Imidazolen
- Dexmedetomidine
Andere studie-ID-nummers
- R656
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .