Verneveld versus intraveneus tranexaminezuur op chirurgische veldkwaliteit bij patiënten die endoscopische sinusoperaties ondergaan
Effect van preoperatief verneveld versus intraveneus tranexaminezuur op de kwaliteit van het operatieveld bij patiënten die endoscopische sinusoperaties ondergaan: een gerandomiseerde, gecontroleerde vergelijkende studie
Intraoperative bleeding is one of the vital problems for anesthesiologists and surgeons, during endoscopic nasal surgery; where the surgical field is very limited and surrounded by vital structures. The tinniest amount of blood in such surgical field can obscure the anatomy and clog the tip of the endoscope, requiring repeated irrigations and suctioning; both of which have traumatic effects on the friable nasal mucosa. Anesthetic techniques to minimize bleeding during endoscopic nasal surgery are of primary importance for a safe and effective procedure, reducing operative time and shortening post-operative recovery.
Good surgical conditions could be achieved with systemic, topical, or regional anesthetic techniques. The use of topical and regional techniques has been gaining popularity in recent years as an alternative to the administration of heavy premedication, high narcotic doses, intravenous lignocaine, clonidine, calcium channel blockers, sodium nitroprusside, beta-adrenergic blockers, and magnesium sulfate, which may produce a lack of alertness, respiratory depression, hypoxia, nausea and vomiting, and delayed recovery.
Recent studies have shown that the use of tranexamic acid could be a safe and effective management option for hemostasis in a wide range of specialties. Tranexamic acid (TXA) is a synthetic lysine derivative that blocks the lysine binding site on plasminogen, thus inactivating its conversion to plasmin and hence attenuating its fibrinolysis effects. When given as a one-time operative systemic dose, it can reduce intraoperative surgical blood loss. More recently, it has been used in its nebulized or topical form to treat bleeding in anatomically sequestered areas. Its use has been described for epistaxis, cancer-related hemoptysis, and post-tonsillectomy bleeding. Though systemic doses of tranexamic acid have proven their efficiency in reducing intraoperative bleeding, other forms of administration have not been widely researched. The use of nebulized form is expected to provide a targeted route and localized effect with reduced systemic side effects. Adverse effects of systemic administration of tranexamic acid include seizures, nausea, vomiting, diarrhea, pulmonary embolism, deep vein thrombosis, anaphylaxis, and other visual disturbance.
The purpose of this study was to assess the effect of pre-emptive nebulized tranexamic acid versus intravenous tranexamic acid on endoscopic visualization and bleeding rate during endoscopic sinus surgeries.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypte
- Faculty of Medicine, Cairo University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age between 18 and 60 years.
- American Society of Anesthesiologists (ASA) class I and II patients.
- Endoscopic sinus surgeries under general anesthesia.
Exclusion Criteria:
- Patient's refusal.
- American Society of Anesthesiologists (ASA) class III or IV patients.
- Underlying uncontrolled hypertension.
- Known history bleeding disorder.
- Patients on anticoagulant therapy.
- Allergy to any of the drugs utilized in this study.
- History of nonsteroidal anti-inflammatory drugs within 48 hours of scheduled surgery.
- Inadvertent intra-operative vascular injury.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Nebulized group
patients will receive nebulized tranexamic acid |
patients will receive a preoperative nebulizer session of 500 mg of tranexamic acid. To ensure the blinding of the participating anesthetist and patient, patients in this group will receive an intravenous drip of 100 ml of 0.9% normal saline. |
|
Actieve vergelijker: Intravenous group
patients will receive intravenous tranexamic acid |
patients will receive a preoperative intravenous drip of TXA at a dose of 15 mg/kg in 100 ml of normal saline. To ensure blinding this group patients will receive 5 ml of 0.9% normal saline nebulizer session. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The mean Wormald intraoperative surgical field grading
Tijdsspanne: 5 hours
|
The mean value of Wormald intraoperative surgical field grading throughout the intraoperative period, where 0 means no bleeding and 10 means severe bleeding with nasal cavity filling rapidly |
5 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Total blood loss
Tijdsspanne: 5 hours
|
calculated by measuring the volume of the blood in the suction reservoir minus the normal saline used to wash the surgical field |
5 hours
|
|
Bleeding rate
Tijdsspanne: 5 hours
|
calculated as the total blood loss divided by the surgical time |
5 hours
|
|
Operation time
Tijdsspanne: 5 hours
|
Time starting from induction of anesthesia till completion of the surgical procedure |
5 hours
|
|
Postoperative complications
Tijdsspanne: 24 hours
|
nausea, vomiting, anaphylaxis, visual impairment, seizure, venous thromboembolism |
24 hours
|
|
postoperative nasal bleeding
Tijdsspanne: 48 hours
|
Incidence of postoperative nasal bleeding |
48 hours
|
|
postoperative intervention
Tijdsspanne: 48 hours
|
Incidence of the need for postoperative intervention to control nasal bleeding |
48 hours
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Kareem MA Nawwar, M.D., Cairo University
- Studie stoel: Nevan M Abbas Elmekawy, M.D., Cairo University
- Studie directeur: Tamer M Khair, M.D., Cairo University
- Hoofdonderzoeker: Nadia E M Gaballah, M.Sc., Cairo University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
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
Andere studie-ID-nummers
- MD-206-2024
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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