Coblation Turbinoplasty, Intraoperative Bleeding
Conditions
Brief summary
Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. In this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors phenylephrine and systemic antifibrinolytic agent tranexamic acid.
Interventions
phenylephrine-soaked pack using the whole 5 ml of the solution provided with.5% phenylephrine will be applied after induction of surgery and intubation, 15 minutes before surgery. 100 ml of normal saline will be given.
DRUGintravenous tranexamic acid
patients will receive intravenous Single dose of tranexamic acid 15 mg/kg in 100 mL normal saline over 10 minutes. Saline-soaked pack will be applied.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I and II * Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy
Exclusion criteria
* Known allergy to study drugs. * History of coagulopathy or bleeding disorders. * Patients with hypertension or ischemic heart disease. * patients on anticoagulants, antiplatelets or NSAIDs * history of deep vein thrombosis, stroke or peripheral vascular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| surgical field scale | intraoperativel | the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding 1. = Minimal bleeding: Not a surgical nuisance and no suction required 2. = Mild bleeding: Occasional suction required, but does not affect dissection 3. = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4. = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5. = Massive bleeding: Prevent dissection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Blood loss | intraoperative | — |
| Duration of surgery | the duration from induction of anesthesia till extubation | — |
| Avoidance of postoperative nasal packing | immediately after the surgey | if the patient can be spared from postoperatiove nasal pack inserted for controllling bleeding |
| Intra-operative and Postoperative complications | intraoperative and 24 hours postoperative | Complications such as nausea, vomiting, hypotnsion, hypertension, hemorraghic or thrombotic manifestations for 24 hours |
Contacts
Primary ContactAhmed A Mohammed, M.D.
Outcome results
None listed