Nasosinusal endoscopic surgery in patients with chronic sinusitis and/or nasal polyposis MedDRA version: 18.0 Level: PT Classification code 10009137 Term: Chronic sinusitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0 Level: PT Classification code 10028755 Term: Nasal polypectomy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: clonidine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLONIDINE
CAS Number: 4205-90-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
Fundació Parc Taulí
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of age >18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have contraindications to the intended nasosinusalendoscopic surgery or to the anaesthesic treatment used in the routine clinical practice of this type of surgery. 2. Patients with impaired coagulation or who are treated with antiaggregants or anticoagulants. 3. Patients with antecedents of coronary arteriopathy or heart rhytm diseases (tachyarhythmias or blockages). 4. Patients that at the time of surgery show signs of hypovolemia, severe hypotension or signs of heart failure. 5. Patients with previous cerebro-vascular event. 6. Patients with chronic treatment with beta-adrenergic blocker agents, or calcium channel blocking agents that have not been withdrawn for a wash-out period equivalent to at least 7 half-lives of the drug before the surgery. 7. Patients for whom their caring physician considers that participation in the study may be clinically detrimental.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare intraoperative bleeding during nasosinusal endoscopic surgery, in patients receiving treatment hypotensive anesthetic based on clonidine or dexmedetomidine as assessed through a modified Boezaart score for surgical field bleeding, evaluated by the external evaluator blinded to the identity of the treatments administered;Secondary Objective: - Surgical field bleeding through the estimates of the amount of blood aspirated during the intervention in mL, according to an hemoglobin correction formula - Surgical field bleeding through the subjective assessment of the intensity of bleeding during surgery by the surgeon - Surgical field bleeding through the subjective assessment of the intensity of bleeding during surgery by an external observer blinded to treatment identity - Duration of the anesthesia and of the surgical procedure - Complications post-procedure (hematoma or orbital emphysema, cerebrospinal fluid leaks, heavy bleeding, etc.) - Time to hospital discharge after surgery;Primary end point(s): The primary endpoint will be the Boezaart bleeding score from the surgical field where Boezaart scale degrees are defined as follows: Grade 1: cadaverous Conditions requiring minimum suction . Grade 2 : Minimum unusual bleeding that requires suction. Grade 3: Active bleeding that requires frequent suckling . Grade 4: Bleeding covers the surgical field after removing the suction and before the instrument can be maneuvered . Grade 5: uncontrolled bleeding . Bleeding outside the nostril to remove the suction. An average score will be calculated for the scale of Boezaart at different times and reclassified into a dichotomous variable of scant bleeding ( ratings equal or below 2 ) and abundant bleeding (ratings greater than 2 ) for the primary analysis of the study.;Timepoint(s) of evaluation of this end point: Every 60 minutes during the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Intraoperative bleeding estimated in milliliters -Assessment of bleeding by both the surgeon and a blind evaluator from the video recording of interventions, every 60 minutes, using the visual analogue scale (VAS ) intensity of the operative field bleeding and the Boezaart scale -Duration Surgery , defined as time from the start of the intervention by the surgeon to the nasal tampooning . -Duration Anesthesia, defined as time from the start of induction to extubation of the patient. -Evaluation of Lund - Mackay scale before surgery -Postoperative surgical and anesthetic complications -Duration of the hospital stay -Assessment of bleeding and late complications of surgery at a follow-up outpatient visit one week after surgery. ;Timepoint(s) of evaluation of this end point: during the surgery | — |
Countries
Spain
Contacts
Public ContactOficina de recerca
Fundació Parc Taulí
Outcome results
None listed