Nasosinusal endoscopic surgery in patients with chronic sinusitis and/or nasal polyposis MedDRA version: 14.1 Level: PT Classification code 10028756 Term: Nasal polyps System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: PT Classification code 10052967 Term: Nasopharyngeal surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10009137 Term: Chronic sinusitis System Organ C
Conditions
Interventions
Product Name: clonidine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLONIDINE
CAS Number: 4205-90-7
Current Sponsor code: Not applicable
Other descriptive name: Not applicable
Con
Sponsors
Fundació Parc Taulí
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of age >18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have contraindications to the intended nasosinusal endoscopic surgery or to the anaesthesic treatment used in the routine clinical practice of this type of surgery. Pregnant women, women who are breast-feeding. Patients with impaired coagulation or who are treated with antiaggregants or anticoagulants. Patients with antecedents of coronary arteriopathy or heart rhytm diseases (tachyarhythmias or blockages). Patients that at the time of surgery show signs of hypovolemia, severe hypotension or signs of heart failure. Previous cerebro-vascular event. Chronic treatment with beta-adrenergic blocker agents, or calcium channel blocking agents that have not been withdrawn for a wash-out period equivalent to at least 7 half-lives of the drug before the surgery. 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 between two anesthetic schemes routinely used in clinical practice: one based on opioid derivatives and one that includes preoperative administration of clonidine, as assessed through a modified Boezaart score for surgical field bleeding.;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 - Validation of assessments of the surgical field through the unmodified and modified Boezaart score and with the Wormald scale.;Primary end point(s): Surgical field bleeding as assessed by a modified Boezaart scale every 60 minutes; the average score for the assessments at different time points will be calculated and this will be recoded for the main study assessment to a dichotomic variable, where mild bleeding will be scores lower or equal to 2 and intense bleeding will be those scores higher than 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Intraoperative bleeding in mL where blood loss is measured as Hb (g dl-1) x V (ml) / Hbm (g dl-1) Bleeding assessment as measured by the surgeon and a third assessor who will be blind to treatment assignation, through visualization of video recorded surgery, through different scales assessed every 60 minutes: Visual analogue scale (VAS) of bleeding intensity Boezaart scale Wormald scale Duration of the procedure, assessed as time from surgeon starting the procedure until the nasal tampooning. Duration of anaesthesia, defined as the time lapsed between induction until extubation. Postoperative, intraoperative and anaesthetic complications Duration of the hospital stay Assessment at a follow-up outpatient visit one week after surgery: bleeding and late somplications of surgery Proportion of patients with AE Proportion of patients with AE with suspected relationship to stuyd medication;Timepoint(s) of evaluation of this end point: Every 60 minutes during the surgical procedure. Follow-up one week after surgery. | — |
Countries
Spain
Contacts
Public ContactOficina de Recerca
Fundació Parc Taulí
Outcome results
None listed