Het bestuderen en vergelijken van cocaïne, tetracaïne-oxymetazoline en ropivacaïne-oxymetazoline wat betreft de peroperatieve decongestie en hemostasis en postoperatieve analgesie die zij bieden bij FESS. Study and compare the peroperative…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The surgeon will range the operative site for decongestion and hemostasis using
a numeric rating scale (NRS 0-10).
The perooperative bloodloss, the amount of extra ultracaine-epinefrine
injections and the operation-time will be noted
Pain (+medication) nausea/vomiting (+medication), heartrate and bloodpressure,
drowsiness and bloodloss will be registrated till 24 hours postoperatively
(t=0,1 2, 6, 12, 18 and 24h)
Secondary outcome
Satisfaction of the patient about the treatment
Complications
Background summary
Before the start of a FESS-operation patients receive endonasal gauzes with
cocaine, because of cocaines vasoconstrictive and analgetic qualities. However,
cocaine can have cardiotoxic side-effects.
Proberly, an other topical medication can be equipotential for the
vasocontrictive and analgetic effect with less side-effects.
Study objective
Het bestuderen en vergelijken van cocaïne, tetracaïne-oxymetazoline en
ropivacaïne-oxymetazoline wat betreft de peroperatieve decongestie en
hemostasis en postoperatieve analgesie die zij bieden bij FESS.
Study and compare the peroperative decongestive and hemostatic effects and
postoperative analgesia of cocaine, tetracain-oxymetazolin and
ropivacain-oxymetazolin
Study design
Observational , double-blinded, randomised interventionstudie (pilot)
Intervention
The surgeon places intranasal gauzes with cocaine, ropivacaine-oxymetazolin or
tetracaine-oxymetazolin during 15 minutes
Study burden and risks
Almost the entire treatment are routine-activities by FESS-operation.
The only extra intervention is placement of a second infuse during anesthesia.
A little hematoma can remain.
Weg door Jonkerbos 100.
6532 SZ Nijmegen
Nederland
Weg door Jonkerbos 100.
6532 SZ Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
First FESS-operation
Age: >=18years
ASA 1-3 (patient classification as by the American Society of Anesthesiology)
Competent and the Dutch language understanding in word and reading
Exclusion criteria
Perioperative intake anticoagulants
Chronic painsyndrom
Pregnancy
Allergy for lokal anesthetics
Psychiatric disorder with disease of reality experience
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-002020-29-NL |
| CCMO | NL23108.091.08 |