Arthroscopy for Temporomandibular
Conditions
Interventions
Trade Name: Propofol
Product Name: PROPOFOL
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: PROPOFOL
Other descriptive name: PROPOFOL
Concentration unit: mg/ml milligram(s)/m
Sponsors
SERVICIO DE ANESTESIOLOGÍA Y REANIMACIÓN HOSPITAL UNIVERSITARIO LA PAZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients undergoing arthroscopy of the temporomandibular joint due to dysfunction of the joint. • Patients older than 18 and younger than 99 years. • ASA Classification I-II-III • Patients who have signed informed consent • In the case of women of childbearing age, they should have a negative pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: • Patients with known allergy to some of the drugs used. • Patients with intellectual or psychiatric problems that prevent them from fully understanding informed consent. • Patients with severe heart disease (NYHA Grade III and IV) • Severe renal disease (creatinine clearance = 30 mL / min) • Liver disease (Child-Pugh Grade C) • Patients with type I or II diabetes mellitus, compensated or decompensated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of postoperative nausea and vomiting in temporomandibular joint arthroscopy comparing 3 anesthetic maintenance regimens used in routine clinical practice.;Secondary Objective: 1. Evaluation of the patient's comfort, in terms of pain, delayed awakening, stay in a post-anesthetic recovery unit (URPA) and hospital. 2. Determination of the incidence of cardiovascular events, respiratory events (such as episodes of bronchoconstriction) and intraoperative awakenings.;Primary end point(s): Presence of PONV at 2, 6 and 24 postoperative hours, taking into account the intensity scale of PONV and the visual analog scale of nausea.;Timepoint(s) of evaluation of this end point: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Demographic variables: • Sex • Age • Weight • Height • Body mass index • Toxic habits (tobacco and enolics), • Clinical Variables: ? Anesthetic risk ASA (American Society of Anesthesiologists) • Mean arterial pressure and heart rate at admission to the plant. • Usual medication • History of postoperative dizziness, nausea and vomiting • Medical and surgical history • Duration of anesthesia and surgery • Temperature • Volume and type of fluids administered • Time from drug discontinuation to extubation. • Time to wake up from stopping anesthetic drugs • Administered drugs (type and dose) • Time to start: oral tolerance and mobilization • Length of stay in Post Anesthesia Recovery Unit (URPA) and length of hospital stay • Pain through visual analog scale (EVA) • Postoperative analgesia (rescue analgesic requirements) • Need for antiemetic medication;Timepoint(s) of evaluation of this end point: 24 hours | — |
Countries
Spain
Contacts
Public ContactSERVICIO DE ANESTESIOLOGÍA Y REANIM
SERVICIO DE ANESTESIOLOGÍA Y REANIMACIÓN HOSPITAL UNIVERSITARIO LA PAZ
Outcome results
None listed