Coughing, Elective Surgery
Conditions
Keywords
Ambulatory surgery, Perioperative outcomes, General anesthesia under desflurane, Prevention of coughing, Propofol
Brief summary
Emergence of general anesthesia is a critical period, in the same way as the induction of anesthesia, during which several adverse events may occur. Extubation may even be more difficult than the intubation, with a higher respiratory complications rate. Among these, cough is common and expected. It can be associated with significant complications including hypertension, tachycardia, increased intracranial pressure, bleeding at the surgical site or even wound dehiscence. The incidence of coughing during emergence of general anesthesia varies depending on the type of airway instrumentation, the population under study, agents used for the maintenance of the anesthesia and techniques used to prevent coughing. In the literature, the incidence of coughing during emergence of general anesthesia under endotracheal intubation varies from 38 to 96%. In our center, the incidence of coughing during emergence of general anesthesia under desflurane and endotracheal intubation is 30 % according to a local preliminary study. Propofol is well-known to inhibit airway reflexes. Total intravenous anesthesia (TIVA) is associated with a lower incidence of coughing compared to inhalated anesthesia. The efficacy of propofol at a subhypnotic dose to reduce coughing during emergence has recently been demonstrated in patients undergoing nasal surgery under sevoflurane. However, the most effective antitussive dose remains unknown and its efficacy during anesthesia under desflurane has not yet been demonstrated. Propofol is rapidly available, simple to administer and has an interesting pharmacological profile, among others due to its short half-life. The aim of this study is to evaluate if an intravenous bolus of 0.5 mg/kg of propofol is more effective than placebo administration to decrease the incidence of coughing during emergence of general anesthesia under desflurane (PROPOREV). Propofol could also reduce the incidence of postoperative nausea and vomiting (PONV).
Interventions
DRUGIntravenous dose of 0.5 mg/kg of propofol
DRUGIntravenous dose of 0.05 mL/kg of saline solution
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged between 18 to 80 years undergoing elective surgery under general anesthesia with an orotracheal intubation; * Patients of American Society of Anesthesiologists (ASA) I to III inclusively at the preoperative evaluation * Patients affiliated to a medical insurance system.
Exclusion criteria
1. Ear, nose and throat (ENT) surgery, thoracic and neurological surgery ; 2. Participation refusal; 3. Patient allergic to or presenting a contraindication to propofol; 4. Patient with a tracheostomy; 5. Chronic coughing, i.e. daily cough for 8 weeks or more; 6. Asthma / severe or exacerbated chronic obstructive pulmonary disease (COPD); 7. Recent respiratory tracts infection (\< 4 weeks); 8. Hemostasis disorders; 9. Patient known for a non-secure cerebral aneurysm; 10. Patient known for a difficult intubation (grade 3 or 4); 11. Patient suffering from mental, neurological, or severe cardiovascular disease; 12. Pregnant or breastfeeding women; 13. Patients with deafness and/or unable to have conversations in a normal voice; 14. Patient with language barrier (not speaking French, nor English); 15. Patient suffering from dementia or patient under guardianship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane) | one day, perioperative period | Incidence of coughing during emergence of general anesthesia (between discontinuation of desflurane and MAC of 0.15 of desflurane) and its severity based on a 4-grade scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extubation time | one day, perioperative period | Interval between discontinuation of desflurane and extubation |
| Sedation of the patient | one day, perioperative period | Sedation of the patient two, five and ten minutes following extubation, then at 15 minutes interval in the recovery room, based on the Observer's Assessment of Alertness/Sedation Scale (OAA/A), until 30 minutes after the admission in the recovery room |
| Incidence of hypoventilation | one day, perioperative period | incidence of hypoventilation (breathing rate \< 8/min) |
| Incidence of hypoxic episode | one day, perioperative period | incidence of hypoxic episode (oxygen saturation \< 90%) |
| Blood pressure | one day, perioperative period | Measurement of blood pressure before the induction and during emergence (every 5 min) in order to calculate incidence of fluctuation of non invasive blood pressure and heart rate of more than 20% between the values before induction of anesthesia until 10 min after extubation |
| Incidence of coughing (between discontinuation of desflurane, MAC of 0.1 and 0.2 of desflurane, at extubation, as well as 5 and 10 min after extubation) | one day, perioperative period | Incidence of coughing during emergence of general anesthesia (between MAC of 0.15 of desflurane and until 10 min after extubation) and its severity based on a 4-grade scale |
| Agitation of the patient during emergence | one day, perioperative period | Note the possible agitation of the patient during emergence |
| Complications | one day, perioperative period | Describe potential complications secondary to the bolus of the substance under study at the emergence |
| Cumulative incidence of nausea/vomiting | one day, perioperative period | Calculate cumulative incidence of nausea/vomiting between extubation and 30 minutes after the admission in the recovery room |
| Swallowing pain scores | one day, perioperative period | Evaluate swallowing pain scores evaluated using a verbal simple numeric scale (0 = no pain et 10 = worst pain imaginable) 30 min after extubation |
| Heart rate | one day, perioperative period | Measurement of heart rate before the induction and during emergence (every 5 min) in order to calculate incidence of fluctuation of non invasive blood pressure and heart rate of more than 20% between the values before induction of anesthesia until 10 min after extubation |
Countries
Canada
Outcome results
None listed