Clinical trial NCT02932397: Efficacy of Propofol vs Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane
Official title: Efficacy of an Intravenous Dose of Propofol Versus Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Surgery
Coughing
Keywords: Ambulatory surgery
Perioperative outcomes
General anesthesia under desflurane
Prevention of coughing
Propofol
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane)
timeFrame: one day, perioperative period
Secondary outcomes:
measure: 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)
timeFrame: one day, perioperative period
measure: Extubation time
timeFrame: one day, perioperative period
measure: Sedation of the patient
timeFrame: one day, perioperative period
measure: Incidence of hypoventilation
timeFrame: one day, perioperative period
measure: Incidence of hypoxic episode
timeFrame: one day, perioperative period
measure: Blood pressure
timeFrame: one day, perioperative period
measure: Heart rate
timeFrame: one day, perioperative period
measure: Agitation of the patient during emergence
timeFrame: one day, perioperative period
measure: Complications
timeFrame: one day, perioperative period
measure: Cumulative incidence of nausea/vomiting
timeFrame: one day, perioperative period
measure: Swallowing pain scores
timeFrame: one day, perioperative period
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: CHUM
name: Pierre Beaulieu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: