Efficacy of Propofol vs Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane (PROPOREV)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Elective Surgery; Coughing

Treatments: Drug: Intravenous dose of 0.5 mg/kg of propofol; Drug: Intravenous dose of 0.05 mL/kg of saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02932397

CE16.176

Details and patient eligibility

About

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).

Enrollment: 154 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

Propofol

Active Comparator group

Description:

Active drug given to patients as an intravenous dose of 0.5 mg/kg of propofol

Treatment:

Drug: Intravenous dose of 0.5 mg/kg of propofol

Saline solution

Placebo Comparator group

Description:

Placebo drug given to patients as an intravenous dose of 0.05 mL/kg of saline solution (NaCl 0.9%)

Treatment:

Drug: Intravenous dose of 0.05 mL/kg of saline solution