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

Elective Surgery Clinical Trial

— PROPOREV  

Official title:

Efficacy of an Intravenous Dose of Propofol Versus Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932397
• Other study ID #: CE16.176
• Status: Completed
• Phase: N/A
• First received: October 5, 2016
• Last updated: January 23, 2018
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cough
• Coughing
• Elective Surgery

Intervention

Drug:
• Intravenous dose of 0.5 mg/kg of propofol

• Intravenous dose of 0.05 mL/kg of saline solution

Locations

Country	Name	City	State
Canada	CHUM	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane)	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	one day, perioperative period
Secondary	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)	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	one day, perioperative period
Secondary	Extubation time	Interval between discontinuation of desflurane and extubation	one day, perioperative period
Secondary	Sedation of the patient	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	one day, perioperative period
Secondary	Incidence of hypoventilation	incidence of hypoventilation (breathing rate < 8/min)	one day, perioperative period
Secondary	Incidence of hypoxic episode	incidence of hypoxic episode (oxygen saturation < 90%)	one day, perioperative period
Secondary	Blood pressure	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	one day, perioperative period
Secondary	Heart rate	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	one day, perioperative period
Secondary	Agitation of the patient during emergence	Note the possible agitation of the patient during emergence	one day, perioperative period
Secondary	Complications	Describe potential complications secondary to the bolus of the substance under study at the emergence	one day, perioperative period
Secondary	Cumulative incidence of nausea/vomiting	Calculate cumulative incidence of nausea/vomiting between extubation and 30 minutes after the admission in the recovery room	one day, perioperative period
Secondary	Swallowing pain scores	Evaluate swallowing pain scores evaluated using a verbal simple numeric scale (0 = no pain et 10 = worst pain imaginable) 30 min after extubation	one day, perioperative period