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

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

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).

Study Overview

• Status: Completed
• Conditions: Coughing; Elective Surgery
• Intervention / Treatment: Drug: Intravenous dose of 0.5 mg/kg of propofol; Drug: Intravenous dose of 0.05 mL/kg of saline solution

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
      • CHUM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; Active drug given to patients as an intravenous dose of 0.5 mg/kg of propofol	Drug: Intravenous dose of 0.5 mg/kg of propofol
Placebo Comparator: Saline solution; Placebo drug given to patients as an intravenous dose of 0.05 mL/kg of saline solution (NaCl 0.9%)	Drug: Intravenous dose of 0.05 mL/kg of saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Extubation time	Interval between discontinuation of desflurane and extubation	one day, perioperative period
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
Incidence of hypoventilation	incidence of hypoventilation (breathing rate < 8/min)	one day, perioperative period
Incidence of hypoxic episode	incidence of hypoxic episode (oxygen saturation < 90%)	one day, perioperative period
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
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
Agitation of the patient during emergence	Note the possible agitation of the patient during emergence	one day, perioperative period
Complications	Describe potential complications secondary to the bolus of the substance under study at the emergence	one day, perioperative period
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
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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Pierre Beaulieu, MD, PhD, CHUM

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Propofol; Ambulatory surgery; Perioperative outcomes; General anesthesia under desflurane; Prevention of coughing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: CE16.176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO