search
Back to results

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

Primary Purpose

Elective Surgery, Coughing

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intravenous dose of 0.5 mg/kg of propofol
Intravenous dose of 0.05 mL/kg of saline solution
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elective Surgery focused on measuring Ambulatory surgery, Perioperative outcomes, General anesthesia under desflurane, Prevention of coughing, Propofol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHUM

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Propofol

Saline solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Extubation time
Interval between discontinuation of desflurane and extubation
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
Incidence of hypoventilation
incidence of hypoventilation (breathing rate < 8/min)
Incidence of hypoxic episode
incidence of hypoxic episode (oxygen saturation < 90%)
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
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
Agitation of the patient during emergence
Note the possible agitation of the patient during emergence
Complications
Describe potential complications secondary to the bolus of the substance under study at the emergence
Cumulative incidence of nausea/vomiting
Calculate cumulative incidence of nausea/vomiting between extubation and 30 minutes after the admission in the recovery room
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

Full Information

First Posted
October 5, 2016
Last Updated
January 23, 2018
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
search

1. Study Identification

Unique Protocol Identification Number
NCT02932397
Brief Title
Efficacy of Propofol vs Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane
Acronym
PROPOREV
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Surgery, Coughing
Keywords
Ambulatory surgery, Perioperative outcomes, General anesthesia under desflurane, Prevention of coughing, Propofol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Active drug given to patients as an intravenous dose of 0.5 mg/kg of propofol
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Placebo drug given to patients as an intravenous dose of 0.05 mL/kg of saline solution (NaCl 0.9%)
Intervention Type
Drug
Intervention Name(s)
Intravenous dose of 0.5 mg/kg of propofol
Intervention Type
Drug
Intervention Name(s)
Intravenous dose of 0.05 mL/kg of saline solution
Primary Outcome Measure Information:
Title
Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane)
Description
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
Time Frame
one day, perioperative period
Secondary Outcome Measure Information:
Title
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)
Description
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
Time Frame
one day, perioperative period
Title
Extubation time
Description
Interval between discontinuation of desflurane and extubation
Time Frame
one day, perioperative period
Title
Sedation of the patient
Description
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
Time Frame
one day, perioperative period
Title
Incidence of hypoventilation
Description
incidence of hypoventilation (breathing rate < 8/min)
Time Frame
one day, perioperative period
Title
Incidence of hypoxic episode
Description
incidence of hypoxic episode (oxygen saturation < 90%)
Time Frame
one day, perioperative period
Title
Blood pressure
Description
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
Time Frame
one day, perioperative period
Title
Heart rate
Description
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
Time Frame
one day, perioperative period
Title
Agitation of the patient during emergence
Description
Note the possible agitation of the patient during emergence
Time Frame
one day, perioperative period
Title
Complications
Description
Describe potential complications secondary to the bolus of the substance under study at the emergence
Time Frame
one day, perioperative period
Title
Cumulative incidence of nausea/vomiting
Description
Calculate cumulative incidence of nausea/vomiting between extubation and 30 minutes after the admission in the recovery room
Time Frame
one day, perioperative period
Title
Swallowing pain scores
Description
Evaluate swallowing pain scores evaluated using a verbal simple numeric scale (0 = no pain et 10 = worst pain imaginable) 30 min after extubation
Time Frame
one day, perioperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: Ear, nose and throat (ENT) surgery, thoracic and neurological surgery ; Participation refusal; Patient allergic to or presenting a contraindication to propofol; Patient with a tracheostomy; Chronic coughing, i.e. daily cough for 8 weeks or more; Asthma / severe or exacerbated chronic obstructive pulmonary disease (COPD); Recent respiratory tracts infection (< 4 weeks); Hemostasis disorders; Patient known for a non-secure cerebral aneurysm; Patient known for a difficult intubation (grade 3 or 4); Patient suffering from mental, neurological, or severe cardiovascular disease; Pregnant or breastfeeding women; Patients with deafness and/or unable to have conversations in a normal voice; Patient with language barrier (not speaking French, nor English); Patient suffering from dementia or patient under guardianship.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Beaulieu, MD, PhD
Organizational Affiliation
CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs