Elective SurgeryPROPOREVNCT02932397
Efficacy of Propofol vs Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane
A study testing Intravenous dose of 0.5 mg/kg of propofol and Intravenous dose of 0.05 mL/kg of saline solution in people with Elective Surgery and Coughing, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elective Surgery, Coughing
- What is being tested?
- Intravenous dose of 0.5 mg/kg of propofol and Intravenous dose of 0.05 mL/kg of saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
- Conditions
- Elective Surgery, Coughing
- Being tested
- Intravenous dose of 0.5 mg/kg of propofol, Intravenous dose of 0.05 mL/kg of saline solution
- Keywords
- Ambulatory surgery, Perioperative outcomes, General anesthesia under desflurane, Prevention of coughing, Propofol
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous dose of 0.5 mg/kg of propofolDrug
Intravenous dose of 0.05 mL/kg of saline solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Active drug given to patients as an intravenous dose of 0.5 mg/kg of propofol Receives: Drug: Intravenous dose of 0.5 mg/kg of propofol |
| Saline solution | Placebo comparator | Placebo drug given to patients as an intravenous dose of 0.05 mL/kg of saline solution (NaCl 0.9%) Receives: Drug: Intravenous dose of 0.05 mL/kg of saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day, perioperative period
Secondary outcomes (11)
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
Measured: one day, perioperative period
Extubation time
Interval between discontinuation of desflurane and extubation
Measured: 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
Measured: one day, perioperative period
Incidence of hypoventilation
incidence of hypoventilation (breathing rate < 8/min)
Measured: one day, perioperative period
Incidence of hypoxic episode
incidence of hypoxic episode (oxygen saturation < 90%)
Measured: 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
Measured: 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
Measured: one day, perioperative period
Agitation of the patient during emergence
Note the possible agitation of the patient during emergence
Measured: one day, perioperative period
Complications
Describe potential complications secondary to the bolus of the substance under study at the emergence
Measured: 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
Measured: 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
Measured: one day, perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Beaulieu, MD, PhD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932397
- Sponsor's protocol ID
- CE16.176
- Acronym
- PROPOREV
- Status last verified
- Jan 2018
- First submitted
- 5 Oct 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ouellet MF, Moore A, Williams S, Girard F, Desroches J, Ruel M, Beaulieu P. Efficacy of a propofol bolus against placebo to prevent cough at emergence from general anesthesia with desflurane: a randomized controlled trial. Can J Anaesth. 2023 May;70(5):842-850. doi: 10.1007/s12630-023-02401-w. Epub 2023 Feb 24.
PubMed 36829104
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intravenous Dose of Propofol Versus Placebo in the Prevention of Coughing During Emergence of General Anesthesia Under Desflurane
- ClinicalTrials.gov ID
- NCT02932397
- Acronym / sponsor ID
- PROPOREV / CE16.176
- Conditions
- Elective Surgery, Coughing
- Keywords
- Ambulatory surgery, Perioperative outcomes, General anesthesia under desflurane, Prevention of coughing, Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Intravenous dose of 0.5 mg/kg of propofolActive drug given to patients as an intravenous dose of 0.5 mg/kg of propofol |
| Saline solution | Placebo comparator | Drug: Intravenous dose of 0.05 mL/kg of saline solutionPlacebo drug given to patients as an intravenous dose of 0.05 mL/kg of saline solution (NaCl 0.9%) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous dose of 0.5 mg/kg of propofol | Drug | Propofol |
| Intravenous dose of 0.05 mL/kg of saline solution | Drug | Saline solution |
Primary outcome
Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane)
Time frame: one day, perioperative period
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
11 secondary outcomes
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)
Time frame: one day, perioperative period
Extubation time
Time frame: one day, perioperative period
Sedation of the patient
Time frame: one day, perioperative period
Incidence of hypoventilation
Time frame: one day, perioperative period
Incidence of hypoxic episode
Time frame: one day, perioperative period
Blood pressure
Time frame: one day, perioperative period
Heart rate
Time frame: one day, perioperative period
Agitation of the patient during emergence
Time frame: one day, perioperative period
Complications
Time frame: one day, perioperative period
Cumulative incidence of nausea/vomiting
Time frame: one day, perioperative period
Swallowing pain scores
Time frame: one day, perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Derived from this study: PubMed 36829104Ouellet MF, Moore A, Williams S, Girard F, Desroches J, Ruel M, Beaulieu P. Efficacy of a propofol bolus against placebo to prevent cough at emergence from general anesthesia with desflurane: a randomized controlled trial. Can J Anaesth. 2023 May;70(5):842-850. doi: 10.1007/s12630-023-02401-w. Epub 2023 Feb 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Beaulieu, MD, PhD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous dose of 0.5 mg/kg of propofol and Intravenous dose of 0.05 mL/kg of saline solution in people with Elective Surgery and Coughing, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane) (time frame: one day, perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.