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NCT Number: NCT02932397

Efficacy of Propofol vs 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).

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Key information

Conditions

Elective Surgery Cough Coughing Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUM

Montreal, Quebec, H2W 1T8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous dose of 0.5 mg/kg of propofol

Drug

Intravenous dose of 0.05 mL/kg of saline solution

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. Extubation time

    Time frame: one day, perioperative period

    Interval between discontinuation of desflurane and extubation

  3. Sedation of the patient

    Time frame: one day, perioperative period

    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

  4. Incidence of hypoventilation

    Time frame: one day, perioperative period

    incidence of hypoventilation (breathing rate < 8/min)

  5. Incidence of hypoxic episode

    Time frame: one day, perioperative period

    incidence of hypoxic episode (oxygen saturation < 90%)

  6. Blood pressure

    Time frame: one day, perioperative period

    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

  7. Heart rate

    Time frame: one day, perioperative period

    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

  8. Agitation of the patient during emergence

    Time frame: one day, perioperative period

    Note the possible agitation of the patient during emergence

  9. Complications

    Time frame: one day, perioperative period

    Describe potential complications secondary to the bolus of the substance under study at the emergence

  10. Cumulative incidence of nausea/vomiting

    Time frame: one day, perioperative period

    Calculate cumulative incidence of nausea/vomiting between extubation and 30 minutes after the admission in the recovery room

  11. Swallowing pain scores

    Time frame: one day, perioperative period

    Evaluate swallowing pain scores evaluated using a verbal simple numeric scale (0 = no pain et 10 = worst pain imaginable) 30 min after extubation

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Acronym: PROPOREV

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2016
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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