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

Not Applicable

Completed

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

• Registration Number: NCT02932397
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Intravenous dose of 0.5 mg/kg of propofol	Active drug given to patients as an intravenous dose of 0.5 mg/kg of propofol
Saline solution	Intravenous dose of 0.05 mL/kg of saline solution	Placebo drug given to patients as an intravenous dose of 0.05 mL/kg of saline solution (NaCl 0.9%)

Primary Outcome Measures

Name	Time	Method
Incidence of coughing (between discontinuation of desflurane and minimum alveolar concentration (MAC) of 0.15 of desflurane)	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 Outcome Measures

Name	Time	Method
Incidence of hypoventilation	one day, perioperative period	incidence of hypoventilation (breathing rate \< 8/min)
Incidence of hypoxic episode	one day, perioperative period	incidence of hypoxic episode (oxygen saturation \< 90%)
Blood pressure	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
Heart rate	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
Agitation of the patient during emergence	one day, perioperative period	Note the possible agitation of the patient during emergence
Complications	one day, perioperative period	Describe potential complications secondary to the bolus of the substance under study at the emergence
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)	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
Extubation time	one day, perioperative period	Interval between discontinuation of desflurane and extubation
Sedation of the patient	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
Cumulative incidence of nausea/vomiting	one day, perioperative period	Calculate cumulative incidence of nausea/vomiting between extubation and 30 minutes after the admission in the recovery room
Swallowing pain scores	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

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montreal, Quebec, Canada