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

NCT02932397 | Completed DMC

• 1 other identifier: CE16.176
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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).

Conditions

Elective Surgery; Coughing

Keywords

Ambulatory surgery; Perioperative outcomes; General anesthesia under desflurane; Prevention of coughing; Propofol

Outcome Measures

Primary Outcomes (1)

• 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 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)

  one day, perioperative period

• Extubation time

  one day, perioperative period

• Sedation of the patient

  one day, perioperative period

• Incidence of hypoventilation

  one day, perioperative period

• Incidence of hypoxic episode

  one day, perioperative period

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Saline solution

PLACEBO COMPARATOR

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

Interventions

Intravenous dose of 0.5 mg/kg of propofol DRUG

Propofol

Intravenous dose of 0.05 mL/kg of saline solution DRUG

Saline solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM

Montreal, Quebec, H2W 1T8, Canada

Location

Related Publications (1)

• 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.

  PMID: 36829104 DERIVED

MeSH Terms

Conditions

Cough

Interventions

Propofol; Saline Solution

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pierre Beaulieu, MD, PhD

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 13, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)