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

NCT ID: NCT02932397

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Propofol

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

Group Type: ACTIVE_COMPARATOR

Intravenous dose of 0.5 mg/kg of propofol

Intervention Type: DRUG

Saline solution

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

Group Type: PLACEBO_COMPARATOR

Intravenous dose of 0.05 mL/kg of saline solution

Intervention Type: DRUG

Interventions

Intravenous dose of 0.5 mg/kg of propofol

Intervention Type: DRUG

Intravenous dose of 0.05 mL/kg of saline solution

Intervention Type: DRUG

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Beaulieu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

CHUM

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36829104 (View on PubMed)

Other Identifiers

CE16.176

Identifier Type: -

Identifier Source: org_study_id