Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia

Anesthesia Clinical Trial

Official title:

Comparison of the Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489072
• Other study ID #: NM 2012-002
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: October 25, 2012
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the effects of two bolus doses of intravenous remifentanil given prior to the emergence of anesthesia:

• on the incidence of perioperative coughing

• on the time needed for the emergence of a desflurane-based anesthesia

• on the incidence of sore throat after extubation.

The investigators hypothesis is that the use of a higher remifentanil bolus dose (0.5 mcg/kg) given prior to emergence of a desflurane-based anesthesia will reduce the incidence of perioperative coughing when compared to a lower dose of remifentanil (0.25 mcg/kg).

Description:

Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.

Most patients will cough during emergence. Different techniques and drugs have been studied to reduce coughing during emergence.

There is some evidence supporting the administration of intravenous opioids prior to emergence of general anesthesia to reduce perioperative coughing, agitation and haemodynamic stimulation. However, depending on the type of opioids given, this may delay the emergence from anesthesia. The effect of a remifentanil infusion given in combination with isoflurane as the volatile agent has been shown to reduce the incidence of perioperative coughing without delaying the emergence of anesthesia. The effect of a small bolus of remifentanil given prior to emergence to prevent perioperative coughing has yet to be studied.

Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia.

This study will compare the effects of two bolus doses of remifentanil (0.25 mcg/kg to 0.5 mcg/kg) when given prior to emergence to prevent perioperative coughing after a desflurane-based anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-80 years

• Physical status 1-3

• Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (excluding head and neck surgery)

Exclusion Criteria:

• Current use of ACE inhibitors

• Chronic cough

• Asthma or severe pulmonary disease

• Pulmonary tract infection

• Anticipated difficult intubation

• Current use of opioids

• Current use of cough medicine

• Contraindication to remifentanil

• Pregnancy

• Symptomatic cardiac, renal or hepatic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia
• Cough

Intervention

Drug:
• Remifentanil
Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia
• Remifentanil
Bolus dose of intravenous remifentanil 0.5 mcg/kg given once before emergence of general anesthesia

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of coughing during emergence and the first ten minutes after extubation		From emergence until 10 minutes after extubation	Yes
Secondary	Time elapsed between the bolus dose of remifentanil and extubation		Assessed at emergence of general anesthesia	Yes
Secondary	Incidence of sore throat one hour after extubation		Assessed one hour after extubation	Yes