Efficacy of Alkalinized Lidocaine Compared to Remifentanil on the Incidence of Coughing During Emergence of Anesthesia

Anesthesia Clinical Trial

Official title:

Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff Compared to a Bolus Dose of Intravenous Remifentanil on the Incidence of Coughing During Emergence of Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451840
• Other study ID #: NM2012-001
• Status: Completed
• Phase: N/A
• First received: October 11, 2011
• Last updated: October 25, 2012
• Start date: January 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 alkalinized lidocaine in the endotracheal tube cuff to a bolus dose of 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 alkalinized lidocaine in the endotracheal tube cuff will reduce the incidence of perioperative coughing after a desflurane-based anesthesia.

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.

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. Different techniques and drugs have been studied to reduce coughing during emergence.

Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. The use of intracuff alkalinized lidocaine has been proven effective to reduce the incidence of coughing during emergence of anesthesia.

Furthermore, there is some evidence supporting the administration of intravenous opioids prior to emergence of general anesthesia to reduce perioperative coughing, agitation and hemodynamic 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. Bolus doses of remifentanil have also been proven effective to reduce the hemodynamic response to extubation.

The effect of these two modalities (alkalinized lidocaine and remifentanil) have never been compared. This study will assess their efficacy to prevent perioperative coughing after a desflurane-based anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• 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 oral endotracheal intubation (excluding head and neck surgery)

• Expected duration of surgery of at least 1.5 hour.

Exclusion Criteria:

• Current use of ACE inhibitor

• 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, lidocaine

• 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
• Alkalinized lidocaine
Administration of alkalinized lidocaine in the endotracheal tube cuff

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	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 after extubation		From emergence until 10 minutes after extubation	Yes
Secondary	Time to emergence		From the discontinuation of Desflurane until extubation	Yes
Secondary	Incidence of sore throat one hour after extubation		Assessed one hour after extubation	Yes