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

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Overall Status: Completed
• CT.gov ID: NCT01489072
• Collaborator: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (Other)
• Enrollment: 180
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 29.9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Cough; Anesthesia	Drug: Remifentanil; Drug: Remifentanil	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparison of the Efficacy of Two Bolus Doses of Remifentanil on the Incidence of Coughing During Emergence of Anesthesia.
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remifentanil 0.25 mcg/kg Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia	Drug: Remifentanil; Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia
Active Comparator: Remifentanil 0.5 mcg/kg Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia	Drug: Remifentanil; Bolus dose of intravenous remifentanil 0.5 mcg/kg given once before emergence of general anesthesia

Outcome Measures

Primary Outcome Measures

1. Incidence of coughing during emergence and the first ten minutes after extubation [From emergence until 10 minutes after extubation]

Secondary Outcome Measures

1. Time elapsed between the bolus dose of remifentanil and extubation [Assessed at emergence of general anesthesia]

2. Incidence of sore throat one hour after extubation [Assessed one hour after extubation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame	Montreal	Quebec	Canada	H2L 4M1

Sponsors and Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Investigators

• Principal Investigator: Nathalie Massicotte, MD, FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• ClinicalTrials.gov Identifier: NCT01489072
• Other Study ID Numbers: NM 2012-002
• First Posted: Dec 9, 2011
• Last Update Posted: Oct 29, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Cough; Remifentanil

Study Results

No Results Posted as of Oct 29, 2012