Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

Cough Clinical Trial

Official title:

Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03783676
• Other study ID #: 18-0415
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 15, 2019
• Est. completion date: June 2019

Study information

• Verified date: December 2018
• Source: University of Vermont Medical Center
• Contact: Elie Sarraf, MD.CM.
• Phone: (802) 847-4259
• Email: elie.sarraf[@]uvmhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to find a way to reduce or stop patients from coughing at the end of surgery when the breathing tube is taken out. The breathing tube is removed when the participants are waking up from anesthesia, and are at the point when the participants can breathe on your own. In most types of surgery, coughing at this point is common, and does not affect the participants very much, if at all. But for surgery involving the eye or the head and neck, coughing right after surgery can cause bleeding at the site of surgery.

This study will use a short-acting pain drug called remifentanil at the end of surgery to prevent coughing. The investigators will give the participants this medicine for 5 to 30 minutes. The point of the study is to test if using a simple computer program to guide precise delivery of how much of the drug is given to the participants is effective at reducing or preventing coughing.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Between the ages of 18 and 80

2. ASA of 1-3

3. Undergoing any of the following elective cases:

1. thyroidectomy (partial or complete)

2. parathyroidectomy

3. ophthalmological surgery

4. Will require endotracheal intubation.

Exclusion Criteria:

1. Lean Body Mass < 20 kg,

2. BMI > 45

3. Presence of pulmonary dysfunction

4. Any history of anaphylaxis to remifentanil

5. Requiring the use of total intravenous anesthesia.

6. Per the discretion of the anesthesia provider

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Remifentanil
Receive remifentanil bolus and infusion guided by an algorithm.
• Normal saline
Receive normal saline bolus and infusion guided by the remifentanil algorithm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cough	Notes presence of cough during emergence	Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutes
Secondary	Coughing grade	Ranks severity of cough during emergence: cough was graded according to the following scoring guidelines: 0=no cough, 1=slight cough, cough without obvious contraction of the abdomen, 2=moderate cough, strong and sudden contraction of the abdomen lasting for less than 5 seconds and 3=severe cough, strong and sudden contraction of the abdomen sustained for more than 5 seconds.	Measured from surgical end time to patient transfer out of room, approximetly 30 minutes
Secondary	Extubation time	Time between the termination of the anesthetic and extubation	Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes
Secondary	Time to recovery	Time between extubation and the ability to perform purposeful movement	Measured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutes