Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

Phase 4

• Conditions: Cough
• Interventions: Drug: Normal saline; Drug: Remifentanil

• Registration Number: NCT03783676
• Lead Sponsor: University of Vermont Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-15
• Study First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Study First Posted: 2018-12-21
• Last Update Posted: 2018-12-24
• Study Start: 2019-02-15
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Normal saline	Will receive normal saline bolus and infusion guided by the remifentanil algorithm
Remifentanil group	Remifentanil	Will receive remifentanil bolus and infusion guided by an algorithm

Primary Outcome Measures

Name	Time	Method
Incidence of cough	Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutes	Notes presence of cough during emergence

Secondary Outcome Measures

Name	Time	Method
Coughing grade	Measured from surgical end time to patient transfer out of room, approximetly 30 minutes	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.
Extubation time	Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes	Time between the termination of the anesthetic and extubation
Time to recovery	Measured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutes	Time between extubation and the ability to perform purposeful movement