Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

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.

Study Overview

• Status: Unknown
• Conditions: Cough
• Intervention / Treatment: Drug: Remifentanil; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remifentanil group; Will receive remifentanil bolus and infusion guided by an algorithm	Drug: Remifentanil; Receive remifentanil bolus and infusion guided by an algorithm.
Placebo Comparator: Control group; Will receive normal saline bolus and infusion guided by the remifentanil algorithm	Drug: Normal saline; Receive normal saline bolus and infusion guided by the remifentanil algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center
• Investigators: Principal Investigator: Elie Sarraf, MD.CM., Resident

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2019
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 15, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: extubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 18-0415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes