Back to resultsDoes Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia
Primary Purpose
Cough
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Remifentanil
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Cough focused on measuring extubation
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 18 and 80
- ASA of 1-3
Undergoing any of the following elective cases:
- thyroidectomy (partial or complete)
- parathyroidectomy
- ophthalmological surgery
- Will require endotracheal intubation.
Exclusion Criteria:
- Lean Body Mass < 20 kg,
- BMI > 45
- Presence of pulmonary dysfunction
- Any history of anaphylaxis to remifentanil
- Requiring the use of total intravenous anesthesia.
- Per the discretion of the anesthesia provider
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Remifentanil group
Control group
Arm Description
Will receive remifentanil bolus and infusion guided by an algorithm
Will receive normal saline bolus and infusion guided by the remifentanil algorithm
Outcomes
Primary Outcome Measures
Incidence of cough
Notes presence of cough during emergence
Secondary Outcome Measures
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.
Extubation time
Time between the termination of the anesthetic and extubation
Time to recovery
Time between extubation and the ability to perform purposeful movement
Full Information
NCT ID
NCT03783676
First Posted
December 15, 2018
Last Updated
December 20, 2018
Sponsor
University of Vermont Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03783676
Brief Title
Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia
Official Title
Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2019 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
extubation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil group
Arm Type
Experimental
Arm Description
Will receive remifentanil bolus and infusion guided by an algorithm
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Will receive normal saline bolus and infusion guided by the remifentanil algorithm
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Receive remifentanil bolus and infusion guided by an algorithm.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Receive normal saline bolus and infusion guided by the remifentanil algorithm.
Primary Outcome Measure Information:
Title
Incidence of cough
Description
Notes presence of cough during emergence
Time Frame
Measured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutes
Secondary Outcome Measure Information:
Title
Coughing grade
Description
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.
Time Frame
Measured from surgical end time to patient transfer out of room, approximetly 30 minutes
Title
Extubation time
Description
Time between the termination of the anesthetic and extubation
Time Frame
Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes
Title
Time to recovery
Description
Time between extubation and the ability to perform purposeful movement
Time Frame
Measured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18 and 80
ASA of 1-3
Undergoing any of the following elective cases:
thyroidectomy (partial or complete)
parathyroidectomy
ophthalmological surgery
Will require endotracheal intubation.
Exclusion Criteria:
Lean Body Mass < 20 kg,
BMI > 45
Presence of pulmonary dysfunction
Any history of anaphylaxis to remifentanil
Requiring the use of total intravenous anesthesia.
Per the discretion of the anesthesia provider
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elie Sarraf, MD.CM.
Phone
(802) 847-4259
Email
elie.sarraf@uvmhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alex F Friend
Phone
(802) 847-4259
Email
Alexander.Friend@uvmhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie Sarraf, MD.CM.
Organizational Affiliation
Resident
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia
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