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Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03783676
Enrollment
60
Registered
2018-12-21
Start date
2019-02-15
Completion date
2019-06-30
Last updated
2018-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Keywords

extubation

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.

Interventions

DRUGRemifentanil

Receive remifentanil bolus and infusion guided by an algorithm.

DRUGNormal saline

Receive normal saline bolus and infusion guided by the remifentanil algorithm.

Sponsors

University of Vermont Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of coughMeasured from surgical end time to patient transfer out of room, approximetly 30 minutes and up to 45 minutesNotes presence of cough during emergence

Secondary

MeasureTime frameDescription
Coughing gradeMeasured from surgical end time to patient transfer out of room, approximetly 30 minutesRanks 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 timeMeasured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutesTime between the termination of the anesthetic and extubation
Time to recoveryMeasured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutesTime between extubation and the ability to perform purposeful movement

Contacts

Primary ContactElie Sarraf, MD.CM.
elie.sarraf@uvmhealth.org(802) 847-4259
Backup ContactAlex F Friend
Alexander.Friend@uvmhealth.org(802) 847-4259

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026