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Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

U

University of Vermont Medical Center

Status and phase

Unknown
Phase 4

Conditions

Cough

Treatments

Drug: Normal saline
Drug: Remifentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT03783676
18-0415

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Remifentanil group
Experimental group
Description:
Will receive remifentanil bolus and infusion guided by an algorithm
Treatment:
Drug: Remifentanil
Control group
Placebo Comparator group
Description:
Will receive normal saline bolus and infusion guided by the remifentanil algorithm
Treatment:
Drug: Normal saline

Trial documents
2

Trial contacts and locations

0

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Central trial contact

Alex F Friend; Elie Sarraf, MD.CM.

Data sourced from clinicaltrials.gov

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