Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

NCT03783676 | Unknown Phase 4 FDA Drug

• 1 other identifier: 18-0415
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cough

Keywords

extubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Coughing grade

  Measured from surgical end time to patient transfer out of room, approximetly 30 minutes

• Extubation time

  Measured from termination of the anesthetic to extubation, approximetly 5 minutes and up to 30 minutes

• Time to recovery

  Measured from extubation to purposeful movement, approximetly 5 minutes and up to 30 minutes

Study Arms (2)

Remifentanil group

EXPERIMENTAL

Will receive remifentanil bolus and infusion guided by an algorithm

Drug: Remifentanil

Control group

PLACEBO COMPARATOR

Will receive normal saline bolus and infusion guided by the remifentanil algorithm

Drug: Normal saline

Interventions

Remifentanil DRUG

Receive remifentanil bolus and infusion guided by an algorithm.

Remifentanil group

Normal saline DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead

MeSH Terms

Conditions

Cough

Interventions

Remifentanil; Saline Solution

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Elie Sarraf, MD.CM.

  Resident

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elie Sarraf, MD.CM.

CONTACT

(802) 847-4259; elie.sarraf@uvmhealth.org

Alex F Friend

CONTACT

(802) 847-4259; Alexander.Friend@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 21, 2018
• Study Start: February 15, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 24, 2018

Record last verified: 2018-12