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Does Precise Delivery of Remifentanil Decrease Coughing at Emergence From Anesthesia

NCT ID: NCT03783676

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cough

Keywords

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extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Remifentanil group

Will receive remifentanil bolus and infusion guided by an algorithm

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Receive remifentanil bolus and infusion guided by an algorithm.

Control group

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Remifentanil

Receive remifentanil bolus and infusion guided by an algorithm.

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vermont Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Elie Sarraf

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elie Sarraf, MD.CM.

Role: PRINCIPAL_INVESTIGATOR

Resident

Central Contacts

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Elie Sarraf, MD.CM.

Role: CONTACT

Phone: (802) 847-4259

Email: [email protected]

Alex F Friend

Role: CONTACT

Phone: (802) 847-4259

Email: [email protected]

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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18-0415

Identifier Type: -

Identifier Source: org_study_id