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The purpose of this research is to evaluate the effectiveness of fentanyl for reducing coughing during the perioperative period (i.e., insertion of an LMA [Laryngeal Mask Airway] device, maintenance period during surgery, and awakening [emergence] from general anesthesia) for ambulatory surgery procedures. Also to assess the effects of fentanyl on the postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel function [constipation], resumption of normal activities of daily living).
Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because of its anesthetic-sparing effects and alleged ability to reduce coughing during instrumentation of the patient's airway.
This research study is designed to evaluate the effects of fentanyl when administered as an adjuvant to standard anesthetic and analgesic drugs on coughing (during insertion of an LMA device, during maintenance and emergence from general anesthesia) and on the postoperative adverse outcomes (i.e., side effects).
All patients will receive local anesthetics and commonly used non-opioid pain relieving medications during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Active Comparator | Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed |
|
| Saline Solution | Placebo Comparator | Saline Solution 2 ml at induction, 1-2 ml boluses as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | 2 ml at induction 1-2 ml boluses as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Coughing | during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures. | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Nausea and Vomiting | Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit. | 1 day |
| Postoperative Pain | Postoperative pain measured using a Verbal Rating Scale (VRS) at post-anesthesia care unit (PACU), (90 minutes after arriving). Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ronald H Wender, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25329822 | Derived | White PF, Elvir-Lazo OL, Zaentz AS, Kariger R, Yumul R, Khany MM, Stern A, Vuong M, Wender RH. Does small-dose fentanyl improve perioperative outcomes in the ambulatory setting? A randomized, double-blind, placebo-controlled study. Acta Anaesthesiol Scand. 2015 Jan;59(1):56-64. doi: 10.1111/aas.12424. Epub 2014 Oct 20. |
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Prior to the day of surgery, potential study patients scheduled to undergo superficial surgical procedures received a packet of materials from their surgeon. The packet contained an initial patient contact letter, a privacy information sheet, and the institution review board (IRB)-approved informed consent form.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl | Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed |
| FG001 | Saline Solution | Saline Solution 2 ml at induction, 1-2 ml boluses as needed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl | Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed Saline: 2 ml at induction 1-2 ml boluses as needed |
| BG001 | Saline Solution | Saline Solution 2 ml at induction, 1-2 ml boluses as needed Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Coughing | during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures. | Posted | Number | participants | one day |
|
No adverse event reported during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fentanyl | Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed Saline: 2 ml at induction 1-2 ml boluses as needed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul F White | Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles | 214-7703775 | paul.white@cshs.org |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Fentanyl | Drug | Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed |
|
| one day |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Incidence of Nausea and Vomiting | Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit. | Posted | Number | participants | 1 day |
|
|
|
| Secondary | Postoperative Pain | Postoperative pain measured using a Verbal Rating Scale (VRS) at post-anesthesia care unit (PACU), (90 minutes after arriving). Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain. | Posted | Mean | Standard Deviation | Scores on a scale | one day |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Saline Solution | Saline Solution 2 ml at induction, 1-2 ml boluses as needed Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed | 0 | 50 | 0 | 50 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D017670 |
| Sodium Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |