Ambulatory Surgery, Coughing
Conditions
Keywords
Ambulatory surgery, Pain management, Perioperative outcomes, Fentanyl, Coughing during insertion of an LMA, Ambulatory surgery procedures
Brief summary
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.
Detailed description
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.
Interventions
DRUGSaline
2 ml at induction 1-2 ml boluses as needed
DRUGFentanyl
Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo outpatient arthroscopic surgery procedures * Willingness and ability to sign an informed consent document * No allergies to anesthetic or analgesic medications * 18 - 80 years of age * American Society of Anesthesiologists (ASA) Class I - III adults of either sex * Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test
Exclusion criteria
* Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications * Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders * Pregnant or lactating women * Subjects with a history of alcohol or drug abuse within the past 3 months * Any other conditions or use of any medication which may interfere with the conduct of the study (e.g., asthmatic patients history of asthma, chronic cough, or upper respiratory tract infection during the previous 2 wk or recent treatment with angiotensin-converting enzyme inhibitors, bronchodilators, or steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Coughing | one day | during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Nausea and Vomiting | 1 day | Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit. |
| Postoperative Pain | one day | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Fentanyl | Saline Solution | Total |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 14 | 48 years STANDARD_DEVIATION 16 | 48 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 23 Participants | 27 Participants | 50 Participants |
| Sex: Female, Male Male | 27 Participants | 23 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: one day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl | Incidence of Coughing | 10 participants |
| Saline Solution | Incidence of Coughing | 6 participants |
Secondary
Incidence of Nausea and Vomiting
Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl | Incidence of Nausea and Vomiting | 2 participants |
| Saline Solution | Incidence of Nausea and Vomiting | 4 participants |
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.
Time frame: one day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fentanyl | Postoperative Pain | 1.5 Scores on a scale | Standard Deviation 1.8 |
| Saline Solution | Postoperative Pain | 1.5 Scores on a scale | Standard Deviation 1.6 |