Trial Outcomes & Findings for Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management (NCT NCT01368809)

Results Overview

during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

one day

Results posted on

2016-04-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Fentanyl Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed	Saline Solution Saline Solution 2 ml at induction, 1-2 ml boluses as needed
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fentanyl n=50 Participants 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	Saline Solution n=50 Participants 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	Total n=100 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 14 • n=93 Participants	48 years STANDARD_DEVIATION 16 • n=4 Participants	48 years STANDARD_DEVIATION 15 • n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	27 Participants n=4 Participants	50 Participants n=27 Participants
Sex: Female, Male Male	27 Participants n=93 Participants	23 Participants n=4 Participants	50 Participants n=27 Participants
Region of Enrollment United States	50 participants n=93 Participants	50 participants n=4 Participants	100 participants n=27 Participants

PRIMARY outcome

Timeframe: one day

during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.

Outcome measures

Outcome measures
Measure	Fentanyl n=50 Participants 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	Saline Solution n=50 Participants 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
Incidence of Coughing	10 participants	6 participants

SECONDARY outcome

Timeframe: 1 day

Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.

Outcome measures

Outcome measures
Measure	Fentanyl n=50 Participants 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	Saline Solution n=50 Participants 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
Incidence of Nausea and Vomiting	2 participants	4 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Fentanyl n=50 Participants 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	Saline Solution n=50 Participants 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
Postoperative Pain	1.5 Scores on a scale Standard Deviation 1.8	1.5 Scores on a scale Standard Deviation 1.6

Adverse Events

Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul F White

Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles

Phone: 214-7703775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place