Trial Outcomes & Findings for The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery (NCT NCT01782898)

Last Updated: 2016-11-11

Results Overview

Quality of recovery questionnaire score at 24 hours after surgery. Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery. Time frame for this evaluation is 24 hours after the surgical procedure

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

24 hours

Results posted on

2016-11-11

Participant Flow

Participant milestones

Participant milestones
Measure	Esmolol Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min	.9 Normal Saline .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Overall Study STARTED	35	35
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Intraoperative Esmolol to Improve Postoperative Quality of Recovery and Pain After Ambulatory Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esmolol n=29 Participants Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min	.9 Normal Saline n=29 Participants .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38 Years n=5 Participants	41 Years n=7 Participants	39 Years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants
BMI (kg/m^2)	23 (kg/m^2) n=5 Participants	24 (kg/m^2) n=7 Participants	24 (kg/m^2) n=5 Participants
Intraoperative Fentanyl (mcg)	100 micrograms n=5 Participants	100 micrograms n=7 Participants	100 micrograms n=5 Participants
Surgical Duration	82 Minutes n=5 Participants	72 Minutes n=7 Participants	77 Minutes n=5 Participants
American Society of Anesthesiologist Classification ASA Class 1	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants
American Society of Anesthesiologist Classification ASA Class 2	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Esmolol n=29 Participants Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min	.9 Normal Saline n=29 Participants .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Qor-40 at 24 Hours Postoperative	179 units on a scale 40 low-200 high Interval 171.0 to 190.0	182 units on a scale 40 low-200 high Interval 173.0 to 189.0

SECONDARY outcome

Timeframe: 24 hours

The total amount of opioid consumed by subject at 24 hours after surgery measured in IV morphine equivalents.

Outcome measures

Outcome measures
Measure	Esmolol n=29 Participants Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min	.9 Normal Saline n=29 Participants .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Postoperative Opioid Consumption	2.5 IV mg of morpine equivalents Interval 0.0 to 6.0	0 IV mg of morpine equivalents Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 24 hour

Post operative pain reported by the subject as determined as area under the numeric rating scale for pain versus time curve in the post anesthesia care unit ( score\*min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score \* min). A higher value indicates more pain over 24 hours.The range is 0 pain to x time in minutes x hour ( 60-1440 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU to 24 hours after the surgical procedure. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.

Outcome measures

Outcome measures
Measure	Esmolol n=29 Participants Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min	.9 Normal Saline n=29 Participants .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Post Operative Pain Reported by the Subject.	218 (pain score * minutes ) in the PAC U Interval 90.0 to 270.0	150 (pain score * minutes ) in the PAC U Interval 45.0 to 240.0

Adverse Events

Esmolol

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

.9 Normal Saline

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Esmolol n=29 participants at risk Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min	.9 Normal Saline n=29 participants at risk .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered, Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
Gastrointestinal disorders Nausea	31.0% 9/29 • Number of events 9	34.5% 10/29 • Number of events 10
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 1	0.00% 0/29

Additional Information

Gildasio De Oliveira, M.D.

Northwestern University

Phone: 312-695-4858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place