Trial Outcomes & Findings for Esmolol Infusion During Laminectomy: Effect on Quality of Recovery (NCT NCT01179113)

Results Overview

Verbal Rating Scale goes from 0 to 10, where: 0 indicates= No pain" and 10 indicates= The worst possible pain The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

1 day

Results posted on

2016-11-02

Participant Flow

Prior to the day of surgery, potential study patients scheduled to undergo spine 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	Placebo A normal saline bolus during induction, and an infusion of normal saline intraoperatively.	Esmolol Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Overall Study STARTED	17	16
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Esmolol Infusion During Laminectomy: Effect on Quality of Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=17 Participants A normal saline bolus during induction, and an infusion of normal saline intraoperatively.	Esmolol n=16 Participants Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively	Total n=33 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 11 • n=5 Participants	54 years STANDARD_DEVIATION 16 • n=7 Participants	57 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Body Mass Index (BMI)	26 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	26 kg/m^2 STANDARD_DEVIATION 4 • n=7 Participants	26 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Verbal Rating Scale goes from 0 to 10, where: 0 indicates= No pain" and 10 indicates= The worst possible pain The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants A normal saline bolus during induction, and an infusion of normal saline intraoperatively.	Esmolol n=16 Participants Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Post-operative Pain Using Verbal Rating Scale (VRS)	4 Scores on a scale Standard Deviation 4	5 Scores on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: 1 day

Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts).

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants A normal saline bolus during induction, and an infusion of normal saline intraoperatively.	Esmolol n=16 Participants Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Opioid Consumption in PACU Obtained From the Recorded Data	1.5 mg Standard Deviation 0.6	2 mg Standard Deviation 2.6

SECONDARY outcome

Timeframe: 1 day

Number of participants that experienced Postoperative nausea and vomiting using at PACU

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants A normal saline bolus during induction, and an infusion of normal saline intraoperatively.	Esmolol n=16 Participants Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
Postoperative Nausea and Vomiting	2 participants	0 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Esmolol

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

Dr. Roya Yumu', Anesthesiology Program Director

Cedars Sinai Medical Center

Phone: 310-423-1682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place