Labetalol and Esmolol: Vital Signs and Post Operative Pai... | NCT01114971

Labetalol and Esmolol: Vital Signs and Post Operative Pai... | NCT01114971 | Trialant

Description Module

Detailed Description

Finding the optimal combination of anesthetic adjuvant drugs for maintaining hemodynamic stability during surgery is a challenge (1-3). Traditionally, potent opioid analgesics like fentanyl and its newer analogs have been used for this purpose. However, use of opioid compounds is associated with well-known side effects (e.g., ventilatory depression, postoperative nausea and vomiting, constipation, ileus, bladder dysfunction, urinary retention, pruritus, drowsiness and sedation). All of these common side effects interfere with the early recovery process and contribute to a delayed resumption of normal activities (4, 5). Increasingly, non-opioid analgesics (e.g. β-blockers and local anesthetics) are being utilized as adjuvant drugs during surgery for treatment of acute hyperdynamic responses (increased catecholamine release) during surgery, as well as, facilitation of the recovery process after surgery because of their anesthetic and analgesic-sparing effects. The β-blocking drugs, esmolol and labetalol have been used as an alternative to short-acting opioid analgesics for controlling the transient, acute autonomic responses during surgery (5-8), They have been shown to reduce the anesthetic requirement during intravenous (propofol) or volatile-based anesthesia (6,7,10-13) and to decrease opioid consumption intraoperatively and in the PACU (8). They may also improve hemodynamic stability during induction and emergence from anesthesia in the perioperative and early postoperative period and facilitate the resumption of normal activities after major surgical procedures. The anesthetic and analgesic-sparing effects of β -blockers also lead to a faster emergence from anesthesia and reduce postoperative opioid side effects (e.g., PONV) (14-18). Perioperative intravenous esmolol has shown improvement in perioperative outcomes, decreases acute hemodynamic responses, reduces anesthetics and opioids use during anesthesia, facilitates a faster emergence from anesthesia, reduces intraoperative and postoperative opioid requirements, reduces side effects as such as pruritus, constipation, ileus, nausea and vomiting (PONV) and thereby shortens the hospital stay. (3, 7, 13, 18)

Local anesthetics like lidocaine possess analgesic, antihyperalgesic and anti-inflammatory properties. Perioperative intravenous lidocaine has shown improvement in perioperative outcomes in patients undergoing abdominal surgery to decrease intraoperative requirement of Inhalants/Intravenous agents, opioid consumption, postoperative pain, fatigue, nausea and vomiting scores, maintain hemodynamic stability, facilitate a more rapid recovery of gastrointestinal function, improve postoperative recovery, fast resumption of normal activities of daily living and shorten length of hospital stay, when administered as an adjuvant during surgery.(19,23-29,33)

Theoretically, it would be extremely beneficial to administer an adjuvant (to patients undergoing abdominal surgery) that is capable of effectively controlling autonomic responses during surgery, while providing a faster recovery with fewer side effects. Preliminary data suggests that the perioperative effects of systemic administration of lidocaine and esmolol is most effective in facilitating bowel recovery, decreasing opioid consumption in the intra/postoperative period, and shorten length of hospital stay with early recovery. Therefore, we designed this prospective, randomized, double-blinded, active-controlled study to test the hypothesis that systemic administration of lidocaine and esmolol in combination (vs. either drug alone) for maintenance of hemodynamic stability during surgery will result in improved postoperative outcomes for patients undergoing abdominal surgery (e.g., less pain and postoperative nausea and vomiting, and faster return of bowel function and resumption of normal activities of daily living); leading to a shorten length of hospital stay.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fentanyl	Active Comparator	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm)	Drug: Labetalol Drug: Esmolol
Labetalol	Experimental	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Drug: Fentanyl Drug: Esmolol
Esmolol	Experimental	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)	Drug: Fentanyl Drug: Labetalol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl	Drug	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Pain	Postoperative pain will be measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 VRS is a subjective measure in which individuals verbally rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)	one day

Secondary Outcomes

Measure	Description	Time Frame
Number of Participant With Opioid Consumption	n=Post discharge use of opioid consumption NUMBER OF PARTICIPANTS WHO TOOK PAIN KILLER PILLS	1 month
Postoperative Nausea and Vomiting	Nausea and vomiting will be measured at PACU

Contacts/Locations Module

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

Arm/Group Information

ID	Title	Description
FG000	Fentanyl	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
FG001	Labetalol	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
FG002	Esmolol	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00025 subjects FG00125 subjects FG00225 subjects
COMPLETED		FG00025 subjects FG00125 subjects FG00225 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Fentanyl	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Postoperative Pain

Postoperative pain will be measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 VRS is a subjective measure in which individuals verbally rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)

Posted

Mean

Standard Deviation

Score on scale 0-10

one day

ID	Title	Description
OG000	Fentanyl	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Adverse Events Module

Arm/Groups

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 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Proffesor Paul F. White	Cedars Sinai Medical Center	2147703775		paul.white@cshs.org

Condition Browse Module

ID	Term
D000377	Agnosia

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Intervention Browse Module

ID	Term
D005283	Fentanyl
D007741	Labetalol
C036604	esmolol

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D004983	Ethanolamines

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020 BG0030
Asian	BG0003 BG0010 BG0021 BG0034
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020 BG0030
Black or African American	BG0003 BG0016 BG0024 BG00313
White	BG00019 BG00119 BG00219 BG00357
More than one race	BG0000 BG0010 BG0021 BG0031
Unknown or Not Reported	BG0000 BG0010 BG0020 BG0030

Secondary

Number of Participant With Opioid Consumption

n=Post discharge use of opioid consumption NUMBER OF PARTICIPANTS WHO TOOK PAIN KILLER PILLS

Posted

Number

participants

1 month

ID	Title	Description
OG000	Fentanyl	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG001	Labetalol	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG002	Esmolol	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Units	Counts
Participants	OG00025 OG00125 OG00225

Title

Denominators

Categories

Title	Measurements
	OG00015 OG00114 OG00213

Secondary

Postoperative Nausea and Vomiting

Nausea and vomiting will be measured at PACU

Posted

Number

participants

1 day

ID	Title	Description
OG000	Fentanyl	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG001	Labetalol	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG002	Esmolol	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Units	Counts
Participants	OG00025 OG00125 OG00225

Title

Denominators

Categories

Title	Measurements
	OG0009 OG0014 OG0027

Secondary

Return to Feeling Normal

Days to report to return to feeling normal, using follow up questionnaires

Posted

Mean

Standard Deviation

Days

1 month

ID	Title	Description
OG000	Fentanyl	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG001	Labetalol	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG002	Esmolol	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Units	Counts
Participants	OG00025 OG00125 OG00225

Title

Denominators

Categories

Title	Measurements
	OG00011± 9 OG00110± 9 OG00212± 10

Secondary

Patient Satisfaction Using a Verbal Rating Scale From 0 to 10

Patient satisfaction using a verbal rating scale from 0 to 10 Where a VRS is a subjective measure in which individuals verbally rated their level of satisfaction on an eleven-point numerical scale. The scale is composed of 0 (excellent satisfaction) to 10

Posted

Mean

Standard Deviation

score on a scale (0-10)

1 month

ID	Title	Description
OG000	Fentanyl	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG001	Labetalol	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG002	Esmolol	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Units	Counts
Participants	OG00025 OG00125 OG00225

Title

Denominators

Categories

Title	Measurements
	OG0009.1± 1.6 OG0019± 1.2 OG0028± 2.5

Secondary

Low Appetite

Participant who experienced low appetite (follow up questionnaire)

Posted

Number

participants

1 month

ID	Title	Description
OG000	Fentanyl	Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or Heart Rate (HR) > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG001	Labetalol	Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Esmolol: Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)
OG002	Esmolol	Esmolol 10 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Fentanyl: Fentanyl 50 micrograms/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm) Labetalol: Labetalol 5 mg/ml boluses will be given: at the induction time at the time before surgical incision, and as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)

Units	Counts
Participants	OG00025 OG00125 OG00225

Title

Denominators

Categories

Title	Measurements
	OG00015 OG0017 OG0029