Labetalol and Esmolol: Vital Signs and Post Operative Pain Management



Status:Completed
Conditions:Post-Surgical Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:18 - 80
Updated:8/26/2018
Start Date:September 2009
End Date:August 2018

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Randomized, Double-Blinded, Active-Controlled Study to Evaluate the Intraoperative Use of Labetalol vs. Esmolol for Maintaining Hemodynamic Stability During Laparoscopic Surgery: Effect on Recovery and Postoperative Pain

This study proposes to investigate the effects of labetalol or esmolol on managing the vital
signs (like blood pressure and heart rate) during surgery, on pain management, and on the
later recovery after surgery.

It will also assess the cost-effectiveness of Labetalol and esmolol for outpatient surgery.

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.

Inclusion Criteria:

- Patients scheduled to undergo outpatient 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) physical status classification 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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-5841
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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