Effect of Lidocaine and Esmolol to Improve the Quality of Recovery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01114997
First received: April 23, 2010
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The purpose of this prospective, randomized, double-blinded, active-controlled study is:

To assess the effectiveness of systemic administration of lidocaine and esmolol in combination (vs. either drug alone) will result in improved postoperative outcomes for patients undergoing abdominal surgery (e.g., less pain and postoperative constipation, nausea and vomiting, faster return of bowel function, resumption of normal activities of daily living), leading to a shorten length of hospital stay, maintaining hemodynamic stability during general anesthesia, when administered as intravenous adjuvants


Condition Intervention Phase
Pain
Constipation
Nausea
Vomiting
Drug: Lidocaine
Drug: Esmolol
Drug: Lidocaine + Esmolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Effect of Lidocaine and Esmolol Alone or in Combination to Improve the Quality of Recovery, Maintaining Hemodynamic Stability During Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Post Operative Pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Outcome will have a duration of one month


Secondary Outcome Measures:
  • Opioid consumption obtained from the recorded data [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires during the first month after surgery)

  • Postoperative nausea and vomiting using a Verbal Rating Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Outcomes will be measured with follow up questionnaires during the first month after surgery

  • Return to normal activities of daily living using follow up questionnaires [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Description: return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)

  • Patient satisfaction using a verbal rating scale from 0 to 100 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    0= Not satisfied 100= Excellent

  • Hospital stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: April 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine Drug: Lidocaine
Pre-Induction: Lidocaine Loading: 1 mg/kg After Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
Esmolol Drug: Esmolol
Esmolol Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Esmolol Post Induction: Infusion dose 7.5 - 15 mcg /kg/min
Lidocaine + Esmolol Drug: Lidocaine + Esmolol

Pre-induction: Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)

Maintenance Infusion rate after Induction:

Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)


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 opiods 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo abdominal surgical procedures
  • Willingness and ability to sign an informed consent document
  • No allergies to anesthetic or analgesic medications
  • 18 - 80 years of age
  • ASA Class 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 or blood pregnancy test
  • Patients with systolic blood pressure greater than 80 and less than 150 at baseline, diastolic blood pressure less than 100 at baseline.

Exclusion Criteria:

  • Inability to comprehend the pain assessment tools.
  • 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
  • Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes
  • Patients with reactive airway disease (asthma)
  • Patients with seizures
  • Chronic use of ß-blocker or calcium channel blocker
  • Morbid obesity (body mass index >40)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114997

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Roya Yumul, MD, PhD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01114997     History of Changes
Other Study ID Numbers: Pro00020608
Study First Received: April 23, 2010
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Lidocaine Infusion
Esmolol Infusion
Anesthetic adjuvant
Abdominal surgery
Pain management
Hemodynamic stability
Perioperative outcomes
Abdominal Surgery (e.g., open hysterectomy, myomectomy, colectomy, lap colectomy, lap.-assisted vaginal hysterectomy).

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive
Esmolol
Lidocaine
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014