Effect of Lidocaine and Esmolol to Improve the Quality of Recovery

NCT01114997 | Terminated Phase 4 Results

• 1 other identifier: Pro00020608
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Constipation; Nausea; Vomiting

Keywords

Lidocaine Infusion; Esmolol Infusion; Anesthetic adjuvant; Abdominal surgery; Pain management; Hemodynamic stability; Perioperative outcomes

Outcome Measures

Primary Outcomes (2)

• Post Operative Pain

  Outcome had a duration of one day at post-anesthesia care unit (PACU) Postoperative pain measured using a Verbal Rating Scale (VRS) Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain.

  1 day

• Number of Participants With Post Operative Pain One Month After Surgery

  Highest Post Operative pain one month after surgery, using a verbal rating score from 0 (no pain) to 10 (highest level of pain). Patient received a post-operative follow-up call one month after surgery.

  1 month

Secondary Outcomes (5)

• Opioid Consumption Obtained From the Recorded Data

  1 day

• Number of Participants With Postoperative Nausea One Day After Surgery

  1day

• Return to Normal Activities of Daily Living Using Follow up Questionnaires

  1 month

• Patient Satisfaction

  1 month

• Post-anesthesia Care Unit (PACU) Stay

  1 day

Study Arms (3)

Lidocaine

ACTIVE COMPARATOR

Pre-Induction: Lidocaine Loading: 1 mg/kg Post- Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)

Drug: Lidocaine

Esmolol

ACTIVE COMPARATOR

Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Post-Induction: Infusion dose 7.5 - 15 mcg /kg/min

Drug: Esmolol

Lidocaine + Esmolol (Combo)

EXPERIMENTAL

Performed with the administration of both drugs. Pre-induction: Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg) Post-induction: Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)

Drug: Lidocaine + Esmolol (Combo)

Interventions

Lidocaine DRUG

Pre-Induction: Lidocaine Loading: 1 mg/kg After Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)

Lidocaine

Esmolol DRUG

Esmolol Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Esmolol Post Induction: Infusion dose 7.5 - 15 mcg /kg/min

Esmolol

Lidocaine + Esmolol (Combo) DRUG

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)

Lidocaine + Esmolol (Combo)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo abdominal surgical procedures
• Willingness and ability to sign an informed consent document
• No allergies to anesthetic or analgesic medications
• years of age
• American Society of Anesthesiologists (ASA) physical status classification: 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pain; Constipation; Nausea; Vomiting; Agnosia

Interventions

Lidocaine; esmolol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Roya Yumul
• Organization: Cedars Sinai Medical Center

Roya.Yumul@cshs.org

310-423-1682

Study Officials

• Roya Yumul, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency program director, Department of anesthesiology

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 3, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 3, 2016
• Results First Posted: June 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)