Effect of Lidocaine and Esmolol to Improve the Quality of Recovery

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Esmolol; Lidocaine

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

• 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.

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