The Effect of Intraoperative Labetalol on Time to Discharge

Dr. Robert Tanzola

Status and phase: Completed; Phase 2

Conditions: Bloodpressure; Heart Rate

Treatments: Drug: Fentanyl; Other: saline infusion; Other: 1 ml saline infusion; Drug: Labetalol; Drug: Esmolol

Study type: Interventional

Funder types: Other

Identifiers

NCT02997800

ANAE-219-12

Details and patient eligibility

About

Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain. Opioids however have many unpleasant side effects including nausea and vomiting, itching, sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood pressure are often attributed to pain. It has been shown that by treating these changes with medications such as esmolol, instead of opioids, side effects and time to discharge from hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have advantages over it. It is more effective at controlling both heart rate and blood pressure and it is easier and less costly to use. This study is investigating labetalol in patients having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients will be treated with one of these drugs during surgery to control heart rate and blood pressure and the effects on time to discharge, pain scores, frequency of side effects, and narcotic requirements will be observed in the recovery room. It is thought that labetalol will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will show reduced time to discharge, fewer side effects, and effective treatment of heart rate and blood pressure.

Enrollment: 172 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled to undergo elective ambulatory laparoscopic cholecystectomy under general anesthesia
• American Society of Anesthesiologist's Status ASA) 1-3
• able to understand and sign informed consent

Exclusion criteria

• known allergy to any of the study medications including beta blockers, fentanyl, acetaminophen, non-steroidal anti-inflammatories or local anesthetics
• chronic use of beta-adrenergic receptor antagonists or opioids
• conversion to open cholecystectomy
• History of renal, hepatic or cardiac failure, reactive airway disease
• Medical history that in the investigator's judgement would interfere with the protocol or assessments
• Unable to understand pain assessment
• Failure to give informed consent
• pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

172 participants in 3 patient groups

Esmolol

Experimental group

Description:

Esmolol infusion and 1 ml saline infusion

Treatment:

Drug: Esmolol

Other: 1 ml saline infusion

Labetalol

Experimental group

Description:

Labetalol Bolus and saline infusion

Treatment:

Other: saline infusion

Drug: Labetalol

Fentanyl

Active Comparator group

Description:

Fentanyl Bolus and saline infusion

Treatment:

Other: saline infusion

Drug: Fentanyl