The Effect of Intraoperative Labetalol on Time to Discharge

Summary

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.

Conditions

• Bloodpressure
• Heart Rate

Interventions

DRUG

Esmolol

Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) \>20% of baseline will be treated with an initial intravenous bolus of esmolol 30 mg IV (30 mg in 5 ml of normal saline). An intravenous esmolol infusion will be initiated at 5mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5mcg/kg/min each time HR or MAP \>20% of baseline. An intravenous bolus of placebo (normal saline 1 ml) will be administered whenever a change to the infusion rate is made.

DRUG

Labetalol

Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) \>20% of baseline will be treated with an initial intravenous bolus of labetalol 10 mg IV (10 mg in 5 ml of normal saline). Any further increases in HR or MAP \>20% of baseline will be treated with intravenous boluses of labetalol 5 mg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.

DRUG

Fentanyl

Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) \>20% of baseline will be treated with an initial intravenous bolus of fentanyl 50 mcg IV (50 mcg in 5 ml of normal saline). Any further increases in HR or MAP \>20% of baseline will be treated with intravenous boluses of fentanyl 25 mcg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.

OTHER

saline infusion

An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus drug dose (fentanyl or labetalol depending upon randomization) and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.

OTHER

1 ml saline infusion

Every time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused.

Sponsors & Collaborators

• Dr. Robert Tanzola

  lead OTHER

Principal Investigators

• Robert Tanzola, MD, FRCPC · Queen's University-Anesthesiology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2019-01-31

Completion

2019-01-31

Countries

• Canada

Study Locations