The Effect of Intraoperative Labetalol on Time to Discharge

NCT ID: NCT02997800

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2019-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Esmolol

Esmolol infusion and 1 ml saline infusion

Group Type: EXPERIMENTAL

Esmolol

Intervention Type: DRUG

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.

1 ml saline infusion

Intervention Type: OTHER

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

Labetalol

Labetalol Bolus and saline infusion

Group Type: EXPERIMENTAL

Labetalol

Intervention Type: DRUG

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.

saline infusion

Intervention Type: OTHER

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.

Fentanyl

Fentanyl Bolus and saline infusion

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

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.

saline infusion

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

1 ml saline infusion

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Robert Tanzola

OTHER

Sponsor Role: lead

Responsible Party

Dr. Robert Tanzola

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Tanzola, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University-Anesthesiology

Locations

Queen's University, Department of Anesthesiology

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

ANAE-219-12

Identifier Type: -

Identifier Source: org_study_id