The Effect of Intraoperative Labetalol on Time to Discharge

NCT02997800 | Completed Phase 2

• 1 other identifier: ANAE-219-12
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Length of stay in the post-anesthesia care unit (PACU)

  time from arrival in PACU after surgery until discharge from PACU

  The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).

Secondary Outcomes (8)

• Intraoperative Heart Rate (HR)

  intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.

• Intraoperative mean arterial pressure (MAP)

  intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.

• postoperative nausea and vomiting (PONV) in PACU

  The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).

• pain scores

  The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).

• fentanyl required

  The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).

Study Arms (3)

Esmolol

EXPERIMENTAL

Esmolol infusion and 1 ml saline infusion

Drug: Esmolol; Other: 1 ml saline infusion

Labetalol

EXPERIMENTAL

Labetalol Bolus and saline infusion

Drug: Labetalol; Other: saline infusion

Fentanyl

ACTIVE COMPARATOR

Fentanyl Bolus and saline infusion

Drug: Fentanyl; Other: saline infusion

Interventions

Esmolol 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.

Esmolol

Labetalol 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.

Labetalol

Fentanyl 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.

Fentanyl

saline infusion 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; Labetalol

1 ml saline infusion OTHER

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

Esmolol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Robert Tanzola: lead

Study Sites (1)

Queen's University, Department of Anesthesiology

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Interventions

esmolol; Labetalol; Fentanyl

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert Tanzola, MD, FRCPC

  Queen's University-Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 20, 2016
• Study Start: November 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

CA (1)