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OpenTrials
Completed

NCT Number: NCT02997800

The Effect of Intraoperative Labetalol on Time to Discharge

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.

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Key information

Conditions

Bloodpressure Heart Rate

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen's University, Department of Anesthesiology

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

1 ml saline infusion

Other

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

Primary outcomes

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

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

    time from arrival in PACU after surgery until discharge from PACU

Secondary outcomes

  1. Intraoperative Heart Rate (HR)

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

    heart rate (beats per min.)

  2. Intraoperative mean arterial pressure (MAP)

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

    blood pressure (mmHg)

  3. postoperative nausea and vomiting (PONV) in PACU

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

    incidence of nausea and vomiting

  4. pain scores

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

    pain scores visual analogue scale (VAS)

  5. fentanyl required

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

    total fentanyl required mcg

  6. adverse effects

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

    Any reported adverse effects or complications

  7. postoperative heart rate

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

    heart rate (beats per min)

  8. postoperative mean arterial pressure (MAP)

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

    blood pressure (mmHg)

Sponsors and collaborators

Lead sponsor

Dr. Robert Tanzola

Other

Registry information

Official study title

The Effect of Intraoperative Labetalol on Time to Discharge and Hemodynamic Stability in Laparoscopic Cholecystectomy

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2016
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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