- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02997800
The Effect of Intraoperative Labetalol on Time to Discharge
February 11, 2020 updated by: Dr. Robert Tanzola
The Effect of Intraoperative Labetalol on Time to Discharge and Hemodynamic Stability in Laparoscopic Cholecystectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 2V7
- Queen's University, Department of Anesthesiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Esmolol
Esmolol infusion and 1 ml saline infusion
|
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.
Every time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused.
|
Experimental: Labetalol
Labetalol Bolus and saline infusion
|
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.
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.
|
Active Comparator: Fentanyl
Fentanyl Bolus and 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative Heart Rate (HR)
Time Frame: intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.
|
heart rate (beats per min.)
|
intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.
|
Intraoperative mean arterial pressure (MAP)
Time Frame: intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.
|
blood pressure (mmHg)
|
intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.
|
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
|
The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
|
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)
|
The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
|
fentanyl required
Time Frame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
|
total fentanyl required mcg
|
The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
|
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
|
The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
|
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)
|
The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
|
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)
|
The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Tanzola, MD, FRCPC, Queen's University-Anesthesiology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
December 8, 2016
First Submitted That Met QC Criteria
December 15, 2016
First Posted (Estimate)
December 20, 2016
Study Record Updates
Last Update Posted (Actual)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Sympathomimetics
- Adrenergic beta-1 Receptor Antagonists
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Fentanyl
- Labetalol
- Esmolol
Other Study ID Numbers
- ANAE-219-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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