Clinical trial NCT02997800: The Effect of Intraoperative Labetalol on Time to Discharge
Official title: The Effect of Intraoperative Labetalol on Time to Discharge and Hemodynamic Stability in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bloodpressure
Heart Rate
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Length of stay in the post-anesthesia care unit (PACU)
timeFrame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
Secondary outcomes:
measure: Intraoperative Heart Rate (HR)
timeFrame: intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.
measure: Intraoperative mean arterial pressure (MAP)
timeFrame: intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.
measure: postoperative nausea and vomiting (PONV) in PACU
timeFrame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
measure: pain scores
timeFrame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
measure: fentanyl required
timeFrame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
measure: adverse effects
timeFrame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
measure: postoperative heart rate
timeFrame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
measure: postoperative mean arterial pressure (MAP)
timeFrame: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University, Department of Anesthesiology
state: Ontario
Study officials:
affiliation: Queen's University-Anesthesiology
name: Robert Tanzola, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: