The Effect of Intraoperative Labetalol on Time to Discharge

Phase 2

Completed

• Conditions: Heart Rate; Bloodpressure
• Interventions: Drug: Esmolol; Drug: Fentanyl; Drug: Labetalol; Other: 1 ml saline infusion; Other: saline infusion

• Registration Number: NCT02997800
• Lead Sponsor: Dr. Robert Tanzola

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-20
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esmolol	Esmolol	Esmolol infusion and 1 ml saline infusion
Esmolol	1 ml saline infusion	Esmolol infusion and 1 ml saline infusion
Labetalol	saline infusion	Labetalol Bolus and saline infusion
Fentanyl	Fentanyl	Fentanyl Bolus and saline infusion
Fentanyl	saline infusion	Fentanyl Bolus and saline infusion
Labetalol	Labetalol	Labetalol Bolus and saline infusion

Primary Outcome Measures

Name	Time	Method
Length of stay in the post-anesthesia care unit (PACU)	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 Outcome Measures

Name	Time	Method
adverse effects	The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).	Any reported adverse effects or complications
postoperative heart rate	The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).	heart rate (beats per min)
postoperative mean arterial pressure (MAP)	The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).	blood pressure (mmHg)
Intraoperative Heart Rate (HR)	intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.	heart rate (beats per min.)
Intraoperative mean arterial pressure (MAP)	intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.	blood pressure (mmHg)
postoperative nausea and vomiting (PONV) in PACU	The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).	incidence of nausea and vomiting
pain scores	The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).	pain scores visual analogue scale (VAS)
fentanyl required	The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).	total fentanyl required mcg

Trial Locations

Locations (1)

Queen's University, Department of Anesthesiology; 🇨🇦 Kingston, Ontario, Canada