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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esmolol | Experimental | Esmolol infusion and 1 ml saline infusion |
|
| Labetalol | Experimental | Labetalol Bolus and saline infusion |
|
| Fentanyl | Active Comparator | Fentanyl Bolus and saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Heart Rate (HR) | heart rate (beats per min.) | intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min. |
| Intraoperative mean arterial pressure (MAP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Tanzola, MD, FRCPC | Queen's University-Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University, Department of Anesthesiology | Kingston | Ontario | K7L 2V7 | Canada |
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| ID | Term |
|---|---|
| C036604 | esmolol |
| D007741 | Labetalol |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| 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. |
|
blood pressure (mmHg)
| intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min. |
| postoperative nausea and vomiting (PONV) in PACU | incidence of nausea and vomiting | The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours). |
| pain scores | pain scores visual analogue scale (VAS) | The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours). |
| fentanyl required | total fentanyl required mcg | The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours). |
| adverse effects | Any reported adverse effects or complications | The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours). |
| postoperative heart rate | 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) | blood pressure (mmHg) | The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours). |
| D012457 |
| Salicylamides |
| D000577 | Amides |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |