BloodpressurePhase 2NCT02997800
The Effect of Intraoperative Labetalol on Time to Discharge
A Phase 2 study testing Esmolol, Labetalol and Fentanyl in people with Bloodpressure and Heart Rate, run by Dr. Robert Tanzola at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bloodpressure, Heart Rate
- What is being tested?
- Esmolol, Labetalol and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen's University, Department of Anesthesiology
Kingston, Ontario, K7L 2V7
About this study
Official title: 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.
- Conditions
- Bloodpressure, Heart Rate
- Being tested
- Esmolol, Labetalol, Fentanyl, saline infusion, 1 ml saline infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
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.
LabetalolDrug
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.
FentanylDrug
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 infusionOther
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 infusionOther
Every time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused.
| Study group | Role | What they receive |
|---|---|---|
| Esmolol | Experimental | Esmolol infusion and 1 ml saline infusion Receives: Drug: Esmolol; Other: 1 ml saline infusion |
| Labetalol | Experimental | Labetalol Bolus and saline infusion Receives: Drug: Labetalol; Other: saline infusion |
| Fentanyl | Active comparator | Fentanyl Bolus and saline infusion Receives: Drug: Fentanyl; Other: saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in the post-anesthesia care unit (PACU)
time from arrival in PACU after surgery until discharge from PACU
Measured: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
Secondary outcomes (8)
Intraoperative Heart Rate (HR)
heart rate (beats per min.)
Measured: intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.
Intraoperative mean arterial pressure (MAP)
blood pressure (mmHg)
Measured: 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
Measured: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
pain scores
pain scores visual analogue scale (VAS)
Measured: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
fentanyl required
total fentanyl required mcg
Measured: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
adverse effects
Any reported adverse effects or complications
Measured: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
postoperative heart rate
heart rate (beats per min)
Measured: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
postoperative mean arterial pressure (MAP)
blood pressure (mmHg)
Measured: The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startNov 2012
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloodpressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Robert Tanzola
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Robert Tanzola, Queen's University
- Investigators
- Robert Tanzola, MD, FRCPC, Principal investigator, Queen's University-Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997800
- Sponsor's protocol ID
- ANAE-219-12
- Status last verified
- Feb 2020
- First submitted
- 8 Dec 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Labetalol on Time to Discharge and Hemodynamic Stability in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02997800
- Acronym / sponsor ID
- ANAE-219-12
- Conditions
- Bloodpressure, Heart Rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Dr. Robert TanzolaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esmolol | Experimental | Drug: Esmolol, Other: 1 ml saline infusionEsmolol infusion and 1 ml saline infusion |
| Labetalol | Experimental | Drug: Labetalol, Other: saline infusionLabetalol Bolus and saline infusion |
| Fentanyl | Active comparator | Drug: Fentanyl, Other: saline infusionFentanyl Bolus and saline infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsmololFollowing 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. | Drug | Esmolol |
| LabetalolFollowing 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. | Drug | Labetalol |
| FentanylFollowing 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. | Drug | Fentanyl |
| saline infusionAn 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. | Other | Fentanyl, Labetalol |
| 1 ml saline infusionEvery time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused. | Other | Esmolol |
Primary outcome
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
8 secondary outcomes
Intraoperative Heart Rate (HR)
Time frame: 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.
postoperative nausea and vomiting (PONV) in PACU
Time frame: 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).
fentanyl required
Time frame: 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).
postoperative heart rate
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
Related trials for Bloodpressure
Recruiting
Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals
Bloodpressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Tanzola, MD, FRCPC principal investigator
Queen's University-Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esmolol, Labetalol and Fentanyl in people with Bloodpressure and Heart Rate, run by Dr. Robert Tanzola at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.