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临床试验/NCT02997800
NCT02997800已完成2 期

The Effect of Intraoperative Labetalol on Time to Discharge and Hemodynamic Stability in Laparoscopic Cholecystectomy

Dr. Robert Tanzola1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
172
试验地点
1
主要终点
Length of stay in the post-anesthesia care unit (PACU)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Esmolol

Experimental

Esmolol infusion and 1 ml saline infusion

干预措施: Esmolol (Drug)

Esmolol

Experimental

Esmolol infusion and 1 ml saline infusion

干预措施: 1 ml saline infusion (Other)

Labetalol

Experimental

Labetalol Bolus and saline infusion

干预措施: Labetalol (Drug)

Labetalol

Experimental

Labetalol Bolus and saline infusion

干预措施: saline infusion (Other)

Fentanyl

Active Comparator

Fentanyl Bolus and saline infusion

干预措施: Fentanyl (Drug)

Fentanyl

Active Comparator

Fentanyl Bolus and saline infusion

干预措施: saline infusion (Other)

结局指标

主要结局

Length of stay in the post-anesthesia care unit (PACU)

时间窗: 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

次要结局

  • adverse effects(The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).)
  • postoperative heart rate(The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).)
  • postoperative mean arterial pressure (MAP)(The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).)
  • Intraoperative Heart Rate (HR)(intraoperatively-from anesthesia induction to the surgery completion (wound closure) -approximately 45 min.)
  • Intraoperative mean arterial pressure (MAP)(intraoperatively-from anesthesia induction to the surgery completion (wound closure)-approximately 45 min.)
  • postoperative nausea and vomiting (PONV) in PACU(The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).)
  • pain scores(The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).)
  • fentanyl required(The time-frame between entry to PACU and discharge from PACU (approximately 1.5 hours).)

研究者

发起方
Dr. Robert Tanzola
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Robert Tanzola

Principal Investigator

Queen's University

研究点 (1)

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