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临床试验/NCT02056678
NCT02056678撤回4 期

Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家开始时间: 2014年2月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
reduction in pain scores in PACU

研究概览

简要总结

The objective of this study is to determine if IV acetaminophen administered intraoperatively can decrease the dose of narcotics required for adequate pain control and shorten recovery time in the PACU specifically in obese patients at risk for obstructive sleep apnea.

详细描述

Obese adult patients at risk for having OSA will be randomized into two groups: those receiving intraoperative IV acetaminophen and those not receiving the drug. The patients will be blinded to the administration of acetaminophen. For the group randomized to receive the study drug, anesthesia providers will be instructed to administer 1000mg of IV acetaminophen intraoperatively immediately after induction. They may utilize narcotics and other pain medication perioperatively at their discretion according to their perceived patients' needs. Post-operatively in the recovery unit, all patients will be monitored according to current standards with appropriate oxygen supplementation as needed, and they may receive narcotics or other adjuncts as ordered by the anesthesia provider. Recovery nurses will record vital signs, Aldrete score, pain score, and drugs administered per standard protocol. The recovery nurses will be blinded to the study group, and no patients regardless of control vs. study group will be allowed to receive acetaminophen in the PACU or for six hours from surgery end time due to FDA approved dosing of IV acetaminophen no more frequently than every six hours. The patients' recovery data will then be de-identified and reviewed, and each of the groups' recovery time, narcotic use, pain score, and any complications will be examined and compared.

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
Single (Participant)

入排标准

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

入选标准

  • Obesity (BMI greater than or equal to 30)
  • Symptoms of obstructive sleep apnea as determined by an OSA questionnaire patients will complete preoperatively
  • Prior diagnosis of obstructive sleep apnea
  • Undergoing laparoscopic cholecystectomy
  • 18 years old or greater

排除标准

  • Negative OSA questionnaire or recent negative workup
  • Open cholecystectomy or conversion to open procedure intraoperatively
  • Allergy to acetaminophen
  • Severe hepatic dysfunction
  • Pediatric patients
  • Patients unable to consent for themselves

研究组 & 干预措施

IV acetaminophen, OSA, laparoscopic cholecystectomy

Active Comparator

IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy

干预措施: acetaminophen, IV preparation (Drug)

结局指标

主要结局

reduction in pain scores in PACU

时间窗: PACU stay (1-2 hours)

The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in pain scores in the PACU

次要结局

  • reduced narcotic use in PACU(PACU stay (1-2 hours))
  • amount of time for recovery in PACU based on Aldrete score(PACU stay (1-2 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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