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临床试验/NCT05962671
NCT05962671尚未招募4 期

Opioid-sparing Versus Sevoflurane-based Anesthesia on Early Postoperative Hypoventilation in Patients Undergoing Laparoscopic Bariatric Surgery: Prospective Randomized Study

Tanta University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年8月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
72
试验地点
1
主要终点
Incidence of Early postoperative hypoventilation

研究概览

简要总结

Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared with sevoflurane-based anesthesia.

详细描述

The incidence of early postoperative hypoxemia in the literature is diverse, this may be due to multivariable, including patient-related factors, anesthesia-related factors, and surgery-related factors. Because of the controverse regarding the incidence of postoperative hypoxemia and the evidence of anesthetic technique of choice, interest in prevention and early management of early postoperative hypoxemia after laparoscopic bariatric surgery is continued.

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
None

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

  • All adult patients ≥ 18 years
  • Admitted to the post anesthesia care unit after bariatric surgery

排除标准

  • Preoperative hypoxemia which is determined by a peripheral capillary oxygen saturation (SPO2) reading of < 90% on room air

研究组 & 干预措施

Opioid-sparing based anesthesia

Active Comparator

Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.

干预措施: Opioid-sparing based anesthesia (Drug)

Sevoflurane-based anesthesia

Active Comparator

Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.

干预措施: Sevoflurane-based anesthesia (Drug)

结局指标

主要结局

Incidence of Early postoperative hypoventilation

时间窗: UP to 24 hours Postoperatively

Early postoperative respiratory hypoventilation will be defined by any of the following parameters: Oxygen saturation \< 95% for 10 seconds. Respiratory rate \< 8 breath/min. Apnea spill \> 10 seconds. pain/sedation-mismatch.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samah Mohamed Marie

Doctor resident of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

研究点 (1)

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