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临床试验/NCT03727607
NCT03727607已完成2 期

A Randomized Controlled Trial - Total Intravenous Anaesthesia Versus Inhaled Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery. Postoperative Pain and Nausea

Ostfold Hospital Trust0 个研究点目标入组 160 人开始时间: 2016年1月30日最近更新:
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
160
主要终点
Degree of pain after surgery

研究概览

简要总结

Many factors during laparascopic surgery leads to PONV (postoperative nausea and vomiting), such as C02 insufflations causing peritoneal stretch and irritation and type of anaesthesia given during surgery.

The two anesthetic techniques used in bariatric surgery are gas anesthesia (Remifentanil TCI and Desfluran) and Total Intra Venous Anesthesia (TIVA) with propofol. There are studies which have shown a reduction in postoperative nausea and vomiting following TIVA, and there are publications showing no statistically significant difference.

The aim of this study was to investigate the best anaesthetic approach for obese subjects, evaluating awakening time, postoperative nausea and pain.

Our hypothesis was based on the fact that Propofol is a lipid-soluble anesthetic and therefore might have a prolonged effect in obese patients, leading to a longer awakening time along with postoperative nausea and vomiting. This hypothesis is also described earlier by obese patients have more depots (bulk fat) and also more fat surface making anaesthetics storage more easier, and also that the anesthetic will return into the circulation when the administration is stopped [18].

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ≥35 kg/m2 with at least one comorbid condition or BMI ≥40 kg/m2.

排除标准

  • drug abuse
  • severe mental illness
  • serious medical condition; cancer, end-stage lung disease (ASA>3) or allergies to any drugs used in the study

研究组 & 干预措施

Gass

Active Comparator

DESFLURANE ANESTHESIA

干预措施: Desflurane (Drug)

TIVA

Active Comparator

TOTAL INTRAVENOUS ANESTHESIA

干预措施: Desflurane (Drug)

结局指标

主要结局

Degree of pain after surgery

时间窗: 48 hours post surgery

Noted using NRS scale (from 0-10)

Degree of nausea and vomiting after surgery

时间窗: 48 hours postsurgery

Noted using NRS scale (from 0-10)

Awakening time after surgery

时间窗: 2 hours postdose

time noted from anaesthesia stoped to patients awake

次要结局

未报告次要终点

研究者

发起方
Ostfold Hospital Trust
申办方类型
Other
责任方
Sponsor

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