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临床试验/NCT02543385
NCT02543385撤回不适用

The Use of S Ketamine Versus Placebo During Target Controlled Intravenous Anaesthesia to Reduce Morphine Consumption and Side-Effects After Abdominal Hysterectomy: A Randomized Control Trial

KK Women's and Children's Hospital0 个研究点开始时间: 2014年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
S ketamine used in TAH

研究概览

简要总结

This study investigates the effect of low dose S+ketamine compared to placebo on cumulative morphine consumption at 24 hours in women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion. It compares the adverse effect profile in patients receiving S+ketamine as compared to those who did not. Participants are randomly distributed in two groups of 45 patient's each.

详细描述

In recent times it has been suggested that NMDA receptor antagonist like ketamine when used in small doses helps reducing postoperative pain and opioid consumption without compromising wakefulness and or causing its psycho mimetic adverse effect .

The clinical utility of S+ ketamine as an adjuvant intra-operatively remains controversial. The NMDA receptor activation and subsequent biochemical process has been proven to play an important role in both hyperalgesia after tissue injury and the development of opioid tolerance. Various studies have reported the advantage of S+ ketamine over traditional balanced anaesthesia, but may lead to secondary hyperalgesia and increased opioid requirement in post operative period in both animals and healthy human volunteers. Other studies showed that 48 hours continuous administration of small-dose ketamine, together with patient-controlled analgesia (PCA) with morphine, or systemic, epidural co-administration of ketamine and opiates markedly reduced cumulative morphine. However, the dosage, route and timing of administration of S+-ketamine varied in different setting.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Females above the age of 21 years old scheduled undergoing open abdominal hysterectomy with remifentanil-propofol TCI in KKH for benign condition (fibroids, adenomyosis),
  • •Be willing and able to give written informed consent for participation in this study
  • •ASA I/II patient's.

排除标准

  • •Patient with contraindications to the use of S+ketamine, as listed in the product label e.g. untreated or insufficiently treated thyroid hyperfunction, unstable angina pectoris or myocardial infarction within the last 6 months, diseases of the CNS, increased intraocular pressure and perforating ocular injuries, surgical procedures in the upper respiratory tract, etc
  • •Patients with a h/o drug or alcohol abuse
  • •Regular use of analgesics, or use of opioids within 12 hours of surgery
  • •Patient on chronic use of benzodiazepine or neurololeptics
  • •Patient on thyroid replacement hormone
  • •H/o IHD,HTN,Thyroid disorder.
  • •BMI> 30kg/m
  • •H/o Psychiatric disorder.
  • •Laproscopic surgery converted to open surgery.
  • •Pregnant or breast feeding female's.

研究组 & 干预措施

SKET

Active Comparator

Intravenous S+ketamine 0.25 mg/kg (i.v. bolus) at the beginning and 0.25 mg/kg (i.v. bolus) 20 minutes before extubation along with remifentanil according to Minto model and propofol infusion according to Schnider model through target control infusion pump.

干预措施: S Ketamine (Drug)

PLACEBO

Placebo Comparator

Intravenous normal saline (as placebo, with similar volume) at the beginning and 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Schnider model through target control infusion pump.

干预措施: S Ketamine (Drug)

结局指标

主要结局

S ketamine used in TAH

时间窗: 1 YEAR

次要结局

未报告次要终点

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sng Ban Leong

Principal Investigator

KK Women's and Children's Hospital

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