跳至主要内容
临床试验/CTRI/2024/08/072344
CTRI/2024/08/072344尚未招募不适用

Effect of low dose ketamine with dexmedetomidine vs fentanyl on anesthetic requirements, intraoperative hemodynamics and recovery profile in patients undergoing elective thoracic and lumbar spine surgeries.

Jagarapu kusuma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To access the effect of low dose Ketodex infusion on intraoperative analgesic and anaesthetic requirements(amount of anesthetic and analgesics used)

研究概览

简要总结

Spinal surgeries involve hemodynamic alterations, blood loss, anaesthetic and analgesic requirements. With the use of increasing doses of opioids in the intraoperative period, there have been incidents of central sensitization, allodynia and post operative nausea and vomiting.

Dexmedetomidine has been widely used as an anaesthetic adjuvant for its opioid sparing effects. It decreases sympathetic tone, reduces heart rate and has the propensity to develop hypotension.

Ketamine has also been used as an anaesthetic adjuvant in low doses for its opioid sparing effects3 and reduced post operative nausea and vomiting. Ketamine stimulates the cardio-respiratory system and can have psychomimetic adverse effects.

A combination of dexmedetomidine and ketamine has low incidence of adverse effects, good analgesic, predictable recovery and no cardiorespiratory depression and reduce opioid usage.

The primary aim of our study will be, to compare its effect on intraoperative analgesic and anaesthetic requirements. The secondary aim will be, to compare intraoperative hemodynamic profile, blood loss during the surgery and emergence from anaesthesia.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age group 18 to 70 years ASA status 1 or 2 Patients undergoing elective thoracic/ lumbar spine surgery under general anaesthesia.

排除标准

  • Age group below 17 and above 70 years 2.ASA status III and above
  • Pregnancy
  • Patients for emergency surgical procedures
  • Patients with uncontrolled hypertension or uncontrolled Diabetes mellitus
  • Patients with cardiac dysfunction such as ischemic heart disease, heart blocks, valvular disease and heart failure 7 Patients with severe respiratory disease such as asthma or chronic obstructive pulmonary disease.
  • Patients with severe hepatic, renal or endocrine disease
  • Patients who have undergone prior spine surgeries
  • Patients with history of drug abuse.

结局指标

主要结局

To access the effect of low dose Ketodex infusion on intraoperative analgesic and anaesthetic requirements(amount of anesthetic and analgesics used)

时间窗: Intra operative , post induction to extubation.

次要结局

  • To access the effect of low dose Ketodex infusion on intraoperative hemodynamic profile, blood loss during the surgery and emergence from anaesthesia.(Intra operative , post induction to extubation.)

研究者

发起方
Jagarapu kusuma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr H S Murthy

Manipal Hospitals

研究点 (1)

Loading locations...

相似试验