Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery for Haemodynamic Stability and Recovery Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To measure the emerence and extubation times in both groups
研究概览
简要总结
This study has been planned to compare the effect of opioid free anaesthesia using dexmedetomidine and ketamine with opioid based anaesthesia using fentanyl in maintaining the intraoperative hemodynamic stability and recovery characteristics in patients undergoing Transsphenoidal surgery of pituitary tumors.
详细描述
Opioid Free Anesthesia (OFA) is a technique where no intraoperative opioid is administered during the anesthetic management. Opioid free anesthesia is usually achieved through sympatholysis, analgesia, and anesthesia with dexmedetomidine and analgesia with low dose ketamine. In addition paracetamol and other non-steroidal anti inflammatory drugs (NSAIDS) may be used as adjuncts to the multi-modal pain regimen.
Dexmedetomidine, a highly selective agonist of the alpha2 adrenergic receptor, has many clinical benefits, such as sedation, analgesia, preventing unwanted stress responses and low risk of respiratory depression. Because of concern that opioids might cause perioperative respiratory depression, substitution with dexmedetomidine will be helpful with its analgesic and sympatholytic properties. Dexmedetomidine has shown to reduce minimum alveolar concentration (MAC) of inhalational anesthetics and the requirement of perioperative opioid by 30-50%. In neurosurgical patients, dexmedetomidine is helpful in maintaining intracranial pressure (ICP) and intraoperative hemodynamic stability, especially during intubation and extubation. It can allow for faster awakening and thus an earlier neurological examination by decreasing necessary volatile agent and opioid doses.
Ketamine, an N-methyl-d-aspartate(NMDA) antagonist, blunts central pain sensitization at sub-anesthetic doses (0.5 mg/kg or less) and has been studied extensively as an adjunct for perioperative analgesia. Sub-anesthetic ketamine improves pain scores and reduces perioperative opioid consumption in a broad range of surgical procedures.Recent literature has suggested that adjuvant ketamine administration in mechanically ventilated patients has no cerebrovascular effects.
The present study has been planned to compare the effect of opioid free anesthesia using dexmedetomidine and ketamine with opioid based anesthesia using fentanyl in maintaining the intraoperative hemodynamic stability and recovery characteristics in patients undergoing TSS of pituitary tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients suffering significant pituitary adenocarcinomas posted for transsphenoidal resection of tumor
- •age group between 18 to 65 yr
- •Both males and females
- •ASA physical status 1 to 2
排除标准
- •pts taking opioid for chronic pain
- •Pregnant or nursing woman
- •Preoperative GCS <15
- •HR<50/min
- •Patients with allergies to study medication
- •Patients with psychiatric disorder
- •Patients with unstable cardiorespiratory disorder
- •Patients with hepatic and renal insufficiency
研究组 & 干预措施
Dexmedetomidine and ketamine
The group will receive loading dose of dexmedetomidine 1mcg/kg over 10 Min followed by a maintenance of 0.5 mcg/ kg/ hr.ketamine 0.5 mg/kg will be given as bolus at the time of induction.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine and ketamine
The group will receive loading dose of dexmedetomidine 1mcg/kg over 10 Min followed by a maintenance of 0.5 mcg/ kg/ hr.ketamine 0.5 mg/kg will be given as bolus at the time of induction.
干预措施: Ketamine (Drug)
fentanyl and placebo
pts will receive fentanyl 2mcg/kg as bolus over 10 Mon followed by 1 mcg/ kg/hr as maintenance, instead of ketamine placebo(0.9%saline ) will be given in control group
干预措施: Fentanyl (Drug)
fentanyl and placebo
pts will receive fentanyl 2mcg/kg as bolus over 10 Mon followed by 1 mcg/ kg/hr as maintenance, instead of ketamine placebo(0.9%saline ) will be given in control group
干预措施: Placebos (Drug)
结局指标
主要结局
To measure the emerence and extubation times in both groups
时间窗: 15minutes
it is measured by noting the time for emergence and extubation after stopping inhalational anaesthesia.
to measure the level of emergence in both the groups
时间窗: 15min
using Riker sedation-agitation score
to measure the level of cognition in both the groups
时间窗: 15min
using Short orientation memory concentration test (SOMC test)
次要结局
- comparison of intraoperative hemodynamic stability in both the groups(intra operative period)
- postoperative pain assessment by using numeric rating scale(24 hrs)
- comparing postoperative analgesic dose requirement in both the groups(24hrs)
研究者
Ayyawar Hareesh
principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh