跳至主要内容
临床试验/CTRI/2024/10/075181
CTRI/2024/10/075181尚未招募2 期

Effects of pregabalin on perioperative opioid-sparing effects on patients undergoing craniotomies for brain tumors. A Randomized, double-blinded, placebo controlled study.

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月22日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
a]Total intra-operative opioid consumption

研究概览

简要总结

• A craniotomy is a neurosurgical procedure done to get a wide cranial opening for doing surgical therapeutic maneuvers. Posi-craniotomy pain is a common entity. Pain can elicit a complex set of neural, and cardiac. and respiratory changes, leading to increased cerebral blood flow and intracranial pressure, cerebral edema, and even intracranial bleeding operative analgesics. Traditionally, opioids are being used in craniotomy cases for induction, intraoperative pain management, and post• operative pain management. Opioids are potent analgesics but their usage can interfere with neurological monitoring and are associated with serious side effects like PONV, constipation, pruritis, sedation, opioid-induced hyperalgesia (OIH), and life-threatening respiratory depression.  Pregabalin has been evaluated for postoperative analgesia in orthopedic and spine surgeries, laparoscopic hysterectomy, laparoscopic cholecystectomy, and thoracotomy, etc., Preemptive use of gabapentinoids is also known to effectively reduce opioid consumption There is a deficiency of trials investigating its effects in attenuating perioperative pain in intracranial surgeries. This study was designed to evaluate the opioid-sparing effect of preoperative pregabalin in patients undergoing craniotomy for brain tumors Studies of pregabalin in neurosurgical patients are scarce. There are only a few published randomized studies of pregabalin use for analgesia in patients undergoing craniotomy and these limited studies compare pre-emptive pregabalin and gabapentin and their opioid-sparing effects. However, these studies have some drawbacks like using sub-therapeutic doses of pregabalin, non-consideration of opioid side effects, and prolonged postoperative use of pregabalin, which we would like to correct in our study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender 2) Age 18–65 years 3) ASA class I, II 4) Patients with GCS 15 5) Scheduled for elective craniotomies for excision of brain tumors.

排除标准

  • Allergy to study drugs and opioid dependence.
  • Patients undergoing emergency surgery.
  • Patients receiving chronic neuroleptics, tricyclic antidepressants, serotonin noradrenaline reuptake inhibitors.

结局指标

主要结局

a]Total intra-operative opioid consumption

时间窗: a]Till 12 hours postoperative | b]Till 12 hours postoperative

b] Post-operative pain scores and rescue analgesia.

时间窗: a]Till 12 hours postoperative | b]Till 12 hours postoperative

次要结局

  • a] Incidence of adverse effects of opioids like PONV, shivering.(b] Incidence of emergence delirium and delayed recovery.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Sai Saravanan K

AIIMS, RAIPUR

研究点 (1)

Loading locations...

相似试验