Low Dose Perioperative Ketamine Infusion and it's Effect on Postoperative Pain Score, Sedation Score and Narcotic Consumption in Patients Undergoing Spine Surgery: A Prospective Randomized Double Blind Control Trial.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- post operative pain score
研究概览
简要总结
Low dose perioperative ketamine infusion and it's effect on postoperative pain score, sedation score and narcotic consumption in patients undergoing spine surgery: A prospective randomized double blind control trial.
详细描述
Low dose perioperative ketamine infusion and it's effect on postoperative pain score, sedation score and narcotic consumption in patients undergoing spine surgery: A prospective randomized double blind control trial.
INTRODUCTION:
Recent advances in pain management advoctes the use of multimodal approach for post-operative pain therapy, as it reduces the side effects of individual drugs and attenuate pain responses at various sites in painpathways.. 6 if pain is not sufficiently managed, it can lead to various post-surgical complications and chronic pain..4 opiods are one of the commonly used drugs for provision of balanced anaesthesia as well as analgesia in the post surgical period. The use of opioids lead to various side effects, acute tolerance and hefty financial constraints if used in larger doses. In Pakistan, easy availability of narcotics also cause difficulty in choice of analgesics in post-operative pain.3 Ketamine , a phencyclidine derivative and dissociative anesthetic agent can cause significant analgesia when used in subanesthetic doses..1 it possess centrally mediated analgesic potential without any significant effect on patient's wakefulness and perception in dose of ≤0.3 mg/kg IV.2 Consensus guidelines on the use of intravenous ketamine for acute pain management from the American Society of Regional Anaesthesia and Pain Medicine, the American Academy of Pain Medicine and the American Society of Anaesthesiologists 2018 supports the use of sub anesthetic bolus dose of ketamine up to 0.35 mg/kg and infusions up to 1 mg/kg/hour for acute pain as adjuncts to opioids for perioperative analgesia.1 Low-dose IV ketamine infusion decrease opioid requirement by 40%. It also decreases pain scores, but these findings are less clear. No significant adverse effects have been reported with low-dose IV infusion of ketamine when used up to 48 hours after surgery5 We conducted this study to evaluate the effects of perioperative sub-anesthetic ketamine infusion, when continued in the post-operative period for 24 hours, on post-operative pain and sedation scores, overall narcotic and analgesics comsumptions and side effects in patients undergoing spine surgery in local population. Literature review did not show any such study conducted in Pakistan till date, results of this study can help innovate strategies of multimodel analgesia In local population.
Onjective:
The main objective of this study is to compare the effects of perioperative low dose ketamine infusion on postoperative pain , sedation score, adverse effects and total analgesics consumption in a placebo-controlled design Hypothesis Perioperative low dose ketamine infusion decreases the visual analogue score and total analgesic consumption without profound side effects in the study group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
double blind
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
- •A total of 60 adult patients aged between 18 and 60 years old with American Society of Anesthesiology (ASA) physical status I-II scheduled for elective spine surgery
排除标准
- •BMI more than 40 kg/m2
- •poorly controlled arterial hypertension (blood pressure higher than 140/90 mmHg)
- •respiratory, liver or kidney disease
- •heart disease (heart block or myocardial ischemia)
研究组 & 干预措施
group A
WIll be given low dose perioperative ketamine infusion, as well as a ketamine bolus at start of surgery.
干预措施: Ketamine Hydrochloride (Drug)
group B
will be given normal saline infusion and bolus at start of surgery.
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
post operative pain score
时间窗: upto 24 hours
visual analogue scoring will be done for 24 hours post-operatively
次要结局
未报告次要终点
研究者
dr. sana siddiq
assistant professor
Services Institute of Medical Sciences, Pakistan
