A randomized controlled comparison of emergence agitation and recovery profile between desflurane and sevoflurane anaesthesia in adults after laparoscopic surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Severity of emergence agitation by Aonos Four point Scale
研究概览
简要总结
Laparoscopic surgery is one of the most importantdiagnostic and therapeutic tools in the present surgical practice and hasbecome the gold standard of minimal access surgery. The benefits of minimalaccess techniques include less pain, early mobilization, improved cosmeticaspects and shorter hospital stay, which have further increased itsapplications.The major problems during laparoscopic surgery are related to thecardiopulmonary effect of pneumoperitoneum, systemic carbon dioxide absorption,venous gas embolism, unintentional injuries to intraabdominal structures andpatient positioning.Anaesthesia and surgery have certain inevitable negativeimpacts on the quality of life of patients, manifest as various discomfortsafter surgery even without specific complications. Moreover, prolonged recoveryafter surgery can lead to delayed hospital discharges and increased costs,which can impact resource utilization and mitigate patient satisfaction.Qualityof recovery directly highlight the late recovery profile and reflects thehigh-quality anaesthetic services in an economically constrained healthcareenvironment.Emergence agitation (EA) after general anaesthesia is a pressingconcern for anaesthesiologists, commonly seen in immediate post anaestheticperiod.During the last few decades, the new volatile anaesthetics, sevofluraneand desflurane became commonly available in clinical practice.Thepharmacokinetic properties of sevoflurane and desflurane offer firm control ofanaesthesia and reduce the time for emergence from general anaesthesia, thereby reducing procedure time and have the capacity to make anaesthesia even saferin high risk patients.Presently, the emergence effects of aforesaidinhalational anaesthetics is still not fully elucidated in adults.Wehypothesized that difference in the intrinsic characteristics and the speed ofemergence, of the two inhalational anaesthetics, would have direct effect onthe progression of emergence agitation and recovery profile in adults. The aimof this prospective randomized double-blind study is to compare emergenceagitation and recovery profile between desflurane and sevoflurane anaesthesiain adult patients undergoing laparascopic surgery.we will be using Qor-40score, which is now one of the most recent and extensively validatedrating scale to measure the quality of recovery after surgery and anaesthesiain clinical and research situations. and also to evaluate the severity ofemergence state by using a four-point categorical scale based on Aono‘s scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 18 and 60 years.
- •American Society of Anaesthesiologist (ASA) physical status I and II
- •Patients scheduled for elective laparoscopy surgery under general anaesthesia with duration of surgery less than 90 minutes.
排除标准
- •Patients with clinically significant cardiovascular, respiratory, hepato-renal, endocrine or metabolic disorders.
- •Patients with gastro-esophageal reflux disease.
- •Patients with neuropsychiatric disorders.
- •Patients with mental retardation.
- •Patients taking any central nervous system depressants.
- •Patients on chronic opioids, corticosteroids or any sleep aid drugs.
- •Patients having alcohol or any drug abuse.
- •10.Pregnant and breastfeeding patients.
结局指标
主要结局
Severity of emergence agitation by Aonos Four point Scale
时间窗: 1.Immediately after the PLMA is removed in the Operating Room. | 2.At admission in PACU. 3.Thereafter every 10 minutes in the recovery period, till the patient is discharged from PACU.
次要结局
- Quality of Recovery by QOR-40 score.(1.The day before surgery (baseline))
- Severity of anxiety using an 11-point numeric rating score (NRS)(1.In Preoperative room.)
- Severity of pain using an 11-point numeric rating score (NRS)(1.In Preoperative room.)
- Severity of nausea/vomiting using an 11-point numeric rating score (NRS)(1.In Preoperative room.)
- Mean Arterial Pressure(1.Prior to induction)
- Saturation of Oxygen in Blood.(1.Prior to induction)
- Any perioperative complications(Perioperative period)
- Heart Rate(1.Prior to induction)
- Non Invasive Blood Pressure(1.Prior to induction)