Comparison of Dexmedetomidine and Sevoflurane on the quality of recovery and cognitive function after general anaesthesia: A Randomised Single Blinded clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison of Dexmedetomidine and Sevoflurane on QoR-15(Quality of recovery questionnaire)
研究概览
简要总结
Surgical and anaesthetic procedures may affect a patient’s quality of life, producing a sensation of discomfort, even in the absence of specific complications. In addition, poor postoperative recovery may lead to increased hospital costs and decreased patient satisfaction. Therefore, anaesthesiologists seek techniques that can provide high-quality recovery, minimise the complications, and reduce the time to return to daily activities. The two most commonly used general anaesthesia techniques are total intravenous anaesthesia (TIVA) and balanced general anaesthesia (BGA), with intravenous anaesthesia combined with inhalation anaesthesia. The use of total intravenous anaesthesia (TIVA) has increased recently; this technique has been reported to provide a better experience and higher levels of patient satisfaction in outpatient and inpatient surgeries, possibly because of a lower incidence of pain, agitation, and postoperative nausea and vomiting (PONV). Studies on the quality of postoperative recovery have mainly focused on measures such as recovery time, cardiorespiratory complications, pain, postoperative nausea and vomiting (PONV), hospital length of stay and other complications. Considered in isolation, these factors may be insufficient to explain a patient’s perception of postoperative recovery following general anaesthesia. However, patient-assessed quality of life is an important factor to be considered in this clinical setting.Sevoflurane, a volatile inhalation anaesthetic, is widely utilised in surgical procedures due to its favourable pharmacokinetics. While it provides a reliable depth of anaesthesia, its rapid elimination allows for a relatively prompt recovery. However, concerns have been raised regarding emergence delirium and potential cognitive effects associated with sevoflurane, particularly in vulnerable patient populations.
Postoperative cognitive dysfunction (POCD)poses a significant challenge in the realm of general anaesthesia and surgery, particularly affecting patients. This cognitive decline, encompassing memory, mood, and sleep disturbances, presents clinical complexities with repercussions such as prolonged hospitalisation and increased mortality. Although different drugs including opioids, benzodiazepines and clonidine, one kind of alpha 2-adrenoreceptor agonists, have been tried in clinic either as alpha prophylactic measure or treatment, the results have been variable.Among which, dexmedetomidine, a highly specific alpha2-adrenoreceptor agonist (receptor selectivity, alpha 2 / alpha 1 = 1620/1), has sedative and analgesic properties without significant respiratory depression at the clinically approved dosage. Dexmedetomidine emerges as a multifunctional candidate with reported neuroprotective effects. While clinical studies suggest potential benefits, a comprehensive understanding remains elusive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Adult subjects classified as American Society of Anaesthesiologists (ASA) I-II.2.Non-obese individuals with a body mass index (BMI) below 30kg/m2.3.Mini-Mental State Examination(MMSE) score 25 preoperatively.4.Patients undergoing general anaesthesia of more than 2 hours and less than 6 hours at UPUMS hospital.
排除标准
- •1.Patient refusal.
- •2.Presence of health conditions(e.g.cardiac, pregnancy, pulmonary diseases,neurological condition) 3.Visual/hearing impairment, smoking/alcohol abuse, cognitive dysfunction.
- •4.Mini-Mental State Examination (MMSE) score less than 25 preoperatively.
- •5.Any known allergy to drugs.
结局指标
主要结局
Comparison of Dexmedetomidine and Sevoflurane on QoR-15(Quality of recovery questionnaire)
时间窗: Preoperatively (30 min before surgery) | Post-operative Day-1 | Post-operative Day -2 | At the day of discharge
次要结局
- 1.Comparison of Dexmedetomidine and Sevoflurane on MMSE(Mini mental state examination)(2.Comparison of hemodynamic parameters)
研究者
Dr Mamta Kushwaha
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES
