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临床试验/NCT05632159
NCT05632159招募中不适用

Effect of Intraoperative Magnesium Sulphate on the Occurrence of Postoperative Delirium and Insomnia in Patients Undergoing Lumbar Fixation

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Insomnia

研究概览

简要总结

Anaesthesia-related complications and mortality have been significantly reduced in the last years.(1) Nevertheless, anaesthesia-related side effects, such as post-operative delirium and sleep disturbances should not be underestimated. These side effects are economically challenging because they may lead to prolonged hospital stay and change in lifestyle condition. (2) After general anesthesia' sleep disturbances frequently occur. They are featured by insomnia' hyperinsomnia' narcolepsy' and changed sleep structure. (3.4) There are a lot of risk factors associated with post-operative sleep disturbance such as patient age, preoperative comorbidity, severity of surgical trauma, postoperative pain, postoperative complications and presence of pre-operative fatigue and depression. (5) Insomnia is one of the most prevalent health problems during pre-operative period and after post-operative recovery. It can lead to increase incidence of post-operative complications such as delayed recovery , anxiety and delirium (6).

Post-operative delirium is also one of the most common complications following anaesthesia with frequency estimates ranging from 10 to 50%. It is defined as delirium occurring 24 to 72 hours after surgery. (7) There are multiple risk factors for developing postoperative delirium including pre-existing dementia, old age, medical co-morbidities, and psycopathological symptoms. The recognition and treatment of Post-operative delirium is critically important because postoperative delirium is associated with poor outcomes including functional decline, dementia, cognitive impairment, increased hospital length of stay , increased mortality ( 11% increasing in the risk of death at 3 months and up to a 17% increased risk of death at 1 year. (8)

Animal studies have found that Magnesium can regulate melatonin production which is a hormone that guide body sleep wake cycle (9) . Magnesium is an essential cofactor for many enzymatic reactions' especially those that are involved in energy metabolism and neurotransmitter synthesis. It is a cofactor involved in more than 300 enzyme systems' regulates diverse biochemical reactions in the body (10.11) .

Magnesium supplements were used to improve insomnia symptom among older people in a double blinded placebo controlled clinical trial(12). Low dietary Magnesium intake was found to be significantly associated with depression which is a potential risk factor for insomnia(13). Also using Magnesium sulphate as an adjuvant has been associated with significantly less analgesic requirements and reducing postoperative pain which can improve quality of sleep and decrease insomnia symptoms.(14)

AIM OF THE STUDY The aim of this work is to identify the potential predictors of postoperative delirium and insomnia in patients undergoing lumbar fixation under general anesthesia, and to evaluate the effect of intraoperative administration of Magnesium sulphate on the occurrence of post-operative delirium and insomnia in those patients.

详细描述

Study design and Participants:

This prospective randomized controlled trial will be carried out on 80 patients indicated for lumbar fixation. The selected patients will be randomly assigned to one of the following two groups; the first group will receive conventional general anaesthesia only (40 participants) (conventional anaesthesia group), and the second group will receive conventional general anaesthesia with extra administration of intraoperative magnesium sulphate (40 participants) (Mg sulphate group). Randomization will be carried out using a closed opaque envelope technique. The patients will be recruited from the Neurosurgery, Beni-Suef University Hospital, in the period from November, 2021 to May 2022.

Inclusion criteria:

  1. ASA I-II patients undergoing lumbar fixation.
  2. Male and female patients with age range between 20-70 years.

Exclusion criteria:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-II patients undergoing lumbar fixation.
  • Male and female patients with age range between 20-70 years.

排除标准

  • Patients having gross hemodynamic or ventilatory fluctuations during the operation.
  • Patients who develop postoperative shock, major bleeding or complication.
  • Patients with a history of chronic pain that may interfere with sleep
  • Patients with sleep apnea syndrome.
  • Patient with a history of neurodegenerative disease, concomitant medical or metabolic illness known to affect sleep (e.g., thyroid, chest or cardiac disorders).
  • Patients with a history of psychiatric disorders .
  • Patients with a current history of illicit drug use.
  • Patients using hypnotic, anxiolytic, or antipsychotic drugs .
  • Allergy to any of the drugs that will be used in the study.

研究组 & 干预措施

conventional anaesthesia group

Placebo Comparator

Induction of anesthesia will be done by injecting fentanyl 2 μg/kg, propofol1.5-2.5 mg/kg and atracurium 0.5 mg/kg for muscle relaxation.

干预措施: conventional anaesthesia (Drug)

Mg sulphate group

Active Comparator

Induction of anesthesia will be done by injecting fentanyl 2 μg/kg, propofol1.5-2.5 mg/kg and atracurium 0.5 mg/kg for muscle relaxation. With extra administration of intraoperative Magnesium sulphate 30 mg /kg as loading dose over 10 min then 10 mg /kg/ has maintenance dose

干预措施: Mg sulphate (Drug)

结局指标

主要结局

Insomnia

时间窗: 2 Weeks

Assessment of insomnia using Insomnia severity index

Postoperative delirium using Memorial delirium assessment scale (MDAS).

时间窗: 2 days

Assessment of postoperative delirium using Memorial delirium assessment scale (MDAS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Hussein

Associate professor of Neurology

Beni-Suef University

研究点 (1)

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