Magnesium Sulfate Versus Dexmedetomidine on Anesthesia Awakening. Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to awake from anesthesia between groups
研究概览
简要总结
Magnesium sulfate (MS) and dexmedetomidine have already demonstrated the ability to reduce intra and postoperative consumption of anesthetics and analgesics, among others advantages, such as blood pressure control and intraoperative bleeding. The MS has also been shown to be useful in pre-eclampsia and eclampsia control, pulmonary hypertension, asthma, cardiac arrhythmias and pheochromocytoma). Despite these advantages in the use of these important adjuncts, there is a concern about the quality and awakening time of the patients who use them. The purpose of this trial is to compare the time and quality of awakening in patients submitted to general anesthesia and receiving MS or dexmedetomidine as adjuncts in the intraoperative analgesia.
The main objective of this trial is to compare the quality and the awakening time in patients receiving MS or dexmedetomidine. The secondary objective is the comparison of postoperative analgesia in the postoperative hospitalization period. Hypothesis: Our hypothesis is that patients present a faster awakening when receive MS as an analgesic adjunct, when compared to patients who receive dexmedetomidine. Drawing: this is a prospective, controlled, covert trial with random distribution for noninferiority trialing.
详细描述
INTRODUCTION Magnesium sulfate (MS) and dexmedetomidine have already demonstrated the ability to reduce intra and postoperative consumption of anesthetics and analgesics, among others advantages, such as blood pressure control and intraoperative bleeding8,9. The MS has also been shown to be useful in pre-eclampsia and eclampsia control, pulmonary hypertension, asthma, cardiac arrhythmias and pheochromocytoma). Despite these advantages in the use of these important adjuncts, there is a concern about the quality and awakening time of the patients who use them. The purpose of this trial is to compare the time and quality of awakening in patients submitted to general anesthesia and receiving MS or dexmedetomidine as adjuncts in the intraoperative analgesia.
The main objective of this trial is to compare the quality and the awakening time in patients receiving MS or dexmedetomidine. The secondary objective is the comparison of postoperative analgesia in the postoperative hospitalization period. Our hypothesis is that patients present a faster awakening when receive MS an analgesic adjunct, when compared to patients who receive dexmedetomidine.
Drawing: this is a prospective, controlled, covert trial with random distribution for noninferiority trialing.
Key words: general anesthesia, long awakening from anesthesia. METHODS Participants and endpoints Scenario: The study will be carried out at "Hospital da Sociedade Portuguesa de Beneficência de Santos - Angiocorpore" (Portuguese Charity Society Hospital). Eligibility: Patients scheduled for video laparoscopic cholecystectomy, between 18 and 70 years old, physical status I or II in the American Society of Anesthesiology classification, who have no allergy or contraindication to the study protocol substances and who voluntarily agree to participate in the trial and sign the informed consent form (TCLE), will be invited to participate in the study.
Coronary disease patients, patients with heart block > atrioventricular block > I, patients with renal failure, those with brain disease past history, dementia or other psychiatric diseases, and patients with body mass index > 35 kg/m², will be excluded. Also excluded patients with Portuguese language limitations and in preoperative use of opioid or corticosteroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
One professional of the team of providers will be responsible for conducting the electronic drawing on the website www.random.org, to distribute 90 numbers randomly into three groups. By following the results he or she will identify 90 opaque envelopes with numbers, and inside of each envelope will be a card with the name of corresponding group and the instructions about the corresponding intervention. This professional will not take part in any other part of the investigation. Every other professionals of the team and the patient will be blinded to group to which the patient belong. Each of the invited patient who accepts to participate and sign the consent form in the pre-anesthetic consultation, will receive the sequential envelope and be part of the corresponding group. At the arrival in the surgical center, one particular professional of the team will open the envelope and prepare the blinded solution, that will still be unclosed to any other people in the trial.
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for video laparoscopic cholecystectomy, between 18 and 70 years old, physical status I ou II in the American Society of Anesthesiology classification
排除标准
- •Allergy or contraindication to the study protocol substances, refuse to participate or sign the informed consent, heart block > atrioventricular I, renal failure, brain disease, dementia or other psychiatric diseases, body mass index > 35 kg/m², Portuguese language limitations, preoperative use of opioid or corticosteroids.
研究组 & 干预措施
Placebo group
Thirty patients in this group will receive infusion of 100 saline solution. After 15 min of beginning of this infusion they will start receiving general anesthesia administration.
干预措施: Sham treatment (Drug)
Dexmedetomidine group
Thirty patients in this group will receive infusion of dexmedetomidine (0,5 mcg/kg/min). After 15 min of the beginning of this infusion they will start in the general anesthesia induction.
干预措施: Dexmedetomidine (Drug)
Magnesium sulfate group
Thirty patients in this group will receive infusion of magnesium sulfate (20 mg/kg/h). After 15 min of the beginning of this infusion they will start in the general anesthesia induction.
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Time to awake from anesthesia between groups
时间窗: Three hours
Comparing time in minutes to get bispectral index higher than 60 in both groups
次要结局
- Comparing postoperative analgesia between groups(Two days)
研究者
Joaquim Edson Vieira
Associate professor
University of Sao Paulo General Hospital
