跳至主要内容
临床试验/CTRI/2024/09/074356
CTRI/2024/09/074356尚未招募4 期

Comparison of Magnesium Sulfate and Tranexamic Acid on the Clarity of Vision During Arthroscopic Rotator Cuff Repair.

Kasturba Medical College, Manipal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Achievement of Grade 4 or 5 of vision during arthroscopy

研究概览

简要总结

This randomized controlled trial (RCT) aims to compare the efficacy of magnesium sulphate and tranexamic acid in improving surgical field clarity during arthroscopic rotator cuff repair. Arthroscopic surgeries require optimal visualization of anatomical structures to ensure precise and successful interventions. However, bleeding during surgery can impair visual clarity, leading to longer operative times and increased risk of complications. To address this issue, controlled hypotension is often induced during surgeries, which can be achieved using different pharmacological agents. While tranexamic acid is well-known for reducing blood loss by inhibiting fibrinolysis, the use of magnesium sulphate in this context is less established. This study aims to fill this gap in the literature by investigating the comparative efficacy of both drugs in arthroscopic surgeries.

The trial will involve 60 patients, aged 18 to 60 years, all of whom are scheduled for elective arthroscopic rotator cuff repair and have an American Society of Anesthesiologists (ASA) physical status of I or II. Patients will be randomly allocated into one of three groups using a computer-generated randomization table: Group M (Magnesium Sulphate), Group T (Tranexamic Acid), and Group C (Control). Group M will receive 2g of magnesium sulphate in 100ml of normal saline, Group T will receive 1g of tranexamic acid in 100ml of normal saline, and Group C will receive 100ml of normal saline alone. The drugs will be administered intravenously over 20 minutes, and the surgeon and anesthesiologist will be blinded to the group allocation.

The inclusion criteria for the study are adult patients with a confirmed diagnosis of rotator cuff tear, scheduled for arthroscopic rotator cuff repair, and willing to provide informed consent. Exclusion criteria include known allergies to magnesium sulphate or tranexamic acid, renal impairment, pre-existing coagulopathy or bleeding disorders, pregnancy, uncontrolled hypertension, and participation in other clinical trials.

The primary objective of the study is to achieve a surgical field clarity grade of 4 or 5 during the arthroscopic procedure, as assessed by the operating surgeon using a validated grading scale. This scale ranges from 1 to 4, with grade 1 representing clear visualization of all anatomical structures and grade 4 representing poor visibility. Secondary objectives include evaluating hemodynamic changes during surgery, such as heart rate, systolic, diastolic, and mean blood pressure, as well as the minimum alveolar concentration (MAC) of inhaled anesthetics at baseline and at regular intervals during surgery. Other secondary outcomes include time to extubation, postoperative sedation score (using the Ramsay sedation scale) at one hour post-extubation, postoperative pain score (assessed by a visual analogue scale), and the time to the first request for analgesia.

his study will provide valuable insights into the comparative effectiveness of magnesium sulphate and tranexamic acid in reducing intraoperative bleeding and improving surgical visibility. Both agents have distinct mechanisms of action: magnesium sulphate induces controlled hypotension by acting as a calcium channel blocker, while tranexamic acid reduces bleeding by inhibiting fibrinolysis. By comparing these two drugs in the specific setting of arthroscopic rotator cuff repair, the study aims to identify which agent offers superior clarity of vision, thereby improving surgical outcomes and potentially shortening operative time.

Furthermore, this study is particularly important given the scarcity of literature on the use of magnesium sulphate in arthroscopic surgeries. Tranexamic acid has been more extensively studied in orthopedic surgeries, but its role in shoulder arthroscopy is still being evaluated. By filling this gap, the trial aims to contribute valuable data that may guide future clinical practices in perioperative management, particularly in surgeries requiring optimal visualization.

In conclusion, this RCT will assess the effectiveness of magnesium sulphate and tranexamic acid in enhancing surgical visibility during arthroscopic rotator cuff repair. The findings may help refine perioperative strategies, leading to improved patient outcomes in arthroscopic procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor 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

  • Adult patients aged 18 to 60 years scheduled for arthroscopic rotator cuff repair.
  • Patients with a diagnosis of rotator cuff tear confirmed by imaging studies (MRI, ultrasound).
  • ASA (American Society of Anesthesiologists) physical status I or II.
  • Willingness to provide informed consent for participation in the study.

排除标准

  • Participants with a known allergy or hypersensitivity to magnesium sulfate or tranexamic acid, history of renal impairment or significant renal disease, pre-existing coagulopathy or bleeding disorders, pregnancy or lactation in female patients, and a history of seizures or epilepsy. Additionally, patients on anticoagulant medications within two weeks prior to surgery, those with uncontrolled hypertension.
  • systolic BP more than 160 mmHg or diastolic BP more than 100 mmHg, individuals enrolled in another clinical trial, and patients unable to communicate effectively or comprehend the study requirements will also be excluded.

结局指标

主要结局

Achievement of Grade 4 or 5 of vision during arthroscopy

时间窗: 15 min, 30 minutes after the comparator agent is given.

次要结局

  • Haemodynamic changes during surgery (heart rate, systolic, diastolic and mean blood pressure(at baseline and every five minutes of surgery, till five min after extubation. He/she will also note)
  • Time to extubation of the patient after cutting off anaesthetics.(Postoperative sedation score (Ramsay sedation scale) at one hour after extubation)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Maneesh Kumar

Kasturba Medical College, Manipal

研究点 (1)

Loading locations...

相似试验