| CTRI Number |
CTRI/2024/09/074356 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This study aims to compare the effects of Magnesium sulfate and Tranexamic acid, on improving the clarity of the surgeons vision during arthroscopic rotator cuff repair surgery. |
|
Scientific Title of Study
|
Comparison of Magnesium Sulfate and Tranexamic Acid on the Clarity of Vision During Arthroscopic Rotator Cuff Repair. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maneesh Kumar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi Tiger Circle, Madhav Nagar, Eshwar Nagar, Manipal Udupi KARNATAKA 576104 India |
| Phone |
9474269506 |
| Fax |
|
| Email |
kmaneesh1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anitha Nileshwar |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi Tiger Circle, Madhav Nagar, Eshwar Nagar, Manipal Udupi KARNATAKA 576104 India |
| Phone |
9880842121 |
| Fax |
|
| Email |
anitharshenoy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sushma H |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi Tiger Circle, Madhav Nagar, Eshwar Nagar, Manipal Udupi KARNATAKA 576104 India |
| Phone |
9483305224 |
| Fax |
|
| Email |
sushmahaithal237@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal |
| Address |
Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maneesh Kumar |
Kasturba Medical College, Manipal |
Department of Anaesthesiology, Main OT complex, Kasturba Medical College and Hospital, Manipal - 576104 Udupi KARNATAKA |
9474269506
kmaneesh1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S460||Injury of muscle(s) and tendon(s)of the rotator cuff of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C - Normal Saline (Control group) |
Control Group - 100 ml Normal Saline (0.9%) IV over 20 minutes, once during the surgery. |
| Intervention |
Group M - Magnesium Sulphate |
Magnesium Sulphate 2g IV (30-50 mg/kg maximum 2g) in 100 ml NS over 20 minutes, will be given once during the surgery. |
| Comparator Agent |
Group T - Tranexamic Acid |
Tranexamic Acid 1 g IV (10-15 mg/kg maximum 1g) in 100 ml NS over 20 minutes, will be given once during the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18 to 60 years scheduled for arthroscopic rotator cuff repair.
2. Patients with a diagnosis of rotator cuff tear confirmed by imaging studies (MRI, ultrasound).
3. ASA (American Society of Anesthesiologists) physical status I or II.
4. Willingness to provide informed consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Achievement of Grade 4 or 5 of vision during arthroscopy |
15 min, 30 minutes after the comparator agent is given. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
down the minimum alveolar concentration (MAC) of inhaled anaesthetic during the intraoperative
phase. |
Every 5 minutes after intubation till the surgery ends. |
Time to extubation of the patient after cutting off anaesthetics.
Postoperative sedation score (Ramsay sedation scale) at one hour after extubation
Postoperative pain score at one hour after extubation
Time to first request for analgesia |
Extubation time will be noted when the tube is out.
Postoperative sedation and pain score - 1 hour after extubation.
Time to first request for analgesia after extubation will be noted. |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |