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.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074356

Enrollment

Registered

2024-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S460- Injury of muscle(s) and tendon(s)of the rotator cuff of shoulder

Interventions

Intervention1: 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. Control Intervention1: Group T - Tra

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Achievement of Grade 4 or 5 of vision during arthroscopyTimepoint: 15 min, 30 minutes after the comparator agent is given.	—

Secondary

Measure	Time frame
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.Timepoint: 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 analgesiaTimepoint: 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.	—

Measure

Time frame

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.Timepoint: 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 analgesiaTimepoint: 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.

—

Countries

India

Contacts

Public ContactDr Sushma H

Kasturba Medical College, Manipal

anitharshenoy@gmail.com9880842121

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026