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A Study to compare anesthesia drug in controlling blood loss in patient undergoing vertebral spine surgery

The Effect of Remifentanil Induced Controlled Hypotension Versus Tranexamic Acid on Perioperative Blood Loss in Spine Surgery A Randomized Controlled Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104626
Enrollment
80
Registered
2026-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: M488- Other specified spondylopathies Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Remifentanil: Remifentanil infusion at 0.1 g/kg/hr IV to maintain MAP 60 65 mmHg during surgery and for 6 hours postoperatively. Intervention2: Tranexamic Acid: Tranexamic Acid loading

Sponsors

V. M. Vishaal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 to 65 years 2. ASA Physical Status 1,2,3 3. Scheduled for elective posterior lumbar spine instrumental surgery 4. Willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Coagulopathy or bleeding disorders 2. Use of anticoagulant or antiplatelet drugs within 7 days 3. Allergy to Remifentanil or Tranexamic Acid 4. History of thromboembolic events in the past 6 months 5. Significant hepatic, renal, or cardiovascular disease 6. Patients on chronic opioid therapy 7. Pregnant or breastfeeding women 8. Unwilling to provide consent

Design outcomes

Primary

MeasureTime frame
Total perioperative blood loss (suction volume + gauze weight + postoperative drain output)Timepoint: At 24 hours after surgery

Secondary

MeasureTime frame
C-reactive protein (CRP) levelsTimepoint: Preoperative (baseline), 24 hours postoperative, and 72 hours postoperative;Hemoglobin difference (preoperative vs 24 hours postoperative)Timepoint: Baseline and 24 hours postoperative;Surgical field visibility using Fromme Boezaart grading scaleTimepoint: Intraoperative period;Number and volume of blood transfusionsTimepoint: Intraoperative and first 24 hours postoperative;Adverse events (hypotension, bradycardia, thromboembolism)Timepoint: Intraoperative, 24 hours postoperative, and 72 hours postoperative

Countries

India

Contacts

Public ContactDr G Mirunalini

SRM Medical College Hospital and Research Centre

mirunalg@srmist.edu.in9486131643

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026