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A study comparing opioid free and opioid based anaesthesia on intraoperative blood loss and recovery profile after transsphenoidal resection of pituitary tumors

A comparative study of opioid free and opioid based anaesthesia on intraoperative blood loss and recovery profile after transsphenoidal resection of pituitary tumors- a randomised controlled double-blinded trial - nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099236
Enrollment
36
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: D352- Benign neoplasm of pituitary gland

Interventions

Intervention1: OFA Group: Dexmedetomidine (6 mcg/ml) Bolus (1 g/kg) over 10 mins followed by maintenance infusion (0.3 0.7 g/kg/h) till tumor excision : Adjust Concentration 6 mL/hr for all patien

Sponsors

Abhishek kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II patients undergoing elective TNTS pituitary tumor resection Age 18 to 65 years BMI 18 to 30 kg per meter square

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years or more than 65 years 2. ASA Physical Status IV or above 3. Known allergy or hypersensitivity to any study drugs (e.g., ketamine, lidocaine, dexmedetomidine, fentanyl, propofol, etc.) 4. Patients with pre-existing severe cardiac disease (e.g., unstable angina, recent MI, EF less than 35 percent, Bradyarrythmias, Tachyarrythmias) 5. Patients with significant hepatic or renal dysfunction (LFTs more than 3 normal, serum creatinine more than 2.0 mg/dL) 6. History of chronic opioid use or opioid dependence 7. Preoperative altered mental status (GCS less than 15) 8. Presence of neurological deficits precluding accurate postoperative assessment 9. Patients on antipsychotic or sedative medications 10. Known history of seizure disorder or psychiatric illness 11. Pregnant or lactating women 12. Patients with BMI more than 35 kg/m 13. Refusal to provide informed consent

Design outcomes

Primary

MeasureTime frame
There is no significant difference in intraoperative blood loss or postoperative recovery profile between opioid-free and opioid-based anaesthesia in TNTS surgery. or Opioid-free anaesthesia results in reduced intraoperative blood loss and improved recovery profile compared to opioid-based anaesthesia in TNTS surgery. Timepoint: 4hrs and 6 hrs and 12 hrs

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactAjit Bhardwaj

Armed Forces Medical College,Pune

rainaajit@gmail.com8171505533

Outcome results

None listed

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