Reduction in bleeding in middle ear surgeries with target control infusion with propofol, and comparison with dexmedetomidine and fentanyl fixed dose

TARGET CONTROLLED INFUSION WITH PROPOFOL IN MIDDLE EAR SURGERIES -A RANDOMISED CONTROLLED DOUBLE-BLIND TRIAL ON REDUCTION IN SURGICAL BLEEDING WITH FIXED DOSE INTRAVENOUS INFUSION OF FENTANYL OR DEXMEDETOMIDINEâ??

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049466

Enrollment

Registered

2023-02-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Fixed dose intravenous infusion of dexmedetomidine: Inj. Dexmedetomidine is started with bolus 1mcg/kg and followed by infusion (0.5mcg/kg/hr) before activation of proof old administrat

Eligibility

Inclusion criteria

Inclusion criteria: 1.All patients undergoing middle year surgeries of 18-60 years of age. 2.American society of anaesthesiologists physical status I and II 3. Non obese (BMI- 18.5-29.9)

Exclusion criteria

Exclusion criteria: 1.Refusal of patients consent 2.Patients with significant systemic disease 3.Patients on long term and concurrent sedative intake

Design outcomes

Primary

Measure	Time frame
Reduction in surgical bleedingTimepoint: Reduction in surgical bleeding 1) post intubation (every 5 min) 2) following 24 hours after surgery	—

Secondary

Measure	Time frame
changes in systolic BP, diastolic BP, mean BP, heart rate, SP02, EtCO2. Total propofol used. Correlation of TCI propofol with the state entropy levels. Incidence of postoperative nausea and vomiting. Timepoint: pre induction intubation post intubation every 5 min intraoperative	—

Countries

India

Contacts

Public ContactReethesh s moorman

Vijayanagar Institute of medical sciences

sbalabhaskar@gmail.com9880012349

Outcome results

None listed

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