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A study comparing the effects of two drugs, Dexmedetomidine and Fentanyl, on the blood pressure and heart rate in patients with high blood pressure, undergoing major surgery

Comparison of Dexmedetomidine with Fentanyl for maintenance of intra-operative hemodynamics in hypertensive patients undergoing major surgery - A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003513
Enrollment
60
Registered
2013-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Hypertensive American Society of Anesthesiologists (ASA) 2 physical status

Interventions

Intervention1: Dexmedetomidine (selective alpha-2 agonist): Loaded as a 2mcg/ml solution in 50ml NS. Loading dose 1mcg/kg infusion given over 10 minutes intravenously. Changed over to maintenance dose

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Hypertensive patients under American Society of Anesthesiologists (ASA) Physical status 2 posted for major surgery under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Systolic BP > 160mmHg, Diastolic BP >100mmHg 2. H/o ischemic heart disease 3. H/o cerebral vascular disease 4. Impaired renal function tests 4. Impaired liver function tests 5. Laparoscopic procedure 6. Pregnant and suspected full-stomach patients 7. Anticipated difficult airway 8. Surgery with expected significant blood loss ( >25%of blood volume) and fluid shifts

Design outcomes

Primary

MeasureTime frame
To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous FentanylTimepoint: To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous Fentanyl

Secondary

MeasureTime frame
Opioid consumption Timepoint: Intra operative ;Time to recover from anesthesia (eye opening to verbal call)Timepoint: End operative;Time to first analgesic requestTimepoint: Post operative

Countries

India

Contacts

Public ContactKanchan V Bilgi

JIPMER

jipmervasu@gmail.com9894444102

Outcome results

None listed

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