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

Phase 4

Recruiting

• Conditions: HypertensiveAmerican Society of Anesthesiologists (ASA) 2 physical status

• Registration Number: CTRI/2013/03/003513
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

Brief Summary

Hypertensive patients are known to have labile hemodynamics in the intra operative period. Post operative complications like myocardial infractions, arrhythmia, congestive cardiac failure, stroke and renal failure are more likely in the presence of intra operative hemodynamic instability.

Opioids like Fentanyl and Morphine are used extensively, in view of their established sedative and analgesic properties. Their significant side effects include respiratory depression, post-operative nausea and vomiting, and urinary retention.

In this study, the aim is to compare the effects of Dexmedetomidine, a highly selective Alpha-2 agonist, with those of Fentanyl on intraoperative hemodynamics,, opioid consumption, time to recovery and duration of post operative analgesia.



The study hypothesis is that Dexmedetomidine provides better hemodynamic stability intra operatively, when compared with fentanyl, while avoiding the side effects of opioids.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-15
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Systolic BP> 160mmHg, Diastolic BP>100mmHg 2.
• H/o ischemic heart disease 3.
• H/o cerebral vascular disease 4.
• Impaired renal function tests 4.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous Fentanyl	To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous Fentanyl

Secondary Outcome Measures

Name	Time	Method
Opioid consumption
Time to recover from anesthesia (eye opening to verbal call)	End operative
Time to first analgesic request	Post operative

Trial Locations

Locations (1)

JIPMER Hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

JIPMER Hospital

🇮🇳Pondicherry, PONDICHERRY, India

Kanchan V Bilgi

Principal investigator

8526617221

kanchanbilgi@gmail.com