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A clinical trial to study of analgesic and hemodynamic effect of nalbuphine vs fentanyl, a randomized double blind Interventional Study On Cardiac Surgical Patients

Comparison of analgesic and hemodynamic effect of nalbuphine vs fentanyl :A randomized double blind Interventional Study on cardiac surgical patients at SMS medical college and attached hospitals, Jaipur during 2018-2019

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021537
Enrollment
60
Registered
2019-10-07
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: I39- Endocarditis and heart valve disorders in diseases classified elsewhere

Interventions

Intervention1: iv inj nalbuphine: 30 patients will receive inj. nalbuphine 0.2mg/kg iv slowly 5 minutes before induction and thereafter repeated if BIS SCORE more than 60 during surgery. Interventi

Sponsors

Department of anesthesiologySMS medical college jaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Either sex 2. Age group 18-65yrs 3 .Body weight 40-70kg 4. ASA Grade II &lll 5. Scheduled for cardiac surgery on cardiopulmonary bypass

Exclusion criteria

Exclusion criteria: 1. Patients not willing to participate in study 2. Uncooperative patients 3. Patients with history of drug allergy 4. Patients with pre-existing, Asthma, Renal or Hepatic dysfunction 5. Morbid obese patient 6. Pregnancy/Lactation

Design outcomes

Primary

MeasureTime frame
To assess and compare hemodynamic variables from baseline at different time interval in both groups. Heart rate Systolic blood pressure Diastolic blood pressure Mean Arterial Pressure central venous pressure Timepoint: Data will be recorded baseline (before induction), just after intubation, 5 min and 15 min, 30 min after intubation nd after that 5 min before going on pump, 5 min after going on pump, every 30 min till shifted to icu.

Secondary

MeasureTime frame
1.To asses and compare BIS guided total requirement of analgesic drug in bothgroups 2.To assess and compare the time required for first rescue analgesic in both group in postoperative period after extubation according to VAS score. 3.To compare side effects and complications of both drugs. Timepoint: After extubation ,post operative analgesia evaluted by visual analogue scale (VAS)in every 30 mins till vas more then 3

Countries

India

Contacts

Public ContactDR SAURABH KUMAR SHARMA

sms medical college jaipur

dranjumsaiyed@gmail.com9214021930

Outcome results

None listed

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