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Comparison of two drugs combinations Propofol- Nalbuphine and Propofol- Fentanyl in induction for Total Intravenous Anaesthesia in operations.

Comparison of Propofol- Nalbuphine and Propofol- Fentanyl induction combinations in Total Intravenous Anaesthesia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019159
Enrollment
100
Registered
2019-05-15
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: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: Combination of Propofol-Nalbuphine and propofol -Fentanyl: Group -1 will receive Inj. Nalbuphine 0.2mg/Kg IV and group-2 will receive Inj. Fentanyl 2μg/Kg Body weight IV, 5 min before

Sponsors

Peoples College of Medical Sciences RC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Total 100 adult patients between age group of 30 to 65 years belonging to ASA I and II of either sex under- going surgical procedures up to 90 min duration will be included in the study.The patients will be divided into two groups of 50 patients each. Patients taken for procedure at odd serial no. 1,3,5... of 100 patients (Group 1) will receive Nalbuphine 0.2mg/Kg body weight IV and patients taken for surgery at even serial no. 2,4,6 of 100 patients ..(Group 2) will receive Inj. Fentanyl 2μg/Kg body weight IV 5 min before induction.Maintenance of Anaesthesia will be done with infusion of I/V Propofol 10 mg/kg/hour for 10 min, 08mg/kg/hour for next 10 min and 06 mg/Kg/hour for remaining duration. Supplemental dose of 25 mg of Propofol will be given during surgical procedure if required. Inj. Vecuronium 0.015 mg/Kg Body weight will be given every 20 to 40 min. All the patients will be ventilated with O2 and N2O with controlled ventilation and breathing circuit attached to circle absorber.At the end of surgerical procedure residual neuro-muscular paralysis will be reversed with Inj. Neostigmine 0.05mg/kg body Wt. and Inj. Glycopyrolate 0.008mg/kg body Wt. intravenously. Sedation characteristics will be noted. The patients will be observed in post operative period for any symptom and sign. The vital parameters will also be observed.

Exclusion criteria

Exclusion criteria: The patients with previous history of hypersensitivity to any of study drug, allergy to egg or fat, on long term Phenothiazines and MAO Inhibitors, anticipated difficult intubation, patients with significant systemic diseases like cardiovascular, renal, hepatic diseases, H/O Bronchial asthma and other respiratory diseases, Alcohol abuse, H/O seizure disorders, thyroid disease, neurological disorders, H/O opium addiction, recent H/O head injury, pregnant women , patients of ASA III and above and patients who will not give consent will also be excluded

Design outcomes

Primary

MeasureTime frame
Group 1 will receive Inj. Nalbuphine 0.2mg/Kg IV and group-2 Inj. Fentanyl 2μg/Kg Body weight 5 min before induction with Propofol 2mg/kg body weight Inj. vecuronium 0.1 mg/kg bag mask ventilation. Endotracheal tube inserted. Maitenance with Oxygen- Nitrous Oxide I/V Propofol. Vecuronium 0.015 mg/Kg Body weight given every 20 to 40 min. Will be reversed with Neostigmine and Glycopyrolate.Timepoint: Side effects if any with the combinations. Change in vital parameters during procedures and in immediate post operative period were noted

Secondary

MeasureTime frame
At the end of surgery residual neuro-muscular paralysis will be reversed with Inj. Neostigmine 0.05mg/kg body Wt. and Inj. Glycopyrolate 0.008mg/kg body Wt. intravenously and patients will be extubated.Timepoint: Patients will be observed in recovery room for any post operative signs and symptoms like nausea, vomiting, hypotension, bradycardia, respiratory depression, agitation and arrhythmias etc. The treatment if required will be given.

Countries

India

Contacts

Public ContactKANHAIYA LAL KISHNANI

Peoples college of Medical Sciences & Research Center By-pass road Bhanpur Bhopal

drkishnani@gmail.com0755-4004010

Outcome results

None listed

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