Skip to content

to compare the effect of nalbuphine vs fentanyl for haemodynamic stability in general anaesthesia.

â??A CLINICAL EVALUATION OF EFFICACY AND SAFETY OF NALBUPHINE AND FENTANYL TO PREVENT HAEMODYNAMIC STRESS RESPONSE DURING LARYNGOSCOPY AND INTUBATION :A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP CLINICAL TRIAL"

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/008962
Enrollment
100
Registered
2017-07-04
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- patients undergoing surgery which require general anaesthesia

Interventions

Intervention1: 0.3 mg/kg of nalbuphine : 0.3 mg/kg of nalbuphine diluted up to 10 ml, intravenously 10 minutes before induction Control Intervention1: 3 µg/kg of fentanyl: 3 µg/kg of fentanyl dilu

Sponsors

Department of Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Informed written consent for participation in study Age: 20 to 60 years. Either gender ASA physical status I and II. Patients posted for elective surgery for 2 hour duration, under general anaesthesia, requiring endotracheal intubation.

Exclusion criteria

Exclusion criteria: Patient refusal to participate in study. Hypersensitivity to drug. Patients with anticipated difficult airway. Patient with cardiac, pulmonary, neurologic, kidney diseases. Patients on drugs like sedatives, opioids and anti-psychiatric drugs. Intubation attempt lasting longer than 20 seconds.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy and safety of nalbuphine and fentanyl in attenuating haemodynamic stress response to laryngoscopy and endotracheal intubation. Timepoint: base line,study drug injection,2min,5min,10min,during laryngoscopy and intubation,1min,3min,5min,10min,15min,20min,30min,45min,60min,90min,120min,after extubation

Secondary

MeasureTime frame
To assess the sedative effect of nalbuphine and fentanyl To observe complication if any, in two groups.Timepoint: base line,study drug injection,2min,5min,10min,during laryngoscopy and intubation,1min,3min,5min,10min,15min,20min,30min,45min,60min,90min,120min,after extubation

Countries

India

Contacts

Public ContactDr Komal Shah

Govt Medical College Bhavnagar

shah.Komal@rediff.com09427215252

Outcome results

None listed

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