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

Not Applicable

Recruiting

• Conditions: patients undergoing surgery which require general anaesthesia

• Registration Number: CTRI/2017/07/008962
• Lead Sponsor: Department of Anaesthesiology

Brief Summary

After institutional review board approval (IRB No. 522/2015) and written informed consent from patient, this prospective randomized double-blinded clinical trialis being carried out in 100 patients.After thorough preanaesthetic evaluation patients ar eallocated into two groups according to inclusion and exclusion criteria.Patients are randomized to one of the two groups of 50 patients each by sealed envelope method

Group I  (n=50)  - 0.3 mg/kg of nalbuphine diluted up to 10 ml, intravenously 10 minutes before induction

Group II (n=50) - 3 µg/kg of fentanyl diluted up to 10ml,intravenously  10 minutes before induction

       

Monitoring for HR, NIBP (SB, DBP and MAP) and peripheral oxygen saturation (spo2) will be established and baseline vital parameters will be recorded   and baseline sedation will be graded as per ramsay sedation score .In preanaesthetic preparation room, peripheral intravenous line will be secured with   20G venous cannula.All patients will receive pre medications with ondansetron 0.08 mg/kg Intravenously and glycopyrrolate 0.004 mg/kg Intravenously    15 minutes before induction.



All patients will receive  a standard prescribed anaesthetic protocol. After pre oxygenation with 100% oxygen for 3 minutes with facemask, anaesthesia will be induced with 2.5% thiopentone sodium intravenously slowly till loss of eyelash reflex. Following check ventilation, muscle paralysis will be achieved by succinylcholine 2 mg/kg intravenously. When there was no response to Train of Four on peripheral nerve stimulation (ulnar nerve at wrist), trachea will be intubated with sterile polyvinyl chloride, cuffed, disposable endotracheal tube (sized 7 to7.5mm for female and 8.5 to 9 mm for male). The intubating anaesthesiologist will be blinded with the nature of study. Tube will be attached to Bain’s breathing system . IPPV will be started.



After confirming successful intubation with end tidal clinical examination, anaesthesia will be maintained with  O2 and N2O (50:50), vecuronium bromide and inhalational agent of choice. Tidal volume and ventilatory frequency will be adjusted so as to maintain  normocapnia  (end tidal CO2 40 ± 4 mmHg).

      

At the end of surgery, neuromuscular blockade will reversed with neostigmine 0.05mg/ kg and glycopyrolate 0.08mg/ kg intravenously. After satisfying the extubation criteria trachea will extubated and patients will be  transfer to post anaesthesia care unit.

   

Readings of HR, SBP, DBP and MAP were recorded – preoperatively, immediately after study drug administration at 2min,5min, immediately after intubation, at 1min, 3min, 5min, 15min and 30min after successful intubation.



Complication during the course of the study if any like bradycardia, hypertension, hypotension, respiratory depression, cardiac arrhythmia will be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-23
• Last Update Posted: 2017-06-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy and safety of nalbuphine and fentanyl in	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
haemodynamic stress response to laryngoscopy and endotracheal	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
intubation.	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
attenuating	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 Outcome Measures

Name	Time	Method
To assess the sedative effect of nalbuphine and fentanyl	To observe complication if any, in two groups.

Trial Locations

Locations (1)

Sir.T.Hospital ,Bhavnagar; 🇮🇳 Bhavnagar, GUJARAT, India

Sir.T.Hospital ,Bhavnagar

🇮🇳Bhavnagar, GUJARAT, India

Bhargav Fadadu

Principal investigator

9662040034

dr.bfadadu@gmail.com