| CTRI Number |
CTRI/2017/07/008962 [Registered on: 04/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare the effect of nalbuphine vs fentanyl for haemodynamic stability in general anaesthesia. |
|
Scientific Title of Study
|
“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" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhargav Fadadu |
| Designation |
2nd year resident |
| Affiliation |
Govt Medical College Bhavnagar |
| Address |
room no. 301, pg hostel-2,
sir.t.hospital campus,
Bhavnagar,Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9662040034 |
| Fax |
|
| Email |
dr.bfadadu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Shah |
| Designation |
Associate professor |
| Affiliation |
Govt Medical College Bhavnagar |
| Address |
Department Of Anaesthesiology,
Sir.T.Hospital and govt.medical college bhavnagar,
Gujarat
364001
India
Bhavnagar
GUJARAT
364001
India |
| Phone |
09427215252 |
| Fax |
|
| Email |
shah.Komal@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Shah |
| Designation |
Associate professor |
| Affiliation |
Govt Medical College Bhavnagar |
| Address |
Department Of Anaesthesiology,
Sir.T.Hospital and govt.medical college bhavnagar,
Gujarat
364001
India
Bhavnagar
GUJARAT
364001
India |
| Phone |
09427215252 |
| Fax |
|
| Email |
shah.Komal@rediff.com |
|
|
Source of Monetary or Material Support
|
| Govt.medical college and Sir.T.Hospital Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Sir.T.Hospital,Bhavnagar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhargav Fadadu |
Sir.T.Hospital ,Bhavnagar |
Department of anaesthesiology,
goverment medical college and sir.t.hospital ,Bhavnagar
Bhavnagar
GUJARAT |
9662040034
dr.bfadadu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board(Human Ethics Committee) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients undergoing surgery which require general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.3 mg/kg of nalbuphine
|
0.3 mg/kg of nalbuphine diluted up to 10 ml,
intravenously 10 minutes before induction |
| Comparator Agent |
3 µg/kg of fentanyl |
3 µg/kg of fentanyl diluted up to 10ml,
intravenously 10 minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy and safety of nalbuphine and fentanyl in
attenuating
haemodynamic stress response to laryngoscopy and endotracheal
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the sedative effect of nalbuphine and fentanyl
To observe complication if any, in two groups. |
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 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/05/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not get published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |