| CTRI Number |
CTRI/2018/02/011696 [Registered on: 05/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs for awake airway intubation in anaesthesia |
|
Scientific Title of Study
|
Comparison of fentanyl and nalbuphine on intubating conditions and haemodynamic responses during awake fiberoptic intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachin Chaudhary |
| Designation |
Post Graduate Student |
| Affiliation |
University College of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical Care Second Floor Ward and OT Block UCMS and GTB Hospital East DELHI 110095 India
East
DELHI
110095
India |
| Phone |
8826140889 |
| Fax |
|
| Email |
sachin.ucms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujata Chaudhary |
| Designation |
Director Professor |
| Affiliation |
University College Of Medical Sciences |
| Address |
Department of Anaesthesia and Critical and Critical Care Second Floor Wards and OT Block UCMS and GTB Hospital East DELHI 110095 India
East
DELHI
11095
India |
| Phone |
9868399705 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujata Chaudhary |
| Designation |
Director Professor |
| Affiliation |
University College Of Medical Sciences |
| Address |
Department of Anaesthesia and Critical and Critical Care Second Floor Wards and OT Block UCMS and GTB Hospital East DELHI 110095 India
East
DELHI
11095
India |
| Phone |
9868399705 |
| Fax |
|
| Email |
sujatac462@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur, Hospital ,New Delhi Dilshad Garden 110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences |
| Address |
Dilshad Garden ,New Delhi |
| 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 |
| Sachin Chaudhary |
University College of Medical Sciences and Guru Teg Bahadur Hospital |
Department of Anaesthesiology and Critical Care Second Floor Wards and OT Block East DELHI
East
DELHI |
8826140889
sachin.ucms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee -Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients posted for Surgery under General Anaesthesia , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Fentanyl with intravenous Nalbuphine |
2microgm/kg Intravenous Fentanyl with 0.2mg/kg Intrvenous Nalbuphine |
| Intervention |
Intravenous Nalbuphine with intravenous Fentanyl |
0.2mg/kg Intravenous Nalbuphine with 2microgm/kg Intravenous Fentanyl |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American society of Anaesthesiology grade I and grade II
Patients belonging to MPG-I and MPG-II and Weight 40to 80 kg |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with known allergy to trial drugs
ASA-III and ASA-IV patients
MPG-III and MPG-IV patients
Emergency and obstetric surgeries
Patients with respiratory disease
Patient on beta blockers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cough score
Tolerance to intubation was evaluated by post intubation score
Level of sedation was evaluated by Ramsay sedation score |
0,5,10,15,20 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate
Systolic Blood Pressure and Diastolic Blood Pressure
Mean Arterial Pressure
Spo2 |
2,5,10,15 minute after intubation |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/12/2015 |
| Date of Study Completion (India) |
04/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study title : Comparison of fentanyl and nalbuphine on intubating conditions and haemodynamic responses during awake fiberoptic intubation
Rationale: Fiberoptic intubation is useful technique to secure airway in patients who have a difficult airway in terms of mouth opening and where conventional laryngoscopy is not possible .Opioids like fentanyl are commonly used to assist in the procedure .Recently,nalbuphine has used in conventional laryngoscopy and was found to be promising with minimal side effects . |