| CTRI Number |
CTRI/2015/08/006112 [Registered on: 19/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
03/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two drugs fentanyl and dexmedetomidine in decreasing airway and circulatory reflexes during patient coming out of anaesthesia and extubation
|
|
Scientific Title of Study
|
Comparison of fentanyl with dexmedetomidine in attenuating airway and circulatory reflexes during emergence and extubation:
a randomized 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 |
DR RANIP |
| Designation |
Associate professor |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of anaesthesiology
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
Department of anaesthesiology
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
09443116908 |
| Fax |
|
| Email |
anaesrani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RANIP |
| Designation |
Associate professor |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of anaesthesiology
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
Department of anaesthesiology
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
PONDICHERRY
607402
India |
| Phone |
09443116908 |
| Fax |
|
| Email |
anaesrani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RANIP |
| Designation |
Associate professor |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of anaesthesiology
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
Department of anaesthesiology
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
PONDICHERRY
607402
India |
| Phone |
09443116908 |
| Fax |
|
| Email |
anaesrani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College And Research Institute,Pillayarkuppam, Pondicherry 607402 |
|
|
Primary Sponsor
|
| Name |
no |
| Address |
not applicable |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Rani P |
Operation theater, Mahatma Gandhi medical college and research institute, PONDICHERRY |
OPERATION THEATER
DEPARTMENT OF ANAESTHESIOLOGY
MAHATMA GANDHI MEDICAL COLLEGE AND RESERACH INSTITUE
PONDICHERRY
Pondicherry
PONDICHERRY |
9443116908
anaesrani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA PHYSICAL STATUS 1/2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
Dexmedetomedine 0.75mcg per kg given over 10 minutes given 5 minutes before giving neostigmine |
| Comparator Agent |
FENTANYL |
Fentanyl given 1mcg per kg 5 minutes before giving inj. neostigmine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Willingness
• ASA 1 & 2 physical status
|
|
| ExclusionCriteria |
| Details |
1. Active upper respiratory tract infection
2. Who require intraoperative nasogastric tube
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
airway reflexes before extubation
smoothness of extubation |
1.airway reflexes are assessed just before extubation
2.Smoothness is assessed during extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean arterial pressure |
2 mins interval from study drug administration to 15 mins after extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Actaanaesthesiologicascandinavica 1995; 39 (1): 85-89.
BarkhaBindu, SurenderPasupuleti, Upender P.Gowdetal. A double blind, randomized, controlled trial to study the effect of dexmedetomidine on hemodynamic and recovery responses during tracheal extubation. J AnaesthesiolClinPharmacol.2013 Apr-Jun; 29(2): 162–167. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All patients will
receive a standardized anesthetic protocol. Premedication will be done with
oral diazepam 10mg in the night and tab ranitidine 150 mg on the morning of the
surgery. On the OR table after securing IV access inj Midazolam 1mg and
injOndansetron 4 mg are given. Base line hemodynamic parameters will be noted.
Analgesia will be provided with morphine 0.1 mg kg1and additional
morphine based on hemodynamic alterations. Patients will be induced with 5 mg kg1 inj
Thiopentone. Anesthesia will be maintained with Isoflurane and low flow Nitrous
oxide (N2O) & oxygen (600 ml) with total MAC of 1.3. Muscle relaxation
will be achieved with inj. Vecuronium. Fifteen minutes before expected last
surgical suture, isoflurane is cut off and equal amount of test solution which is taken
by draw of lots will be given when TOF
ratio is 30%..Hemodynamic parameters are noted every 2 minutes from the time of
giving study drug to 15 minutes after extubation.The observers are unaware of
the study treatment. 5 min after bolus drug, patient is reversed andgrading ofairway reflexes are done. Airway reflexes are assessed by a 5 point
scoring system.
•
Grade1-excellent(fully
reversed, breathing well, awake, no response to laryngoscopy & suctioning)
•
Grade2 -
good (fully reversed,breathing well ,no coughing on tube, and awake)
•
Grade3 -
satisfactory (fully reversed, no coughing on tube, breathing well and drowsy)
•
Grade 4 -
poor (fully reversed, coughing on tube ,breathing well and drowsy )
•
Grade 5 -
very poor (coughing on tube with irregular attempts to breath and not awake)
Changes in heart
rate (HR) and blood pressure (BP) will be measured during and after tracheal
extubation every minute for five minutes. Oro-pharyngeal secretions will be
aspirated gently before extubation. Occurrence of cough, laryngospasm, and
bronchospasm will be noted.
All patients will
receive a standardized anesthetic protocol. Premedication will be done with
oral diazepam 10mg in the night and tab ranitidine 150 mg on the morning of
the surgery. On the OR table after securing IV access inj Midazolam 1mg and
injOndansetron 4 mg are given. Base line hemodynamic parameters will be
noted. Analgesia will be provided with morphine 0.1 mg kg1and
additional morphine based on hemodynamic alterations. Patients will be induced with 5 mg kg1 inj
Thiopentone. Anesthesia will be maintained with Isoflurane and low flow
Nitrous oxide (N2O) & oxygen (600 ml) with total MAC of 1.3.
Muscle relaxation will be achieved with inj. Vecuronium. Fifteen minutes
before expected last surgical suture, isoflurane is cut off and equal amount of test solution which is taken
by draw of lots will be given when TOF
ratio is 30%..Hemodynamic parameters are noted every 2 minutes from the time
of giving study drug to 15 minutes after extubation.The observers are unaware
of the study treatment. 5 min after bolus drug, patient is reversed andgrading ofairway reflexes are done. Airway reflexes are assessed by a 5 point
scoring system.
• Grade1-excellent(fully reversed,
breathing well, awake, no response to laryngoscopy & suctioning)
• Grade2 - good (fully reversed,breathing
well ,no coughing on tube, and awake)
• Grade3 - satisfactory (fully reversed,
no coughing on tube, breathing well and drowsy)
• Grade 4 - poor (fully reversed, coughing
on tube ,breathing well and drowsy )
• Grade 5 - very poor (coughing on tube
with irregular attempts to breath and
not awake)
Changes
in heart rate (HR) and blood pressure (BP) will be measured during and after
tracheal extubation every minute for five minutes. Oro-pharyngeal secretions
will be aspirated gently before extubation. Occurrence of cough,
laryngospasm, and bronchospasm will be noted.
O2&N2O
O2
15min
5 min laterTOF
Isoflurane off bolus study drug reversal assessment
During
extubation smoothness is graded as,
Grade 1- no coughing on endotracheal tube
Grade 2- coughing on the
ETT
Grade 3-
vomiting
Grade 4-
laryngospasm |