| CTRI Number |
CTRI/2017/06/008835 [Registered on: 14/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Change in BLOOD PRESSURE and HEART RATE while doing laryngoscopy and intubation |
|
Scientific Title of Study
|
A comparative study of hemodynamic responses to intubation : fentanyl versus
nalbuphine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Col Deepak K Sreevastava |
| Designation |
Professor |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE, PUNE |
| Address |
Dept of Anaesthesiology and Critical Care , AFMC , Pune
SAME AS ADDRESS 1
Pune
MAHARASHTRA
411041
India |
| Phone |
9130456052 |
| Fax |
|
| Email |
dksreevastava@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krunal Bhatt |
| Designation |
Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaethesia
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
7798650722 |
| Fax |
|
| Email |
krunalbhatt1@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
KRUNAL |
| Designation |
RESIDENT |
| Affiliation |
ARMED FORCES MEDICAL COLLEGE, PUNE |
| Address |
DEPARTMENT OF ANAESTHESIA
AFMC
PUNE
DEPARTMENT OF ANAESTHESIA
AFMC
PUNE
Pune
MAHARASHTRA
411041
India |
| Phone |
7798650722 |
| Fax |
|
| Email |
krunalbhatt1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaethesia |
| Address |
Command Hospital
AFMC
Pune |
| 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 |
| Col Deepak K Sreevastava |
COMMAND HOSPITAL |
Room No 1
Department of Anaesthesia
Ch(SC)
Wanworie
PUNE 411041
Pune
MAHARASHTRA |
9130456052
dksreevastava@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research Cell & IEC , AFMC , Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (5) ICD-10 Condition: G00-G99||Diseases of the nervous system, (6) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (7) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (8) ICD-10 Condition: V00-Y99||External causes of morbidity, (9) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (10) ICD-10 Condition: C00-D49||Neoplasms, Patients planned for surgery under general anaesthesia and requiring Laryngoscopy and Orotracheal Intubation in tertiary care hospital, (11) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (12) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FENTANYL |
Fentanyl was first synthesized in 1960 and found to be significantly more potent than commonly used opioids, such as morphine or meperidine. The large safety margin, relatively short duration of action, and minimal respiratory depression at analgesic doses observed for fentanyl soon made it the drug of choice for intravenous anaesthesia. Its ability to provide cardiovascular stability and to block the stress response to surgical stimuli at high doses made it the mainstay of cardiac anaesthesia.
Dose : 2mcg/kg
Frequency : Single dose
Route of administration : intravenous
Total duration of therapy : Single dose , Once
|
| Intervention |
NALBUPHINE |
Fentanyl was first synthesized in 1960 and found to be
significantly more potent than commonly used opioids,
such as morphine or meperidine. The large safety margin,
relatively short duration of action, and minimal respiratory
depression at analgesic doses observed for fentanyl soon
made it the drug of choice for intravenous anaesthesia.
Its ability to provide cardiovascular stability and to block
the stress response to surgical stimuli at high doses made
it the mainstay of cardiac anaesthesia.
Nalbuphine is a semi-synthetic opioid agonist-antagonist
analgesic of the series. It is chemically
related to the widely used opioid antagonists,
and , and the potent opioid analgesic,
. It is agonist at
. Nalbuphine is a potent
analgesic. Its analgesic potency is essentially equivalent
to that of morphine on a milligram basis
Dose 0.2mg/kg
Frequency : Single dose
Route of administration : intravenous
Total duration of therapy : Single dose , Once
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.AMERICAL SOCIETY OF ANESTHESIOLOGY PHYSICAL STATUS GRADE 1 & 2
2.WEIGHT BETWEEN 20-80 KG
3.Patients planned for surgery under general anaesthesia and requiring Laryngoscopy and Orotracheal Intubation in tertiary care hospital |
|
| ExclusionCriteria |
| Details |
1.AMERICAL SOCIETY OF ANESTHESIOLOGY PHYSICAL STATUS GRADE MORE THAN 2
2.History of Hypertension, Diabetes, Cardiac disease, Bronchospastic Diseases
3.Patients on Beta Blockers
4.History of allergy to trial drugs
5.Emergency Surgeries , Difficult intubations
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of I.V Fentanyl and I.V
Nalbuphine during laryngoscopy and
intubation on
Heart rate (HR)
Systolic blood pressure SBP
Diastolic blood pressure DBP
2. To compare side effects and complications of both
drugs. |
2 Years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare side effects and complications of both
drugs. |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2017 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Fentanyl and Nalbuphine are most commonly used in our setup as a premedication.So our aim was to compare the effects of Fentanyl and Nalbuphine on hemodynamic responses to Endotracheal Intubation to help the selection of better drug. |