| CTRI Number |
CTRI/2018/03/012447 [Registered on: 09/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to study the effect of two drugs, propofol and etomidate on blood pressure and heart rate during anesthesia for spinal surgery. |
|
Scientific Title of Study
|
A comparison of haemodynamic effects between induction agents propofol and etomidate in patients undergoing lumbar spinal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparajita Sinha |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER |
| Address |
IPGMER, ANAESTHESIA DEPARTMENT,244 A.J.C. BOSE ROAD,KOLKATA, WEST BENGAL 700020
North Twentyfour Parganas
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saikat Niyogi |
| Designation |
Associate professor |
| Affiliation |
Bangur institute of neurosciences |
| Address |
D L KHAN ROAD,SSKM HOSPITAL,NEUROSURGERY OT, NEURO ANAESTHESIA DEPARTMENT, BHAWANIPUR,KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831732443 |
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAIKAT NIYOGI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Bangur institute of neurosciences |
| Address |
D L KHAN ROAD,SSKM HOSPITAL,NEUROSURGERY OT, NEURO ANAESTHESIA DEPARTMENT, BHAWANIPUR,KOLKATA
North Twentyfour Parganas
WEST BENGAL
700020
India |
| Phone |
9831732443 |
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
|
Source of Monetary or Material Support
|
| BANGUR INSTITUTE OF NEUROSCIENCES,D L KHAN ROAD,SSKM HOSPITAL, NEURO ANAESTHESIA DEPARTMENT, BHAWANIPUR,KOLKATA 700020,WEST BENGAL |
|
|
Primary Sponsor
|
| Name |
Bangur Institute of Neurosciences |
| Address |
Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata, West Bengal 700020 |
| 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 |
| SAIKAT NIYOGI |
Bangur Institute Of Neurosciences |
D L KHAN ROAD,Neurosurgery OT, Department of Anaesthesiology
Kolkata
WEST BENGAL |
9831732443
saikatneuro1972@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER INSTITUTIOAL ETHECAL COMMITE ,IPGMER, KOLKATA Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing elective lumbar spinal surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Etomidate |
intravenous Etomidate infusion 0.05 mg per kg per min ( FROM TIME OF ETOMIDATE ADMINISTATION UPTO LOSS OF EYE LASH REFLEX) |
| Intervention |
Propofol |
intravenous Propofol infusion 0.5 mg per kg per min during induction ( FROM TIME OF PROPOFOL ADMINISTATION UPTO LOSS OF EYE LASH REFLEX) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients posted for elective lumbar spinal surgeries |
|
| ExclusionCriteria |
| Details |
Children
Patients with known significant cardiac, respiratory, hepatic, renal, neurological diseases.
Patient refusal .
Haematological or endocrinal disorder.
Known allergy to study drugs.
Bleeding or coagulation abnormalities.
Psychiatric disease.
History of drug abuse.
Mallampati Grade 3&4
|
|
|
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 |
| Mean Arterial Pressure |
before giving premedication, before induction of anesthesia, immediately after induction of anaesthesia, at intubation and 1, 3, and 5 min after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate, Cardiac output, Bispectral index |
before giving premedication, before induction of anesthesia, immediately after induction of anaesthesia, at intubation and 1, 3, and 5 min after intubation
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/06/2016 |
| Date of Study Completion (India) |
04/06/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It was a parallel group, double blind, randomised controlled study where
the goal was to compare the haemodynamic effects of Propofol and Etomidate as
induction agents in lumbar spine surgeries. 70 patients of ASA Grade I & II of either sex, aged
between 20 to 65 years undergoing elective lumbar spine surgery under
general anesthesia were randomly divided into two groups: Group P received BIS
guided infusion propofol @ 0.5 mg/kg/min and group E received BIS guided
infusion etomidate @0.05mg/kg/min. Heart rate(HR), oxygen saturation (Spo2),
mean arterial pressure(MAP), cardiac output(CO), stroke volume variation(SVV)
were measured at preoperative baseline level, before giving premedication, at
induction, intubation, then at 1 min, 3mins & 5 mins following intubation.
Demographic profiles
and baseline parameters of the patients with regards to HR, MAP, CO, SVV, Spo2
and BIS of the patients of both the groups were comparable.
Till intubation HR, CO
and MAP were decreased in both the groups but the fall was sharper in P group.
1min following intubation, there was transient rise in all these parameters
which came down around baseline in P group but remained at higher level in E
group following 3 & 5 mins after intubation. Rescue drugs were required in
case of E group subjects. SVV was not affected by study drugs.
Based on the results derived from this study, it can be
concluded that when we compared Propofol & Etomidate for BIS guided
induction in lumbar spine surgeries, the hemodynamic surge with etomidate
lasted for a longer period, whereas, in propofol group hemodynamic status was
maintained within normal range. So, we can say, though, etomidate is a superior
induction agent in cardiac surgeries, role of etomidate as induction agent in
spinal surgery is debatable & not cost effective.
|