| CTRI Number |
CTRI/2021/06/034393 [Registered on: 25/06/2021] Trial Registered Prospectively |
| Last Modified On: |
20/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Comparison of recovery of mental and motor skills in patients receving either intravenous propofol or dexmedetomidine infusions as part of balanced general anaesthesia:A prospective randomized single-blind study" |
|
Scientific Title of Study
|
"Comparison of psychomotor recovery in patients receiving either intravenous propofol or dexmedetomidine infusions as part of balanced general anaesthesia: A prospective randomized single-blind study" |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hajira Muzaffar |
| Designation |
MBBS,Postgraduate(MD Anaesthesiology) |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of anaesthesiology, SVIMS, Alipiri road, Tirupati, Andhra pradesh
Alipiri road, Tirupati, Andhra pradesh
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9566200402 |
| Fax |
|
| Email |
hajimuzi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNHemanth |
| Designation |
Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of anaesthesiology, SVIMS,Alipiri road, Tirupati, Andhra Pradesh
Alipiri road, Tirupati, Andhra Pradesh
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9440285634 |
| Fax |
|
| Email |
hemanthn1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNHemanth |
| Designation |
Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of anaesthesiology, SVIMS,Alipiri road, Tirupati, Andhra Pradesh
Alipiri road, Tirupati, Andhra Pradesh
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9440285634 |
| Fax |
|
| Email |
hemanthn1973@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr hajira |
Sri Venkateswara institute of Medical sciences |
department of anaesthesiology, svims, tirupati.
Chittoor
ANDHRA PRADESH |
9566200402
hajimuzi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee of SVIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of psychomotor recovery in patients receiving either intravenous propofol or dexmedetomidine infusions as part of balanced general anaesthesia |
Group Dexmedetomidine(Group D)
1.All participants will receive an IV loading dose of 0.5 mL/kg (1 µg/kg bolus)over 10 min and
2.A maintenance IV infusion of 0.25 mL/kg/hr(0.5µg/kg/hr) will be kept.
Group Propofol(Group P) This group of patients will receive iv loading dose of normal saline of 0.5ml/kg over 10 mins followed by an infusion dosage of 75µg/kg/min of propofol for maintenance .
|
| Comparator Agent |
Comparison of psychomotor recovery in patients receiving either intravenous propofol or dexmedetomidine infusions as part of balanced general anaesthesia |
Group Dexmedetomidine(Group D) 1.All participants will receive an IV loading dose of 0.5 mL/kg (1 µg/kg bolus)over 10 min and 2.A maintenance IV infusion of 0.25 mL/kg/hr(0.5µg/kg/hr) will be kept.
Group Propofol(Group P)
This group of patients will receive iv loading dose of normal saline of 0.5ml/kg over 10 mins followed by an infusion dosage of 75µg/kg/min of propofol for maintenance .
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with American Society of Anaesthesiologists physical status I, II, III aged 18 to 65 years.
2.Patients who are scheduled for surgeries under general anaesthesia.
3.Minimum duration of surgery lasting more than 120 minutes.
|
|
| ExclusionCriteria |
| Details |
1.Patients unwilling to participate in the study.
2.Patients who are unable to give informed consent.
3.BMI>30kg/m2.
4.Patients with known history of psychiatric illness, chronic drug or alcohol abuse.
5.Patients with known hypersensitivity to drugs used.
6.Pregnant and lactating women.
Patients on concurrent sedative medications.
7.Patients who are unable to attempt or perform the DSST test.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the psychomotor recovery of patients receiving iv dexmedetomidine versus iv propofol infusion with Digit Symbol Substitution Test(DSST)[Annexure1] postoperatively |
15 min, 30 min , 60 min , 90 min , 120 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i.To note the number of additional bolus doses of fentanyl and propofol given intraoperatively.
ii.To note the total amount of propofol and fentanyl consumed intraoperatively.
iii.To compare the time taken from stoppage of infusion to opening of eyes before administration of reversal agent.
iv. To assess the sedation of patients with Ramsay Sedation Assessment Scale.
|
15 min, 30 min, 60 min , 90 min, 120 min |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Immediate post-operative
recovery forms a prerequisite for any successful anaesthetic procedure-
especially so in day care surgeries.
The DSST, primarily measures visual recording and
includes a motor component. It is an useful indicator of changes in sensory
processing performance induced by psychoactive tests.There are only a few studies comparing
psychomotor effects of dexmedetomidine and propofol. We hypothesise that a good
DSST score indicates a better recovery from anaesthesia which can translate to
an early discharge from a limited bed available Post Anaesthesia Care Unit
(PACU) to postoperative ward. Therefore, we would like to compare the above
drugs using DSST as a measure of psychomotor recovery surgeries under general
anaesthesia |