| CTRI Number |
CTRI/2024/12/077710 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to compare mental and motor recovery after intravenouos dexmedetomidine or intravenous low dose ketamine in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison of psychomotor recovery of intravenous dexmedetomidine bolus with
intravenous subanaesthetic ketamine in patients undergoing general anaesthesia: A
prospective randomized double blind study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kancharla Manikumar |
| Designation |
Junior Resident |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical care, Sri venkateswara institute of medical sciences, Tirupati.
Chittoor
ANDHRA PRADESH
517501
India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
|
| Fax |
|
| Email |
drkmanikumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Hemanth |
| Designation |
Professor |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical care, SVIMS, Tirupati.
Chittoor
ANDHRA PRADESH
517501
India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9440285634 |
| Fax |
|
| Email |
hemanthn1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Hemanth |
| Designation |
Professor |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical care, SVIMS, Tirupati.
Chittoor
ANDHRA PRADESH
517501
India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9440285634 |
| Fax |
|
| Email |
hemanthn1973@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences,Alipiri road,Tirupati-517501,Andhra
Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Alipiri road, Tirupati- 517501, Andhra Pradesh,India |
| Type of Sponsor |
Other [NIL] |
|
|
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 Kancharla Manikumar |
Sri Venkateswara Institute of Medical Sciences |
Department of
Anaesthesiology and
CC, SVIMS, Alipiri road,
TIRUPATI, 517501.
Chittoor
ANDHRA PRADESH
Chittoor
ANDHRA PRADESH |
8374612192
drkmanikumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical Sciences, Tirumala Tirupati Devastanams,T irupati.INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients aged 18-65 undergoing elective surgeries under general anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous dexmedetomdine |
preoperatively before induction of anaesthesia intravenous dexmedetomidine 1mcg/kg intravenously given over 15 minutes |
| Comparator Agent |
intravenous subanaesthetic ketamine |
preoperatively before induction of anaesthesia subanaesthetic dose of ketamine at 0.25mg /kg given intravenouly over 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.age between 18-65 years
2.ASAPS I, II III
30. Patients scheduled for surgeries under general anaesthesia.
3. Minimum duration of surgery lasting more than 180 minutes. |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate in the study.
2. Patients who are unable to give informed consent.
3. Patients with known history of psychiatric illness, chronic drug or alcohol abuse.
4. Patients with known hypersensitivity to drugs used.
5. Pregnant and lactating women.
6. BMI>30kg/m 2 .
7. Patients on concurrent sedative medications.
8. Patients who are unable to attempt or perform the DSST test. |
|
|
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 |
to compare the psychomotor recovery profile of patients
receiving either IV dexmedetomidine bolus (Group D) or subanaesthetic ketamine bolus
(Group K) by Digit Symbol Substitution Test (DSST) postoperatively at 15,30,60,90,120 minutes post extubation |
to compare the psychomotor recovery profile of patients
receiving either IV dexmedetomidine bolus (Group D) or subanaesthetic ketamine bolus
(Group K) by Digit Symbol Substitution Test (DSST) postoperatively at 15,30,60,90,120 minutes post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| additional boluses of fentanyl given |
intraoperatively |
| propofol boluses given |
intraoperatively |
| to Compare Postoperative sedation |
15,30,60,90,120 minutes postoperatively |
| time to first request of analgesia |
postoperatively |
| hemodynamic changes |
post induction immediately |
|
|
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)
|
15/12/2024 |
| 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 |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dexmedetomidine an α 2 agonist has replaced propofol as primary maintenance anaesthetic. Ketamine, an N-methyl aspartate antagonist(NMDA antagonist), at subanaesthetic doses,
poses centrally mediated analgesic property with minimum effect on
consciousness and cognition. it is aimed to replace the bolus dose of dexmedetomidine with subanaesthetic dose of
ketamine for better hemodynamic stability.
Psychomotor tests address the intermediate recovery of the patient and also it denotes
the restoration of the patient to street fitness. Digit symbol substitution test, a form of pen and pencil test used for assessing cognition,
memory attention ,and it also correlates with real world functional outcomes like the ability
to accomplish everyday tasks.
|