| CTRI Number |
CTRI/2024/10/075284 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Impact of Two Doses of Dexmedetomidine on Extubation Quality in Adult Patients. |
|
Scientific Title of Study
|
Effect of two different doses of Dexmedetomidine on extubation quality score during tracheal extubation in adult patients,a Comparative 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 |
Snehal Patel |
| Designation |
Resident doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9313036963 |
| Fax |
|
| Email |
drsnehalpatelgmcs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejash Sharma |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9427332100 |
| Fax |
|
| Email |
drtejashs.sbks@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejash Sharma |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex ,2nd Floor, Dhiraj
Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre , Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9427332100 |
| Fax |
|
| Email |
drtejashs.sbks@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen |
| Address |
Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
| Type of Sponsor |
Private 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 |
| Dr Tejash H Sharma |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
2nd Floor,General ot complex,Anesthesia Department,Dhiraj hospital,Smt. Bhikiben Kanjibhai Shah Medical Institute and
Research Centre ,Sumandeep vidyapeeth Wagodhia , Pipariya, Vadodara Wagodhia ,
Pipariya, Vadodara
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT |
9427332100
drtejash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous infusion of Dexmedetomidine 0.3 mcg/kg |
Intravenous infusion of Dexmedetomidine 0.3 mcg/kg over 10 minutes, just 10 minutes prior to skin closure |
| Intervention |
Intravenous infusion of Dexmedetomidine 0.5 mcg/kg |
Intravenous infusion of Dexmedetomidine 0.5 mcg/kg over 10 minutes, just 10 minutes prior to skin closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign informed consent
Male or Female patients between 18 to 65 years of age
Patients belonging to American Society of Anesthesiologists(ASA) physical status I & II
Patients posted for elective surgeries under general anesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in study.
Patients with Body Mass Index more than 29 Kg per m square
Patient with arrhythmias
Pregnancy and lactating women
Patients belonging to American Society of Anesthesiologists (ASA) III and above.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study haemodynamics and respiratory response during extubation. |
Preoperative
After test drug administration
After reversal
During extubation
After extubation
At 1 min
At 2 min
At 3 min
At 4 min
At 5 min
At 15 min
At 30 min
At 45 min
At 60 min
At 75 min
At 90 min
At 105 min
At 120 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study sedation score after extubation or any side effects. |
Ramsay sedation score (RSS) will be recorded every 5minutes for 30 minutes and then every 30 minutes till 120 minutes. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/12/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - drtejash@gmail.com
- For how long will this data be available start date provided 20-11-2025 and end date provided 20-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Effect of two different doses of dexmedetomidine on extubation quality score during tracheal extubation in adult patients-A comparative study To study the effect of two different doses of dexmedetomidine on extubation quality score during tracheal extubation in adult patients. Objective is to study the hemodynamic and respiratory response during extubation, sedation score after extubation and observe the adverse effect or side effect. Inclusion criteria: Patients willing to sign informed consent, male or female patients between 18 to 65 years of age, patients belonging to American Society of Anesthesiologists (ASA) physical status I & II and patients posted for elective surgeries under general anesthesia. Exclusion criteria:· Patients unwilling to participate in study, patients with Body Mass Index more than 29 Kg per m square, patient with arrhythmia, pregnancy and lactating women, patients belonging to American Society of Anesthesiologists (ASA) III and above. We will be conducting this on 72 adults aged 18-60 yrs belonging to grade I & II of American Society of Anesthesiologists (ASA) classification who will undergo elective surgeries under general anesthesia. They will be divided into 2 equal groups with chit method. Group D1 (0.3µg/kg) and Group D2 (0.5μg/kg) of 36 patients each based on clinical conditions and the study drug will be administered by the consultant anesthesiologist present in the operation theatre there prior to extubation. Post extubation haemodynamic parameters will be recorded at baseline before test drug, after test drug, during extubation and every 1 minute for first 5 minutes, then every 15 minutes up to 2 hours after extubation. The primary outcome included quality of extubation will be assessed by 5-point scale and will be recorded every 5minutes for 30 minutes and then every 30 minutes till 120 minutes.. Ramsay sedation score (RSS) will be recorded every 5minutes for 30 minutes and then every 30 minutes till 120 minutes. Site of Study: Department of Anesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara Study Design: Prospective, double blinded and comparative study. Study Duration: The study will be initiated after obtaining permission from institutional ethics committee till the achievement of the sample size or by 18 months whichever is earlier. Statistics: Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student-t test and/or ANNOVA will be used wherever appropriate for between-groups comparisons, while for categorical variables; chi-square test will be used. P value <0.05 will be considered statistically significant. Likely outome/benifit: This prospective and comparative study will help us to compare the efficacy between two different doses of dexmedetomidine in attenuating hemodynamic responses to endotracheal extubation in patients undergoing surgeries under general anesthesia by having better outcome in hemodynamics. |