| CTRI Number |
CTRI/2023/01/048751 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Between Dexmedetomidine-Propofol Injection And Thiopentone-Propofol Injection During I-gel Insertion In General Anaesthesia |
|
Scientific Title of Study
|
Comparative Study Of Dexmedetomidine-Propofol Injection Versus Thiopentone-Propofol Injection On I-Gel Insertion Conditions In Patients Undergoing General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SANDESH RATHOD |
| Designation |
Post Graduate Trainee (MD Anaesthesiology) |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY,BANKURA SAMMILANI MEDICAL COLLEGE,BANKURA |
| Address |
Department of Anaesthesiology,
room No.3,
Ground floor,Surgery Building,Bankura Sammilani Medical College,Bankura
Room No.62,4th floor
Rabin Hall,
Kenduadihi,
Bankura.
pin: 722102
Bankura
WEST BENGAL
722102
India |
| Phone |
9892921143 |
| Fax |
|
| Email |
srkumarsandesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHAITALI BISWAS |
| Designation |
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY,BANKURA SAMMILANI MEDICAL COLLEGE,BANKURA |
| Address |
Department of Anaesthesiology,
room No.3,
Ground floor,Surgery Building,Bankura Sammilani Medical College,Bankura
Bankura
WEST BENGAL
722102
India |
| Phone |
9051062616 |
| Fax |
|
| Email |
drchaitali.b9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANDESH RATHOD |
| Designation |
Post Graduate Trainee (MD Anaesthesiology) |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY,BANKURA SAMMILANI MEDICAL COLLEGE,BANKURA |
| Address |
Department of Anaesthesiology,
room No.3,
Ground floor,Surgery Building,Bankura Sammilani Medical College,Bankura
Bankura
WEST BENGAL
722102
India |
| Phone |
9892921143 |
| Fax |
|
| Email |
srkumarsandesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY,BANKURA SAMMILANI MEDICAL COLLEGE,BANKURA |
|
|
Primary Sponsor
|
| Name |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
BANKURA SAMMILANI MEDICAL COLLEGE,KENDUADIHI,BANKURA,WEST BENGAL,PIN:722102 |
| Type of Sponsor |
Government medical college |
|
|
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 SANDESH RATHOD |
BANKURA SAMMILANI MEDICAL COLLEGE AND HOSPITAL |
GENERAL SURGERY,GYNAE-OBSTETRICS AND ORTHOPAEDICS OPERATION THEATRE,UNDER DEPARTMENT OF ANESTHESIOLOGY,BANKURA SAMMILANI MEDICAL COLLEGE,BANKURA.
Bankura
WEST BENGAL |
9892921143
srkumarsandesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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: N201||Calculus of ureter, (2) ICD-10 Condition: M624||Contracture of muscle, (3) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (4) ICD-10 Condition: N812||Incomplete uterovaginal prolapse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I-GEL INSERTION CONDITIONS USING DEXMEDETOMIDINE-PROPOFOL INJECTION (GROUP DP) |
WHEN AN APPROPRIATE DEPTH OF ANAESTHESIA WAS ACHIEVED THE HEAD WAS PLACED IN THE DORSIFLEXION SNIFFING POSITION AND PROPER SIZED I-GEL INSERTED. (SELECTION OF I-GEL WAS DONE ON THE WEIGHT OF PATIENTS,USUALLY SIZE 3 FOR WOMEN AND SIZE 4 FOR MEN) AND THE I-GEL INSERTION IN DP GROUP WAS DONE USING DEXMEDETOMIDINE(1MCG/KG) DILUTED WITH 10 ML 0.9% NS OVER 10 MINUTES BY INFUSION PUMP (INFUSOR 950,EMCO,INDIA) FOLLOWED 5ML NS OVER 2 MINUTES FOLLOWED PROPOFOL 1% (0.25ML/KG). HEART RATE,MEAN BLOOD PRESSURE,MEAN APNEA TIME,COUGHING,GAGGING,LIMB AND HEAD MOVEMENTS WAS COMPARED.
THE DURATION OF TOTAL TRIAL WILL BE 12 MONTHS. |
| Comparator Agent |
I-GEL INSERTION CONDITIONS USING THIOPENTONE-PROPOFOL INJECTION (GROUP TP) |
WHEN AN APPROPRIATE DEPTH OF ANAESTHESIA WAS ACHIEVED THE HEAD WAS PLACED IN THE DORSIFLEXION SNIFFING POSITION AND PROPER SIZED I-GEL INSERTED. (SELECTION OF I-GEL WAS DONE ON THE WEIGHT OF PATIENTS,USUALLY SIZE 3 FOR WOMEN AND SIZE 4 FOR MEN) AND THE I-GEL INSERTION IN TP GROUP WAS DONE USING 10 ML OF 0.9% NS OVER 10 MINUTES BY INFUSION PUMP (INFUSOR 950,EMCO,INDIA) FOLLOWED BY INJECTION OF ADMIXTURE OF THIOPENTONE AND PROPOFOL IN 1:1 RATIO (1.25% AND 0.5% RESPECTIVELY) IN A DOSE OF 0.25 ML/KG. HEART RATE,MEAN BLOOD PRESSURE,MEAN APNEA TIME,COUGHING,GAGGING,LIMB AND HEAD MOVEMENTS WAS COMPARED.
THE DURATION OF TOTAL TRIAL WILL BE 12 MONTHS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
.PATIENTS BELONGING TO ASA GRADE 1 AND ASA GRADE2
.PATIENTS UNDERGOING ELECTIVE SURGERIES. |
|
| ExclusionCriteria |
| Details |
.UNWILLING PATIENT
.PATIENTS HAVING BMI >30 KG/M2
.ORAL OR NASAL SURGERY
.ANTICIPATED OR KNOWN DIFFICULT INTUBATION OR VENTILATION
.PATIENTS WITH LIMITED MOUTH OPENING (<2CM)
.H/O ALLERGY TO ANY STUDY DRUGS
.PATIENTS WITH DIFFICULT COMMUNICATIONS
.PATIENTS AT INCREASED RISK OF ASPIRATION OR HAVING A HISTORY OF SYMPTOMATIC GASTROESOPHAGEAL REFLUX OR HIATAL HERNIA |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO FIND THE DIFFERENCE IN CHANGES IN HEART RATE,MEAN BLOOD PRESSURE,MEAN APNEA TIME IN BOTH GROUPS |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO FIND AND COMPARE THE INCIDENCE OF JAW RELAXATION, INTRA-OP LARYNGOSPASM,COUGHING,GAGGING,LIMB AND HEAD MOVEMENT AND OVERALL I-GEL INSERTION CONDITION IN BOTH GROUPS. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
09/01/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
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-identiļ¬cation.
- 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 who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [srkumarsandesh@gmail.com].
- For how long will this data be available start date provided 09-08-2023 and end date provided 09-08-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
MAINTAINANCE OF THE AIRWAY IS AN INTEGRAL PART OF GENERAL ANAESTHESIA. THERE ARE WIDE VARIETY OF SUPRAGLOTTIC AIRWAY DEVICES USED TO MAINTAIN VENTILATION.AMONG THE SECOND GENERATION SUPRAGLOTTIC DEVICES, I-GEL INSERTION IS EASIER AND CAUSES LESSER MORBIDITY OVER OTHER SUPRAGLOTTIC AIRWAY DEVICES.IN THE PRESENT STUDY INSERTION CONDITION OF I-GEL USING DEXMEDETOMIDINE-PROPOFOL (DEXMED:1MCG/KG OVER 10 MINUTES AND PROPOFOL:1 % 0.25ML/KG) INJECTION AND THIOPENTONE-PROPOFOL (ADMIXTURE OF 1.25% OF THIOPENTONE AND 0.5% OF PROPOFOL @0.25ML/KG) IN RANDOMISED DOUBLE BLIND GROUPS WILL BE DONE.EXPECTED OUTCOME IN THIS STUDY WOULD BE COMPARABLE CHANGES IN HEART RATE,MEAN BLOOD PRESSURE,MEAN APNEA TIME WILL BE COMPARED IN BOTH GROUPS.OVERALL I-GEL INSERTION CONDITIONS LIKE (COUGHING,GAGGING,LARYNGOSPASM,LIMB AND HEAD MOVEMENTS) WILL ALSO BE COMPARED IN BOTH GROUPS.DATA WILL BE COLLECTED WITH ALL NECESSARY PREPARATION AND PRECAUTIONS USING PRE-DESIGNED PROFORMA AND WILL BE ANALYSED APPROPRIATE STATISTICAL METHODS. |