| CTRI Number |
CTRI/2024/06/069611 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ease of Laryngeal Mask Airway insertion after patient has been given any of the following drug combinations namely Propofol-Ketamine vs Propofol-Fentanyl vs Propofol-Dexmedetomidine.( Laryngeal mask airway is a device used to quickly secure the airway). |
|
Scientific Title of Study
|
Comparison of Laryngeal Mask Airway insertion score following Propofol-Ketamine vs Propofol-Fentanyl vs Propofol-Dexmedetomidine Anaesthesia in patients undergoing short surgical procedures. |
| 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 Varsha Sinha |
| Designation |
PG resident |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Room no. 418, 4th floor, Department of Anesthesiology, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, PENDRI , RAJNANDGAON
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8269289745 |
| Fax |
|
| Email |
varsha.sinha03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smriti Bandhu |
| Designation |
Associate Professor |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Room no. 418, 4th floor, Department of Anesthesiology, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, PENDRI , RAJNANDGAON
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
7000562486 |
| Fax |
|
| Email |
drsmriti19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smriti Bandhu |
| Designation |
Associate Professor |
| Affiliation |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Room no. 418, 4th floor, Department of Anesthesiology, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, PENDRI , RAJNANDGAON
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
7000562486 |
| Fax |
|
| Email |
drsmriti19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon, Chhattisgarh 491441 |
|
|
Primary Sponsor
|
| Name |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
| Address |
Department of Anaesthesiology, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon, Chhattisgarh 491441 |
| 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 |
| Dr Varsha Sinha |
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon |
Room no. 418, 4th floor, Department of Anaesthesiology, Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Pendri, Rajnandgaon
Rajnandgaon
CHHATTISGARH |
8269289745
varsha.sinha03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, BRLSABVM MEDICAL COLLEGE, RAJNANDGAON |
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 |
Propofol-Ketamine, Propofol-Fentanyl, Propofol-Dexmedetomidine |
We are going to compare the ease of laryngeal mask airway insertion in terms of mouth opening/ jaw relaxation, patient’s response such as swallowing, coughing/ gagging, patient movements and laryngospasm after administration of following drugs-
1. Injection Propofol (1.5 to 2.5 mg/ kg) intravenously + injection Ketamine ( 1mg/kg) iv
2. Injection Propofol (1.5 to 2.5 mg/ kg) intravenously + injection Fentanyl ( 1mcg /kg) iv
3. Injection Propofol (1.5 to 2.5 mg/ kg) intravenously + injection Dexmedetomidine (1mcg/kg) iv
|
| Intervention |
Laryngeal mask airway insertion |
We are going to compare the ease of laryngeal mask airway insertion in terms of mouth opening/ jaw relaxation, patient’s response such as swallowing, coughing/ gagging, patient movements and laryngospasm.
(Duration- Till the end of surgical procedure which is usually less than 45 min as we are doing this study in patients undergoing short surgical procedures) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 60 years
ASA I-II
Patients undergoing elective short surgical procedures |
|
| ExclusionCriteria |
| Details |
Patients refusal
Hemodynamically unstable patients
Mallampatti grade 3/4
History of OSA |
|
|
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 |
| LMA insertion score (In terms of mouth opening/jaw relaxation , ease of insertion and patient’s response such as swallowing, coughing/gagging, patient movement and laryngospasm). |
LMA insertion score (In terms of mouth opening/jaw relaxation , ease of insertion and patient’s response such as swallowing, coughing/gagging, patient movement and laryngospasm) will be assessed at the time of LMA insertion( 30 seconds to 1 min after Propofol administration) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Systolic BP, Diastolic BP, Mean arterial BP, HR, RR , arterial oxygen saturation , ECG, End- tidal CO2 |
BP, HR, RR, SpO2, ETCO2, ECG noted at 1min, 3min, 5min, 7min, 10min and then every 5 min till the end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
10/07/2024 |
| 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="0"
Months="3"
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
|
Study Title : Comparison of Laryngeal mask airway insertion score following Propofol-Ketamine vs Propofol-Fentanyl vs Propofol- Dexmedetomidine anaesthesia in patients undergoing short surgical procedures. Rationale: Insertion of laryngeal mask airway (LMA) requires sufficient depth of anesthesia for jaw muscles to relax and suppression of airway reflexes for the device to be tolerated within the hypopharynx without undue coughing, gagging, and patient movement. Such conditions are provided by a generous dose of an intravenous (IV) anesthetic induction agent. Propofol itself does not have analgesic activity and when used alone, the high doses required for induction may cause adverse cardiovascular effects. In this study we are comparing three drug combinations namely Propofol-Ketamine, Propofol-Fentanyl , Propofol-Dexmedetomidine that which drug combination provides better LMA insertion conditions. Aim: To compare the Laryngeal Mask Airway insertion score following Propofol-Ketamine vs Propofol-Fentanyl vs Propofol-Dexmedetomidine anaesthesia in patients undergoing Short Surgical Procedures. Objectives: To compare the Laryngeal Mask Airway insertion conditions in terms of- - mouth opening/jaw relaxation ,
- ease of insertion
- patient’s response such as swallowing, coughing/gagging,
- patient movement and
- laryngospasm
To compare the Hemodynamic changes following anaesthesia in all the three groups
Study Design : Prospective, randomized, interventional study
Study Setting : Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College and Hospital, Rajnandgaon, Chhattisgarh
Time Frame : July 2024 to September 2024
Study Approval : Institutional Scientific & Ethics Committee
Study Population : Patients scheduled for elective surgeries at B.R.L.S.A.B.V.M. Medical College, Rajnandgaon
|