| CTRI Number |
CTRI/2024/07/071136 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
LMA protector vs LMA blockbuster in laparoscopic surgeries.
|
|
Scientific Title of Study
|
LMA protector vs LMA Blockbuster in Laparoscopic surgeries
A prospective randomized 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 |
Dr Het Bhatt |
| Designation |
Resident doctor in department of Anesthesiology |
| Affiliation |
Government medical college and hospital, Baroda |
| Address |
2nd floor,
OT Block, Department of Anesthesia Government medical college and hospital (SSGH),
Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9998223682 |
| Fax |
|
| Email |
bhatthv11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha Patwa |
| Designation |
Associate Professor in department of Anesthesiology |
| Affiliation |
Government medical college and hospital, Baroda |
| Address |
2nd floor,
OT BLOCK, Department of Anesthesia,
Government medical college and hospital(SSGH),
Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9879540828 |
| Fax |
|
| Email |
patwaapeksha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha Patwa |
| Designation |
Associate Professor in department of Anesthesiology |
| Affiliation |
Government medical college and hospital, Baroda |
| Address |
2nd Floor,
OT Block, Department of Anesthesia,
Government medical college and hospital(SSGH),
Baroda
Vadodara
GUJARAT
390001
India |
| Phone |
9879540828 |
| Fax |
|
| Email |
patwaapeksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital, Vadodara, Gujarat, India-390001 |
|
|
Primary Sponsor
|
| Name |
Medical college baroda |
| Address |
Government medical college and hospital,
Anandpura,
Baroda, Gujarat,India-390001 |
| 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 Het Bhatt |
Government medical college and hospital, baroda |
2nd Floor, OT Block, Department of Anesthesia Government medical college and hospital, Baroda,Gujarat,India 390001
Vadodara
GUJARAT |
9998223682
bhatthv11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Biomedical and Health research(IECBHR) |
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 |
LMA Blockbuster in Laparoscopic surgery |
After achieving adequate relaxation, by scoline and inhalation agent, keeping the head in sniffing position the SAD is grasped firmly along with the integral bite block with cuff facing the patients chin. Chin needs to be gently pressed down before inserting SAD into patients mouth. Then it is slid towards hard palate with a gentle push until it reaches the soft palate or oropharynx. Then modified jaw thrust technique is applied by lifting the angle of mandible with little fingers and other fingers to stabilise the jaw, and then gently pushing the SAD with thumbs till a resistance is felt or by checking for the integral bite block at incisor teeth. The cuff will be inflated and circuit will be attached. It is kept insitu till Ot gets over. (Less than 4 hours) |
| Intervention |
LMA Protector in Laparoscopic surgery. |
After achieving adequate relaxation, keeping the head in sniffing position the SAD is grasped firmly along with the integral bite block with cuff facing the patients chin. Chin needs to be gently pressed down before inserting SAD into patients mouth. Then it is slid towards hard palate with a gentle push until it reaches the soft palate or oropharynx. Then modified jaw thrust technique is applied by lifting the angle of mandible with little fingers and other fingers to stabilise the jaw, and then gently pushing the SAD with thumbs till a resistance is felt or by checking for the integral bite block at incisor teeth. The cuff will be inflated and circuit will be attached. It is kept insitu till Ot gets over. (Less Than 4hours) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients in age group 18 to 60 years.
2 Either gender.
3 Weight 30 to 70 kg.
4 ASA physical status 1 and 2.
5 Mallampati class 1 and 2.
6 Surgeries requiring less than 4 hours.
7 Patients admitted in SSGH and posted for
Laparoscopic Elective surgeries requiring
general anesthesia.
|
|
| ExclusionCriteria |
| Details |
1 Patient with predicted difficult airway
(mouth opening of less than 2.5cm, cervical spine
problems).
2 Patients with recent upper respiratory tract
infection.
3 Patients with any oropharyngeal pathology.
4 Patient with any known pulmonary disease
(like Asthma, COPD)
5 Obese patients with BMI more than 30 kg/m2.
6 Patient with any conditions that increase the
risk of gastro esophageal regurgitation.
History of allergy to silicon, polyvinyl chloride
or to any drugs used in protocol.
7 Patients not willing for participation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal seal pressure |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for insertion |
At Baseline |
| Number of insertion attempts of SAD & gastric tube |
At Baseline |
| Ease of insertion |
At Baseline |
| fibreoptic view |
At Baseline |
Effect on Hemodynamic Parameters
|
At Baseline and post operative |
Complications like Oro pharyngeal Trauma, Sore throat,
staining of device and Dysphonia. |
in post operative period after 6 hours |
|
|
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)
|
22/08/2024 |
| 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 Yet Recruiting |
| 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
|
There
are many studies that proves safety and high efficacy of LMA
protector in laparoscopic surgery and none for LMA
Blockbuster. We aim to compare the efficacy of LMA Protector vs LMA Blockbuster in laparoscopic surgeries. Both airway devices are newer airway devices with suggested adequate oropharyngeal seal capacity, preformed curved structure for ease of insertion, inflatable airway cuff, wider airway tube for endotracheal intubation, if needed; large bore gastric tube passage for deflation of stomach; Yet there is no literature comparing these two devices in laparoscopic surgeries. |