| CTRI Number |
CTRI/2025/02/079980 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to Compare Endotracheal Tube and LMA Protector in patients posted for Laproscopic Cholecystectomy. |
|
Scientific Title of Study
|
COMPARISON OF PROTECTOR LMA AND ENDOTRACHEAL TUBE IN PATIENT UNDERGOING LAPROSCOPIC CHOLECYSTECTOMY: A RADOMISED CONTROLLED TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashutosh Ashok Mishra |
| Designation |
Anaesthesia Resident |
| Affiliation |
MM Institute of Medical Science and Research,Mullana,Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Science and Research MM(DU) CAMPUS, MULLANA, AMBALA, HARYANA.
Ambala
HARYANA
133207
India |
| Phone |
8090624782 |
| Fax |
|
| Email |
ashutosh.m0002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakesh kumar Anand |
| Designation |
Professor |
| Affiliation |
MM Institute of Medical Science and Research, Mullana, Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Science and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakesh kumar Anand |
| Designation |
Professor |
| Affiliation |
MM Institute of Medical Science and Research, Mullana, Ambala |
| Address |
Department of Anaesthesia, MM Institute of Medical Science and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, MM Institute of Medical Science and Research, Mullana, Ambala, Haryana,India. Pincode:133207 |
|
|
Primary Sponsor
|
| Name |
Dr Lakesh k Anand |
| Address |
Department of anaesthesia,1st floor, newbuilding,M.M.Institute of Medical Science and Research, Mullana, Ambala, Haryana, India. Pincode:133207 |
| Type of Sponsor |
Other [Self] |
|
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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 Ashutosh Ashok Mishra |
MM Institute of Medical Science and Research |
Department of anaesthesia, 2nd floor, old building, MMIMSR,Mullana, Ambala, Haryana, India. pincode: 133207
Ambala
HARYANA |
8090624782
ashutosh.m0002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MMIMSR, Mullana, Ambala, Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R10-R19||Symptoms and signs involving the digestive system and abdomen, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal tube |
Endotracheal tube of appropriate size will be used to secure airway after preoxygenation of 3 minutes |
| Comparator Agent |
LMA Protector |
LMA protector of appropriate size will be used to secure airway |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status I-II, Patients undergoing elective laparoscopic cholecystectomy surgeries requiring General anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Patients with a body mass index (BMI)more than 35 kg per meter square.
2.Patients with increased risk of regurgitation and aspiration of gastric content
3.Patients with distorted airway anatomy
4.Patients with upper respiratory tract infection
5.Patients with hepatic or renal insufficiency
6.Pregnant patients
7.Patients unable to understand the study protocol
8.Refusal of consent |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response (Heart rate and Blood pressure) |
Hemodynamic response (Heart rate and Blood pressure) will be recorded at fixed time intervals Preinduction, after induction with the LMA Protector or ETT, before pneumo-peritoneum 1, 5, 10 minutes after pneumoperitoneum after release of pneumoperitoneum during extubation and postoperatively at 0 hour (when patient is conscious, oriented and able to comprehend) and at 24 hours. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative laryngopharyngeal morbidity (Sore throat & dysphagia) |
Post extubation & after 24 hours |
|
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Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 3 |
|
Date of First Enrollment (India)
|
14/02/2025 |
| 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
|
Laparoscopic cholecystectomy is one of the commonly performed surgical procedure under general anaesthesia and is considered procedure of choice for cholelithiaisis. It is minimally invasive procedure that involves insufflation of the abdominal cavity with carbon dioxide. Laparoscopic cholecystectomy faces other challenges to anesthesiologist caused by increased intraabdominal pressure and abdominal distention due to pneumoperitoneum, compromised ventilation due to distended abdomen pushing diaphragm into thoracic cavity causing unfavorable hemodynamic response.
Control of Heart rate and blood pressure are important aspect to the anesthesiologist for the benefit of the patient.
The Endotracheal intubation has been considered as an ideal approach, However it has disadvantages like raised respiratory and hemodynamic response during intubation, pneumoperitoneum and extubation. post operative sore throat is also serious concern to prevent these complications laryngeal mask airway can be used as an alternative to endotracheal intubation for airway management and laparoscopic surgeries.
Amongst the supraglottic airway devices the LMA Protector is the most advanced, airway device available from teleflex. LMA Protector studied in Laparoscopic surgeries showed High oropharyngeal leak pressure and it could achieve effective ventilation and shown to be safe and effective in patients undergoing laparoscopic surgery.
Very limited literature is available regarding the use of LMA protector in laparoscopic surgery .Hence the present study is to compare the effectiveness of LMA Protector with ETT in patients undergoing laparoscopic cholecystectomy under general anesthesia while comparing hemodynamic response (Heart rate and blood pressure) and postoperative laryngopharyngeal morbidity( Sore throat and dysphagia). |