| CTRI Number |
CTRI/2025/06/089275 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of postoperative sore throat following two type of airway device insertion in laparoscopic day care surgery |
|
Scientific Title of Study
|
Evaluation of Second-generation laryngeal mask airway (LMA Protector) for laparoscopic surgeries – A Randomized Controlled Trial
|
| 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. Subodh Kumar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Room No.- 434, Surgical Block, AIIMS,New Delhi
South
DELHI
110029
India |
| Phone |
09793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Subodh Kumar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Room No.- 434, Surgical Block, AIIMS,New Delhi
South
DELHI
110029
India |
| Phone |
09793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Subodh Kumar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Room No.- 434, Surgical Block, AIIMS,New Delhi
South
DELHI
110029
India |
| Phone |
09793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
ALL Institute of Medical Sciences,Ansari Nagar, Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SUBODH KUMAR |
All India Institute of Medical Sciences |
Operation theatre,Surgical and Mother child block, AIIMS, Ansari Nagar , New Delhi
South
DELHI |
09793184350
subodh.08aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS INSTITUTE ETHICS COMICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AmbuAuraGain |
it is an airway device that will remain inserted during surgical duration of around 3 hr |
| Intervention |
LMA Protector |
It is an airway device that will be there till during surgical duration of around 3 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age more thab 18 years
Patient for day care laparoscopic surgeries |
|
| ExclusionCriteria |
| Details |
Unwillingness to provide consent
ASA 1 and 2
Body mass index more than 35 kg/m2
Patients with known risk factors for aspiration like GERD.
|
|
|
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 |
| Incidence and severity of postoperative sore throat or pharyngodynia |
1 hr after Supraglottic airway device removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal leak Pressure |
After successful supraglottic airway device insertion |
| To compare the insertion time and number of attempts required for insertion between the two groups |
3 Minutes after induction |
| To compare change in intracuff pressure |
after induction, 5 minutes after pneumoperitoneum, 5 minutes after stopping pneumoperitoneum and at the end of surgery |
| 3. To compare respiratory mechanics peak airway pressure (Ppeak), plateau airway pressure (Pplat), PEEP, set TV (TV set), actual TV (TV act) |
after induction, 5 minutes after pneumoperitoneum, 5 minutes after stopping pneumoperitoneum and at the end of surgery |
To compare dysphagia and post operative nausea vomiting between the two groups.
|
1 hr after surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/07/2025 |
| 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="2"
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
|
General anaesthesia is widely practiced for laparoscopic abdominal surgery as pneumoperitoneum increases the risk of pulmonary aspiration., and this typically facilitated using an endotracheal tube (ETT) for airway management. But many of these laparoscopic surgeries are day care surgeries and used of ETT in these cases can lead to cumbersome postoperative pharyngodynia thereby increasing the duration of hospital stay and thereby increasing the health care cost. Hence now a days supraglottic airway devices (SGA) are preferred over ETT in these daycare cases because of less incidence of post operative pharyngodynia. However still many cases postoperative pharyngodynia occurs despite using second generation SGA because of variable intracuff pressure of SGA perioperatively. This change in intracuff pressure occurs due to change in patient positioning and creation of pneumoperitoneum perioperatively. Recently introduced The LMA Protector has dual gastric access and integrates “Second Seal Technology/second generation LMA” to secure the distal tip at the upper oesophageal sphincter. In this way an oesophageal seal is facilitated, and the respiratory tract is isolated from the digestive tract.[3] It also has inbuilt color-coded continuous cuff pressure monitoring system. Despite these developments, the scarcity of prospective research examining the suitability of different second-generation SGA which will cause less postoperative pharyngodynia and decrease hospital stay in day care surgery underscores the need for further investigation. Therefore, this study aims to evaluate the feasibility and safety of employing two second-generation SGA namely LMA Protector and Ambu AuraGain in patients undergoing laparoscopic surgeries, addressing a critical gap in the literature, and informing clinical practice regarding optimal airway management strategies in this context. |