| CTRI Number |
CTRI/2025/07/089928 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare the Safety and Effectiveness of Two Airway Devices (Supreme LMA and I-GEL) with Endotracheal Tube in Patients Undergoing Hysterolaparoscopic Surgery Under General Anaesthesia |
|
Scientific Title of Study
|
Evaluation of safety and efficacy of Supreme LMA and I-GEL as compared to endotracheal tube in hysterolaparoscopic surgeries under general anaesthesia: An Interventional 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 Ogirala Keerthana |
| Designation |
PG Student |
| Affiliation |
Pt JNM medical college |
| Address |
Department of anaesthesia
Pt JNM medical college
Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9493639863 |
| Fax |
|
| Email |
keerthanaogirala99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha jain shah |
| Designation |
Head of the department |
| Affiliation |
Pt JNM medical college |
| Address |
Department of anaesthesia
Pt JNM medical college
Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha jain shah |
| Designation |
Head of the department |
| Affiliation |
Pt JNM medical college |
| Address |
Department of anaesthesia
Pt JNM medical college
Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9827276620 |
| Fax |
|
| Email |
prati_jain@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia and pain medicine
Pt JNM medical college
Raipur
492001 |
|
|
Primary Sponsor
|
| Name |
Pt JNM Medical college Raipur CG |
| Address |
Department of anaesthesia and Pain medicine, Pt JNM Medical college, opposite jail road, Raipur, Chhattisgarh, India, Pin code- 492001
|
| 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 Keerthana |
Dr Bhimrao Ambedkar memorial hospital, Raipur, Chhattisgarh |
Ayushman laparoscopic OT
Department of anaesthesia
Raipur
Chhattisgarh
Raipur
CHHATTISGARH |
9493639863
keerthanaogirala99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Pt JNM Medical college Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endotracheal tube |
Inserted after induction of general anaesthesia and cuff inflated with recommended air volume and removed postoperatively |
| Intervention |
I-Gel |
Airway device inserted orally after induction of general anaesthesia and removed post operatively
Single use during surgery |
| Intervention |
Supreme Laryngeal mask airway (LMA) |
Airway device inserted orally after induction of general anaesthesia and cuff will be inflated with the recommended air volume and removed postoperatively
Single use during the surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
18-60 years female with ASA Grade I,II and III undergoing elective hysterolaparoscopic surgical procedure under general anaesthesia with expected duration of surgery less than 2 hours |
|
| ExclusionCriteria |
| Details |
Patient refusal
BMI more than 35 kg/m²
Mallampati class 3 & 4
Inter incisor distance less than 20mm
Thyromental distance less than 65mm
Oropharyngeal pathology
Restricted neck mobility or any cervical spine pathology
History of gastro esophageal reflux disease, hiatus hernia
Obstructive sleep apnea
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine change in oropharyngeal leak pressure
To evaluate ventilator parameters post insertion |
Oropharyngeal leak pressure will be determined after securing the airway
Inspired tidal volume, expired tidal volume and peak airway pressure will be recorded at 1 minute, 3 minutes, 5 minutes, 10 minutes and there after every 20 minutes and 30 minutes.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record hemodynamic responses.
To assess ease of insertion and time to establish effective ventilation
To determine time taken for gastric tube insertion.
To evaluate any peri-operative complications (Blood staining of device, dental trauma, gastric insufflations, desaturation, laryngospasm, dysphagia)
|
Hemodynamic changes are recorded every 1 minute, 3 minutes, 5 minutes, 10 minutes and every 20 minutes and 30 minutes
Ease of insertion will be defined on 5 point scale (1 = easy, 2 = not so easy, 3 = difficult, 4 = very difficult, 5 = impossible)
Time taken for gastric tube insertion will be recorded from the time the device (either the LMA Supreme or the i-gel) is correctly placed until the gastric catheter is successfully inserted.
The patient will be asked one hour later and the following day to report any sore throat, hoarseness of voice or dysphagia. These symptoms will graded into mild, moderate or severe.
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/07/2025 |
| 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="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
Modification(s)
|
This interventional study aims to evaluate and compare the safety and efficacy of two supraglottic airway devices — LMA Supreme and i-gel — with the conventional endotracheal tube (ETT) in patients undergoing hysterolaparoscopic surgeries under general anaesthesia. The study will assess parameters including ease of insertion, hemodynamic stability, oxygenation and ventilation efficacy, airway complications, and postoperative outcomes. A total of 66 patients will be randomized into three groups to receive either the LMA Supreme, i-gel, or ETT during surgery. All patients will be monitored intraoperatively and postoperatively for airway-related complications, insertion time, oropharyngeal leak pressure, and other relevant clinical indicators. The findings of this study will help determine whether these less invasive airway devices can serve as safe and effective alternatives to endotracheal intubation in laparoscopic gynecological procedures. |