CTRI

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CTRI Number

CTRI/2025/11/097819 [Registered on: 21/11/2025] Trial Registered Prospectively

Last Modified On:

12/11/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of airways devices (I-gel and Endotracheal Tube) on Stomach Volume and Gut Recovery After Laparoscopic abdominal Surgery in Diabetic Patients.

Scientific Title of Study

Effect of I-gel versus endotracheal intubation on perioperative gastric volume and postoperative gastrointestinal recovery in diabetic patients undergoing laparoscopic abdominal surgeries: a 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	Shreya Saxena
Designation	Junior resident
Affiliation	Uttar Pradesh University of Medical Sciences
Address	room 116, rani laxmi bai girls hostel, UPUMS, Saifai, Etawah, Uttar pradesh, India, 206130 UPUMS, Saifai, Etawah Etawah UTTAR PRADESH 206130 India
Phone	9454285194
Fax
Email	myselfshreya20@gmail.com

Details of Contact Person
Scientific Query

Name	Usha Shukla
Designation	Professor and Head
Affiliation	Uttar Pradesh University of Medical Sciences
Address	Department of anaesthesiology ,UPUMS Etawah UTTAR PRADESH 206130 India
Phone	9412201915
Fax
Email	ushashukla1970@gmail.com

Details of Contact Person
Public Query

Name	Usha Shukla
Designation	Professor and Head
Affiliation	Uttar Pradesh University of Medical Sciences
Address	Department of anaesthesiology ,UPUMS Etawah UTTAR PRADESH 206130 India
Phone	9412201915
Fax
Email	ushashukla1970@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Uttarpradesh University of medical sciences
Address	Saifai, Etawah, Uttar Pradesh, 206130
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Shreya Saxena	Uttar Pradesh University of Medical sciences	Department of Anaesthesiology , UPUMS , Saifai , Etawah , Uttar Pradesh Etawah UTTAR PRADESH	9454285194 myselfshreya20@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee, Saifai, UP-206130, Uttar Pradesh University of Medical Sciences	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Endotracheal intubation	Direct laryngoscopy will be performed with an appropriate size Macintosh blade and Endotracheal tube (ETT) will be placed. The ETT will then be connected to the anesthesia workstation with previously assigned settings. The tracheal position of the ETT will be confirmed by 5-point auscultation, chest rise, and end tidal carbon dioxide readings.
Comparator Agent	I-gel	The appropriate size of I-Gel device will be inserted. The placement of I Gel will be confirmed by resistance to further distal movement, end tidal carbon dioxide readings, and effective chest wall movement. If satisfactory insertion is not achieved with three attempts, or there is respiratory embarrassment, the patient will be removed from the study after being intubated via direct laryngoscopy.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.patients undergoing Laproscopic abdominal surgeries 2.Body mass index between 18.5 to 24.9 kg per m2 3.American society of Anaesthesiologists physical status class 2 4.History of Diabetes mellitus for atleast 5 years or more with controlled blood sugar levels.

ExclusionCriteria

Details

1. Patient’s refusal
2. Baseline gastric volume more than 1ml per kg on the morning of surgery
3.Diagnosed cases of gastric esophageal reflux disease
4. Anticipated difficult airway
5. Chronic treatment with opioids, steroid, immunosuppresants, chemotherapy, drugs affecting gastric motility or gastric volume
6. Neurological or psychiatric conditions affecting gastric motility
7. Pregnancy

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Comparison of change in perioperative gastric volume using USG guided antral cross sectional area measurement in both the groups.	baseline (preoperative), just after securing airway, and at the end of surgery before extubation.

Secondary Outcome

Outcome	TimePoints
Comparison of Postoperative gastrointestinal recovery	Time to start clear fluids ( When patient restore atleast 2 bowel sounds per minute). Time to start Light diet ( When patient restore normal bowel sounds i.e., more than 5 sounds per minute). Time to First gas discharge ( flatus) Time to Achieve first bowel movement. All these parameters will be measured from the time of extubation.
Measurement of hemodynamic parameters- heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure (MAP).	At baseline (preoperative), just after securing airway, at pneumoperitoneum, and at end of surgery before extubation.
Measurement of intraoperative ventilatory parameters :Leak volume, leak fraction, Peak airway pressure, Plateau pressure, EtCO2.	Just after securing airway, at pneumoperitoneum, and at end of surgery before extubation
Degree of gastric distension	On insertion of laparoscope.
Postoperative events	In 24 hours after extubation

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

N/A

Date of First Enrollment (India)

01/12/2025

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="10"
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

The study will begin after approval from the Institutional Ethical Committee and registration with the Clinical Trials Registry – India (CTRI). After obtaining informed consent, patients will be randomly assigned to either Group A (endotracheal intubation) or Group B (I-Gel insertion) using a computer-generated random number table and opaque sealed envelopes for allocation concealment. Preoperative assessment will include antral cross-sectional area (CSA) measurement using ultrasound. Standardized general anesthesia will be administered, and airway management will follow group allocation. Ventilation settings will be consistent across groups, and intra-abdominal pressure and Trendelenburg tilt will be maintained as per surgical needs. Data collection will include antral CSA at three time points, hemodynamic parameters, intraoperative ventilatory parameters (leak volume, leak fraction, peak and plateau airway pressures, EtCO2), and gastrointestinal recovery indicators such as time to clear fluids, light diet, flatus, and bowel movement. Gastric distension will be graded by the surgeon using a 5-point Likert scale, and postoperative complications such as nausea, vomiting, and sore throat will be recorded for 24 hours. At the end of surgery, anesthesia will be discontinued and reversal agents administered, with removal of airway devices based on adequate signs of recovery.