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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

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 - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/089928
Enrollment
66
Registered
2025-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N00-N99- Diseases of the genitourinary system

Interventions

Intervention1: 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 postopera

Sponsors

Pt JNM Medical college Raipur CG
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Patient refusal BMI more than 35 kg/m 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

Design outcomes

Primary

MeasureTime frame
To determine change in oropharyngeal leak pressure To evaluate ventilator parameters post insertionTimepoint: 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

MeasureTime frame
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) Timepoint: 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.

Countries

India

Contacts

Public ContactDr Pratibha jain shah

Pt JNM medical college

prati_jain@rediffmail.com9827276620

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026