Comparing the efficacy of Baska mask versus Proseal laryngeal mask in during gynecological laparoscopic surgery

Efficacy of baska mask versus proseal laryngeal mask in airway protection during gynecological laparoscopic surgery. A randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202503561236628

Enrollment

100

Registered

2025-03-10

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Ear, Nose and Throat Respiratory laparoscopic surgeries Anaesthesia

Interventions

PL Group Proseal laryngeal mask group

BM Group Baska mask

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Female patients Undergoing elective gynecological laparoscopic surgeries under general anesthesia ASA status l-ll

Exclusion criteria

Exclusion criteria: Weight 35 kg/m2 History of hiatus hernia History of gastro-esophageal reflux disease Neck tumors or large scars Cervical spine pathology or fracture Upper airway pathology or obstruction Preoperative sore throat Predicted difficult airway Planned operation time > 4 h.

Design outcomes

Primary

Measure	Time frame
Adequate airway seal will be measured with the patient’s head and neck in the neutral position after closing the adjustable pressure limiting valve with a fresh gas flow of 6 L/min, noting the airway pressure at equilibrium. At this point, gas leakage will be heard at the mouth, at the epigastrium (epigastric auscultation) or coming out of the drainage tube. The maximum pressure allowed was 40 cm H2O	—

Measure

Time frame

Adequate airway seal will be measured with the patient’s head and neck in the neutral position after closing the adjustable pressure limiting valve with a fresh gas flow of 6 L/min, noting the airway pressure at equilibrium. At this point, gas leakage will be heard at the mouth, at the epigastrium (epigastric auscultation) or coming out of the drainage tube. The maximum pressure allowed was 40 cm H2O

—

Secondary

Measure	Time frame
Number of attempts of insertion: the proper insertion of the EGAD was confirmed by the detection of expired carbon dioxide by capnography and adequate chest inflation, three insertion attempts were allowed. Each ‘attempt’ is defined as re-insertion of the EGAD into the mouth;The ease of insertion which will be graded from 1-3 degrees (1= easy from the first attempt, 2=difficult as need more than one attempt, 3= impossible and failed to be inserted);Duration of insertion: interval from when the study investigator open the mouth of the patient and start insertion of the EGAD to first CO2 trace.;Blood staining of the device;Displacement of the device;Vomiting;Pharyngo-laryngeal discomfort	—

Measure

Time frame

Number of attempts of insertion: the proper insertion of the EGAD was confirmed by the detection of expired carbon dioxide by capnography and adequate chest inflation, three insertion attempts were allowed. Each ‘attempt’ is defined as re-insertion of the EGAD into the mouth;The ease of insertion which will be graded from 1-3 degrees (1= easy from the first attempt, 2=difficult as need more than one attempt, 3= impossible and failed to be inserted);Duration of insertion: interval from when the study investigator open the mouth of the patient and start insertion of the EGAD to first CO2 trace.;Blood staining of the device;Displacement of the device;Vomiting;Pharyngo-laryngeal discomfort

—

Countries

Egypt

Contacts

Public ContactEzzeldin Fikry

Prof of anesthesia and intensive care and pain management Faculty of medicine AlAzhar University

ezzismail@yahoo.com0020100141823

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026