Comparison of tracheal intubation and I-GEL in gynecology laparoscopic surgery under general anesthesia

A comparative study between endotracheal tube and I-GEL in gynecological laparoscopic surgeries under general anesthesia; A double blind clinical trial study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170314033069N6

Enrollment

Registered

2023-08-07

Start date

2023-08-23

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Comparison of two methods of tracheal intubation and I-GEL in gynecology laparoscopic surgery under general anesthesia. Therapeutic (nonsurgical) and rehabilitative anesthesiology devices associated with adverse incidents

Interventions

Intervention 1: Intervention group 1: In the endotracheal tube group, after the laryngoscopy of the patient by the anesthesiologist, the patient will be intubated with an appropriate size 7 or 7.5 tra

Eligibility

Sex/Gender

Female

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Elective laparoscopic surgeries Full fasting time of 8 hours No history of reflux American Society of Anesthesiologists (ASA) I,II Age range between 18-55 years The duration of the operation is less than two hours Body mass index (BMI) range between 25-35 kg.m2

Exclusion criteria

Exclusion criteria: Having any pathological problems in the neck and upper airway Patients at high risk for aspiration (Hiatus hernia , gastroesophageal reflux) Failure to open the mouth more than 2.5 centimeter Emergency surgery Patients with non-observance of standard times for liquids and solids (2 hours before the operation of clear liquids, 6-7 hours of solid foods)

Design outcomes

Primary

Measure	Time frame
Difficulty of establishing the airway. Timepoint: 3 minutes after induction of anesthesia. Method of measurement: Number of attempts to establish the airway.;Surgeon's satisfaction with the operation field in terms of gastric dilatation. Timepoint: After surgery. Method of measurement: Scoring from 0 (an empty stomach) to 10 (a fully distended stomach).;Postoperative complications. Timepoint: After surgery. Method of measurement: Observation.;Airway pressure. Timepoint: After establishing the airway. Method of measurement: Ventilator.	—

Measure

Time frame

Difficulty of establishing the airway. Timepoint: 3 minutes after induction of anesthesia. Method of measurement: Number of attempts to establish the airway.;Surgeon's satisfaction with the operation field in terms of gastric dilatation. Timepoint: After surgery. Method of measurement: Scoring from 0 (an empty stomach) to 10 (a fully distended stomach).;Postoperative complications. Timepoint: After surgery. Method of measurement: Observation.;Airway pressure. Timepoint: After establishing the airway. Method of measurement: Ventilator.

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Secondary

Measure	Time frame
Hemodynamic changes. Timepoint: Five stations (before pneumoperitoneum, 15 minutes after pneumoperitoneum, 30 minutes after pneumoperitoneum, immediately after gas release and 15 minutes after gas release). Method of measurement: Monitoring.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Gelareh Biazar

Rasht University of Medical Sciences

gelarehbiazar1386@gmail.com+98 13 3332 9524

Outcome results

None listed

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