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Not yet recruitingNCT07913841LMA-HYPOTHUpdated Nov 3, 2026

Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery

An interventional study of i-gel Supraglottic Airway Device and Endotracheal Tube in Perioperative Hypothermia and Hernia, Inguinal, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study aims to compare the effects of a laryngeal mask airway (i-gel) and an endotracheal tube on perioperative hypothermia in patients undergoing laparoscopic inguinal hernia surgery. The primary outcome is the incidence of hypothermia, defined as a core body temperature below 36°C, at the end of surgery. The study will also evaluate perioperative temperature changes and relevant postoperative outcomes between the two airway management groups.

Read the detailed description

Perioperative hypothermia is a common concern during general anesthesia and surgery. Maintaining normothermia is important for patient safety and postoperative recovery. Airway management techniques may be associated with differences in perioperative heat loss; however, their effects on body temperature in patients undergoing laparoscopic inguinal hernia surgery require further investigation.

This study is designed to compare the effects of a laryngeal mask airway (i-gel) and an endotracheal tube on perioperative hypothermia in patients undergoing laparoscopic inguinal hernia surgery under general anesthesia.

Eligible patients will be allocated to one of two groups according to the airway management technique: the i-gel group or the endotracheal tube group. Perioperative body temperature will be monitored, and the incidence of hypothermia, defined as a core body temperature below 36°C at the end of surgery, will be assessed as the primary outcome.

Additional perioperative and postoperative outcomes, including changes in body temperature and the occurrence and severity of shivering, will be evaluated and compared between the groups.

The findings may help clarify whether the choice of airway management device is associated with differences in perioperative temperature regulation in patients undergoing laparoscopic inguinal hernia surgery.

02

Conditions studied

  • Perioperative Hypothermia
  • Hernia, Inguinal

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Keywords

  • Perioperative Hypothermia
  • Laparoscopic Inguinal Hernia Surgery
  • Endotracheal Tube
  • Laryngeal Mask Airway
  • Postoperative Shivering
03

In context

Hernia, Inguinal

567 studies on the registry are indexed under Hernia, Inguinal; 80 are open to participants now.

This study's planned enrollment of 256 is above the median of 90 across 420 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 108 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18-65 years.
  • Male or female.
  • Scheduled for elective laparoscopic inguinal hernia repair.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) between 18 and 30 kg/m².
  • Willing to undergo general anesthesia.
  • Providing written informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Requirement for emergency surgery.
  • ASA physical status IV or higher.
  • BMI below 18 kg/m² or above 30 kg/m².
  • Known upper airway anatomical abnormalities or a history of difficult airway management.
  • High risk of aspiration.
  • Known esophageal disease or gastric emptying disorder.
  • History of malignant hyperthermia.
  • Baseline core body temperature below 36°C or above 37.5°C.
  • Active infection or fever in the preoperative period.
  • Thyroid disease or endocrine/metabolic disorders that may significantly affect body temperature.
  • Use of medications that may affect perioperative body temperature.
  • Communication or cognitive impairment that may prevent adherence to the study protocol.
  • Unplanned additional surgical procedures during surgery.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
256 participants (estimated)

Study arms

  • Experimental
    i-gel Group

    Patients will undergo general anesthesia with an i-gel supraglottic airway device for airway management during laparoscopic inguinal hernia surgery. Perioperative body temperature will be monitored, and the incidence of hypothermia will be assessed.

    Device: i-gel Supraglottic Airway Device

  • Experimental
    Endotracheal Tube Group

    Patients will undergo general anesthesia with an endotracheal tube for airway management during laparoscopic inguinal hernia surgery. Perioperative body temperature will be monitored, and the incidence of hypothermia will be assessed.

    Device: Endotracheal Tube

Interventions

  • Devicei-gel Supraglottic Airway Device

    Use of an i-gel supraglottic airway device for airway management during general anesthesia in laparoscopic inguinal hernia surgery.

  • DeviceEndotracheal Tube

    Use of an endotracheal tube for airway management during general anesthesia in laparoscopic inguinal hernia surgery.

06

What researchers measure

Primary outcomes

  1. Incidence of Perioperative Hypothermia at the End of Surgery

    The proportion of patients with a core body temperature below 36°C at the end of surgery will be compared between the i-gel and endotracheal tube groups.

    Time frame: At the end of surgery

Secondary outcomes

  1. Change in Core Body Temperature During Surgery

    Perioperative changes in core body temperature will be compared between the i-gel and endotracheal tube groups.

    Time frame: From the beginning to the end of surgery

  2. Incidence and Severity of Postoperative Shivering

    The incidence and severity of postoperative shivering will be assessed and compared between the two groups. Shivering severity will be graded as none, mild, moderate, or severe.

    Time frame: During the postoperative period

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07913841
Responsible party
Dilek Yamac (M.D., Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey) — Principal investigator
First posted
Nov 3, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Feb 15, 2027 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Dilek M Metin Yamac, MD
Contact
ddilekmetin@hotmail.com
+905054959792
Dilek Yamac, MD
study chair · Sultan 2. Abdulhamid Han Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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