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Completed

NCT Number: NCT02654184

Right Lateral Positioning and Its Effect on Induction of General Anesthesia for Children

The quality of induction with sevoflurane, along with its ability to generate optimal conditions for Laryngeal Mask Airway (LMA) insertion without supplemental opioids or muscle relaxants, has also been well documented. An ideal inhalation induction technique besides being rapid and comfortable for the patient should be economical. To achieve rapidity, use of vital capacity breaths with 8% sevoflurane is a more popular method of induction compared with the conventional incremental induction.

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Key information

Conditions

Anesthesia

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

About this study

100 pediatric patients (age range, 1 to 8 years) scheduled for lower abdominal surgery under anesthesia will be included. All children in both groups will be premedicated with midazolam, 0.5 mg/kg orally, about 30 minutes before the induction of anesthesia. A parent or guardian accompanied the child into the operating room to allow the child to remain calm and cooperative for inhalation induction. Before induction, pulse oximetry and electrocardiogram monitoring will be attached. For each group, inhalation induction was initiated using a face mask using "tidal volume" and "vital capacity" breathing in high sevoflurane concentration (8%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 1 years to 8 years
  • Children with ASA class I/II and their willingness to participate in the study

Exclusion criteria

  • Known seizure disorder
  • Craniofacial abnormalities/difficult airway
  • Cardiopulmonary or neuromuscular defects
  • Hepatic or renal insufficiency
  • Expected difficult intravenous (IV) cannulation (eg, dark complexion, obese)
  • Catching colds during the past four weeks

Treatment and study plan

Supine position

Procedure

Anesthesia induction with sevoflurane for the patient while he is in supine position.

Right lateral position

Procedure

Anesthesia induction with sevoflurane for the patient while he is in right lateral position.

Primary outcomes

  1. Induction time

    Time frame: an expected 30 minutes

    The time from starting induction of anesthesia until successful insertion of the LMA (seconds)

Secondary outcomes

  1. LMA trials (Number of patients in each group required insertion of an LMA more than once)

    Time frame: an expected 60 minutes

    Number of patients in each group required insertion of an LMA more than once

  2. Blood pressure

    Time frame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes

    Systolic, diastolic and mean blood pressure "mm Hg"

  3. Heart rate

    Time frame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes

    Heart rate "beats per minute"

  4. Oxygen saturation

    Time frame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes

    Oxygen saturation %

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2016
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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