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

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ClinicalTrials.gov Identifier: NCT02654184
Recruitment Status : Completed
First Posted : January 13, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Sayed Kaoud Abd-Elshafy, Assiut University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Procedure: supine position Procedure: Right lateral position Phase 2

Detailed Description:
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%).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Right Lateral Positioning and Its Effect on Induction of General Anesthesia for Children
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Supine group
Anesthesia induction with sevoflurane for the patient while he is in supine position.
 Procedure: supine position
Anesthesia induction with sevoflurane for the patient while he is in supine position.
Active Comparator: Right lateral group
Anesthesia induction with sevoflurane for the patient while he is in right lateral position position.
 Procedure: Right lateral position
Anesthesia induction with sevoflurane for the patient while he is in right lateral position.


Outcome Measures
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Primary Outcome Measures :
  1. Induction time [ Time Frame: an expected 30 minutes ]
    The time from starting induction of anesthesia until successful insertion of the LMA (seconds)


Secondary Outcome Measures :
  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 %


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654184


Locations
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Egypt
Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: sayed abd elshafy, MD associate professor
More Information
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Responsible Party: Sayed Kaoud Abd-Elshafy, Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT02654184    
Other Study ID Numbers: IRB000087118
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sayed Kaoud Abd-Elshafy, Assiut University:
Right lateral
Induction
Children
Anesthesia