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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: supine position; Procedure: Right lateral position

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction time	The time from starting induction of anesthesia until successful insertion of the LMA (seconds)	an expected 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LMA trials (Number of patients in each group required insertion of an LMA more than once)	Number of patients in each group required insertion of an LMA more than once	an expected 60 minutes
Blood pressure	Systolic, diastolic and mean blood pressure "mm Hg"	Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Heart rate	Heart rate "beats per minute"	Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Oxygen saturation	Oxygen saturation %	Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: sayed abd elshafy, MD, Associate professor

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 10, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 13, 2016

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Children; Anesthesia; Induction; Right lateral
• Other Study ID Numbers: IRB000087118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED