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

Phase 2

Completed

• Conditions: Anesthesia
• Interventions: Procedure: supine position; Procedure: Right lateral position

• Registration Number: NCT02654184
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-10
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-13
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supine group	supine position	Anesthesia induction with sevoflurane for the patient while he is in supine position.
Right lateral group	Right lateral position	Anesthesia induction with sevoflurane for the patient while he is in right lateral position position.

Primary Outcome Measures

Name	Time	Method
Induction time	an expected 30 minutes	The time from starting induction of anesthesia until successful insertion of the LMA (seconds)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt