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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654184
• Other study ID #: IRB000087118
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2016
• Last updated: November 4, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 8 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• supine position
Anesthesia induction with sevoflurane for the patient while he is in supine position.
• Right lateral position
Anesthesia induction with sevoflurane for the patient while he is in right lateral position.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction time	The time from starting induction of anesthesia until successful insertion of the LMA (seconds)	an expected 30 minutes	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Heart rate	Heart rate "beats per minute"	Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes	Yes
Secondary	Oxygen saturation	Oxygen saturation %	Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes	Yes