NCT02654184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

January 10, 2016

Last Update Submit

November 4, 2016

Conditions

Anesthesia

Keywords

Right lateralInductionChildrenAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Induction time

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

    an expected 30 minutes

Secondary Outcomes (4)

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

    an expected 60 minutes

  • Blood pressure

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

  • Heart rate

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

  • Oxygen saturation

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

Study Arms (2)

Supine group

ACTIVE COMPARATOR

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

Procedure: supine position

Right lateral group

ACTIVE COMPARATOR

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

Procedure: Right lateral position

Interventions

supine positionPROCEDURE

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

Supine group
Right lateral positionPROCEDURE

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

Right lateral group

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • sayed abd elshafy, MD

    associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

First Submitted

January 10, 2016

First Posted

January 13, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

EG(1)