AnesthesiaPhase 2NCT02654184
Right Lateral Positioning and Its Effect on Induction of General Anesthesia for Children
A Phase 2 study testing supine position and Right lateral position in people with Anesthesia, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- supine position and Right lateral position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 years to 8 years
- Children with ASA class I/II and their willingness to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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%).
- Conditions
- Anesthesia
- Being tested
- supine position, Right lateral position
- Keywords
- Right lateral, Induction, Children, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supine positionProcedure or surgery
Anesthesia induction with sevoflurane for the patient while he is in supine position.
Right lateral positionProcedure or surgery
Anesthesia induction with sevoflurane for the patient while he is in right lateral position.
| Study group | Role | What they receive |
|---|---|---|
| Supine group | Active comparator | Anesthesia induction with sevoflurane for the patient while he is in supine position. Receives: Procedure: supine position |
| Right lateral group | Active comparator | Anesthesia induction with sevoflurane for the patient while he is in right lateral position position. Receives: Procedure: Right lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction time
The time from starting induction of anesthesia until successful insertion of the LMA (seconds)
Measured: an expected 30 minutes
Secondary outcomes (4)
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
Measured: an expected 60 minutes
Blood pressure
Systolic, diastolic and mean blood pressure "mm Hg"
Measured: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Heart rate
Heart rate "beats per minute"
Measured: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Oxygen saturation
Oxygen saturation %
Measured: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- sayed abd elshafy, MD, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654184
- Sponsor's protocol ID
- IRB000087118
- Status last verified
- Nov 2016
- First submitted
- 10 Jan 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Lateral Positioning and Its Effect on Induction of General Anesthesia for Children
- ClinicalTrials.gov ID
- NCT02654184
- Acronym / sponsor ID
- IRB000087118
- Conditions
- Anesthesia
- Keywords
- Right lateral, Induction, Children, Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine group | Active comparator | Procedure: supine positionAnesthesia induction with sevoflurane for the patient while he is in supine position. |
| Right lateral group | Active comparator | Procedure: Right lateral positionAnesthesia induction with sevoflurane for the patient while he is in right lateral position position. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 1 years to 8 years
- Children with ASA class I/II and their willingness to participate in the study
Key exclusion criteria (6 listed)
- Known seizure disorder
- Craniofacial abnormalities/difficult airway
- Cardiopulmonary or neuromuscular defects
- Hepatic or renal insufficiency
- Expected difficult intravenous (IV) cannulation (eg, dark complexion, obese)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supine positionAnesthesia induction with sevoflurane for the patient while he is in supine position. | Procedure or surgery | Supine group |
| Right lateral positionAnesthesia induction with sevoflurane for the patient while he is in right lateral position. | Procedure or surgery | Right lateral group |
Primary outcome
Induction time
Time frame: an expected 30 minutes
The time from starting induction of anesthesia until successful insertion of the LMA (seconds)
4 secondary outcomes
LMA trials (Number of patients in each group required insertion of an LMA more than once)
Time frame: an expected 60 minutes
Blood pressure
Time frame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Heart rate
Time frame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Oxygen saturation
Time frame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sayed abd elshafy, MD principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing supine position and Right lateral position in people with Anesthesia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction time (time frame: an expected 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.