Comparison of Optic Nerve Sheath Diameter in Children Receiving Caudal Block According to Anesthetic Agents: Total Intravenous Anesthesia vs. Volatile Anesthesia

May 4, 2022 updated by: Yonsei University
Caudal block is commonly used for postoperative analgesia in paediatric patients. A higher volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only increase the level of cranial spread but also provide better quality and longer duration of analgesia in comparison with the conventional volume (1.0 ml/kg). However, caudal block with a high volume of local anaesthetic can increase intracranial pressure (ICP). Previous studies have shown that propofol anesthesia lowers ICP when compared with volatile anesthesia. Therefore, this study was designed to test if propofol can reduce the magnitude of ICP increase following caudal block when compared with a volatile anesthetic, sevoflurane. There is increasing evidence that optic nerve sheath diameter (ONSD) measured by ultrasonography correlates with degree of ICP and is able to detect intracranial hypertension. Therefore, ONSD will be measured as a surrogate of ICP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Equal number of patients are randomly assigned to the P or S group. The participants in the P and S group are anesthetized with propofol and sevoflurane, respectively. Irrespective of assigned group, all participants receive caudal block with 1.5 ml/kg of 0.15% ropivacaine (up to 30 ml per individual participant). All anesthetic procedures except for main anesthetic agent are the same in all participants. ONSD is measured at the following time points: before (T0), immediately after (T1), and 10 min (T2) and 30 min(T3) after caudal block. Two measurements of each optic nerve sheath are acquired in each eye. The mean value of the four measurements is considered as the ONSD at each time point.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Among children undergoing urological surgery, patients, 36 to 72-months-old
  • Body weight less than 20 kg (The limit on body weight is set because the maximum volume of local anaesthetic for caudal block in children is restricted to 30 ml.)
  • Treatment plan for caudal block for analgesia, are enrolled.

Exclusion Criteria:

  • Symptoms or signs of spinal anomalies or infection at the sacral region
  • Coagulopathy
  • Increased ICP
  • Ophthalmic diseases
  • History of increased ICP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group P
The participants in the group P are anesthetized with propofol.
Drug: Propofol
The participants in the group P are anesthetized with propofol
Active Comparator: group S
The participants in the group S are anesthetized with sevoflurane.
Drug: Sevoflurane
The participants in the group S are anesthetized with sevoflurane.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ONSD
Time Frame: before (T0) caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
before (T0) caudal block.
ONSD
Time Frame: immediately after (T1) caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
immediately after (T1) caudal block.
ONSD
Time Frame: 10 minutes (T2) after caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
10 minutes (T2) after caudal block.
ONSD
Time Frame: 30 minutes (T3) after caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
30 minutes (T3) after caudal block.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The variables affecting ICP : Heart rate (beats per minute)
Time Frame: before (T0) caudal block.
before (T0) caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Time Frame: immediately after (T1) caudal block.
immediately after (T1) caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Time Frame: 10 minutes (T2) after caudal block.
10 minutes (T2) after caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Time Frame: 30 minutes (T3) after caudal block.
30 minutes (T3) after caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Time Frame: before (T0) caudal block.
before (T0) caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Time Frame: immediately after (T1) caudal block.
immediately after (T1) caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Time Frame: 10 minutes (T2) after caudal block.
10 minutes (T2) after caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Time Frame: 30 minutes (T3) after caudal block.
30 minutes (T3) after caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Time Frame: before (T0) caudal block.
before (T0) caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Time Frame: immediately after (T1) caudal block.
immediately after (T1) caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Time Frame: 10 minutes (T2) after caudal block.
10 minutes (T2) after caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Time Frame: 30 minutes (T3) after caudal block.
30 minutes (T3) after caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Time Frame: before (T0) caudal block.
before (T0) caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Time Frame: immediately after (T1) caudal block.
immediately after (T1) caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Time Frame: 10 minutes (T2) after caudal block.
10 minutes (T2) after caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Time Frame: 30 minutes (T3) after caudal block.
30 minutes (T3) after caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Time Frame: before (T0) caudal block.
before (T0) caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Time Frame: immediately after (T1) caudal block.
immediately after (T1) caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Time Frame: 10 minutes (T2) after caudal block.
10 minutes (T2) after caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Time Frame: 30 minutes (T3) after caudal block.
30 minutes (T3) after caudal block.
The variables affecting ICP : Body temperature (℃)
Time Frame: before (T0) caudal block.
before (T0) caudal block.
The variables affecting ICP : Body temperature (℃)
Time Frame: immediately after (T1) caudal block.
immediately after (T1) caudal block.
The variables affecting ICP : Body temperature (℃)
Time Frame: 10 minutes (T2) after caudal block.
10 minutes (T2) after caudal block.
The variables affecting ICP : Body temperature (℃)
Time Frame: 30 minutes (T3) after caudal block.
30 minutes (T3) after caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Time Frame: before (T0) caudal block.
before (T0) caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Time Frame: immediately after (T1) caudal block.
immediately after (T1) caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Time Frame: 10 minutes (T2) after caudal block.
10 minutes (T2) after caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Time Frame: 30 minutes (T3) after caudal block.
30 minutes (T3) after caudal block.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2020-0061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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