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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-22

Study Completion Date

2022-03-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Caudal Block for Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are 2 groups according to the type of main anesthetic agent. P group are anesthetized with propofol, so are S group with sevoflurane.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Anesthesia machine and infusion pumps are shielded from assessors who measure ONSD.

Study Groups

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group P

The participants in the group P are anesthetized with propofol.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

The participants in the group P are anesthetized with propofol

group S

The participants in the group S are anesthetized with sevoflurane.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

The participants in the group S are anesthetized with sevoflurane.

Interventions

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Propofol

The participants in the group P are anesthetized with propofol

Intervention Type DRUG

Sevoflurane

The participants in the group S are anesthetized with sevoflurane.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No