Skip to main content
OpenTrials
Completed

NCT Number: NCT04415905

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caudal Block for Postoperative Analgesia

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

The participants in the group P are anesthetized with propofol

Sevoflurane

Drug

The participants in the group S are anesthetized with sevoflurane.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. The variables affecting ICP : Heart rate (beats per minute)

    Time frame: before (T0) caudal block.

  2. The variables affecting ICP : Heart rate (beats per minute)

    Time frame: immediately after (T1) caudal block.

  3. The variables affecting ICP : Heart rate (beats per minute)

    Time frame: 10 minutes (T2) after caudal block.

  4. The variables affecting ICP : Heart rate (beats per minute)

    Time frame: 30 minutes (T3) after caudal block.

  5. The variables affecting ICP : Mean arterial pressure (mmHg)

    Time frame: before (T0) caudal block.

  6. The variables affecting ICP : Mean arterial pressure (mmHg)

    Time frame: immediately after (T1) caudal block.

  7. The variables affecting ICP : Mean arterial pressure (mmHg)

    Time frame: 10 minutes (T2) after caudal block.

  8. The variables affecting ICP : Mean arterial pressure (mmHg)

    Time frame: 30 minutes (T3) after caudal block.

  9. The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)

    Time frame: before (T0) caudal block.

  10. The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)

    Time frame: immediately after (T1) caudal block.

  11. The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)

    Time frame: 10 minutes (T2) after caudal block.

  12. The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)

    Time frame: 30 minutes (T3) after caudal block.

  13. The variables affecting ICP : End-tidal sevoflurane concentration (volume %)

    Time frame: before (T0) caudal block.

  14. The variables affecting ICP : End-tidal sevoflurane concentration (volume %)

    Time frame: immediately after (T1) caudal block.

  15. The variables affecting ICP : End-tidal sevoflurane concentration (volume %)

    Time frame: 10 minutes (T2) after caudal block.

  16. The variables affecting ICP : End-tidal sevoflurane concentration (volume %)

    Time frame: 30 minutes (T3) after caudal block.

  17. The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)

    Time frame: before (T0) caudal block.

  18. The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)

    Time frame: immediately after (T1) caudal block.

  19. The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)

    Time frame: 10 minutes (T2) after caudal block.

  20. The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)

    Time frame: 30 minutes (T3) after caudal block.

  21. The variables affecting ICP : Body temperature (℃)

    Time frame: before (T0) caudal block.

  22. The variables affecting ICP : Body temperature (℃)

    Time frame: immediately after (T1) caudal block.

  23. The variables affecting ICP : Body temperature (℃)

    Time frame: 10 minutes (T2) after caudal block.

  24. The variables affecting ICP : Body temperature (℃)

    Time frame: 30 minutes (T3) after caudal block.

  25. The variables affecting ICP : Peak inspiratory pressure (mmHg)

    Time frame: before (T0) caudal block.

  26. The variables affecting ICP : Peak inspiratory pressure (mmHg)

    Time frame: immediately after (T1) caudal block.

  27. The variables affecting ICP : Peak inspiratory pressure (mmHg)

    Time frame: 10 minutes (T2) after caudal block.

  28. The variables affecting ICP : Peak inspiratory pressure (mmHg)

    Time frame: 30 minutes (T3) after caudal block.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.