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

NCT04415905 | Completed

• 1 other identifier: 4-2020-0061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caudal Block for Postoperative Analgesia

Keywords

Caudal block; Intracranial pressure; Propofol; Sevoflurane; Ultrasound

Outcome Measures

Primary Outcomes (4)

• ONSD

  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

  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

  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

  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 Outcomes (28)

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

  before (T0) caudal block.

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

  immediately after (T1) caudal block.

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

  10 minutes (T2) after caudal block.

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

  30 minutes (T3) after caudal block.

• The variables affecting ICP : Mean arterial pressure (mmHg)

  before (T0) caudal block.

Study Arms (2)

group P

EXPERIMENTAL

The participants in the group P are anesthetized with propofol.

Drug: Propofol

group S

ACTIVE COMPARATOR

The participants in the group S are anesthetized with sevoflurane.

Drug: Sevoflurane

Interventions

Propofol DRUG

The participants in the group P are anesthetized with propofol

group P

Sevoflurane DRUG

The participants in the group S are anesthetized with sevoflurane.

group S

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Anesthesia machine and infusion pumps are shielded from assessors who measure ONSD.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 4, 2020
• Study Start: June 22, 2020
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)