Deep Neuromuscular Blockade on Postoperative Pain

NCT ID: NCT06679569

Last Updated: 2025-05-13

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

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2026-11-07

Brief Summary

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This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.

Detailed Description

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Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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moderate neuromuscular blockade

Group Type ACTIVE_COMPARATOR

rocuronium 0.2 mg/kg/hr continuous infusion

Intervention Type DRUG

To maintain Train-of-four count 1 to 3 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.2 mg/kg/hr to achieve and sustain moderate neuromuscular blockade.

deep neuromuscular blockade

Group Type EXPERIMENTAL

rocuronium 0.6 mg/kg/hr continuous infusion

Intervention Type DRUG

To maintain Train-of-four count 0 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.6 mg/kg/hr to achieve and sustain deep neuromuscular blockade.

Interventions

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rocuronium 0.2 mg/kg/hr continuous infusion

To maintain Train-of-four count 1 to 3 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.2 mg/kg/hr to achieve and sustain moderate neuromuscular blockade.

Intervention Type DRUG

rocuronium 0.6 mg/kg/hr continuous infusion

To maintain Train-of-four count 0 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.6 mg/kg/hr to achieve and sustain deep neuromuscular blockade.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients aged over 2 months to under 7 years scheduled for laparoscopic surgery under general anesthesia.
* American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.

Exclusion Criteria

* Patients undergoing emergency surgery.
* Patients with chronic pain or currently taking analgesics for chronic pain.
* Known hypersensitivity to general anesthetic agents or analgesics.
* Patients with underlying cardiovascular disease.
* Patients with neuromuscular disorders.
* Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.
Minimum Eligible Age

2 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji-Hyun Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SNUCH

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Clinical Assistant

Role: CONTACT

82-2-2072-3664

Facility Contacts

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Clinical Assistant

Role: primary

82-2-2072-3664

Other Identifiers

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2410-015-1575

Identifier Type: -

Identifier Source: org_study_id

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