Intra-operative Steroid Irrigation for Reducing Recurrent Laryngeal Nerve Palsy Post-thyroidectomy

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2026-08-30

Brief Summary

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The main aim of this study is to elucidate whether the topical irrigation of steroid during thyroid surgery can reduce the rate of recurrent laryngeal nerve palsy as majority of nerve dysfunction was due to neuropraxia to axonotmesis.

Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.

After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.

However for the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.

Both the otolaryngologist and patient are blinded throughout the whole study.

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Detailed Description

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Conditions

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Nerve Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intra-operative Water for Injection for Irrigation for Post-thyroidectomy

For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.

Group Type PLACEBO_COMPARATOR

Water for injection

Intervention Type DRUG

For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.

Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy

Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.

After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.

Group Type ACTIVE_COMPARATOR

Dexametasone

Intervention Type DRUG

Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.

After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.

Interventions

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Dexametasone

Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.

After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.

Intervention Type DRUG

Water for injection

For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The target population are patients who scheduled for thyroidectomy (include both total or hemithyroidectomy) under UMMC
* Age between 18 years old till 80 years old