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

University of Malaya

Status: Invitation-only

Conditions: Nerve Condition

Treatments: Drug: Water for injection; Drug: Dexametasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07068048

MREC ID NO: 202456-13711

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Vocal cord paresis before surgery
• No consent
• Allergy towards dexamethasone
• Surgery involved neck dissection
• Retrosternal goitre

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Water for injection

Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy

Active Comparator group

Description:

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.

Treatment:

Drug: Dexametasone