Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-operative Water for Injection for Irrigation for Post-thyroidectomy | Placebo Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexametasone | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post thyroidectomy vocal cord assessment will be performed by otolaryngologist within 3 weeks after surgery by using indirect larygoscopy, to look for any vocal cord palsy | if both the vocal cord mobile equally with no phonation gap, indicated no vocal cord palsy if any of the vocal cord paralysed with phonation gap, indicated vocal cord palsy | Three week post surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMMC | Petaling Jaya | Selangor | 50603 | Malaysia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2024 | Jun 23, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2024 | Jul 13, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014867 | Water |
| D007267 | Injections |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Water for injection | 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. |
|
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |