NCT04752852

Brief Summary

Total thyroidectomy for benign surgical pathologies is associated with risks related to temporary hypocalcaemia and vocal quality dysfunction. Dexamethasone, as an anti-inflammatory steroid, has been proposed to have a physiological effect on hypocalcaemia and voice quality. Investigators conducted a double-blinded controlled trial to assess the effect of preoperative dexamethasone on the vocal dysfunction and hypocalcaemia following thyroidectomy

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

5.9 years

First QC Date

February 8, 2021

Last Update Submit

February 11, 2021

Conditions

Thyroid DiseasesHypocalcemiaVocal Cord Dysfunction

Keywords

ThyroidectomyPostoperative HypocalcaemiaPostoperative Vocal cord dysfunctionDexamethasone

Outcome Measures

Primary Outcomes (2)

  • Hypocalcaemia

    Hypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L.

    3 days

  • Voice dysfunction

    Signs and symptoms of voice dysfunction at 24 hours after thyroidectomy. Voice dysfunction was defined on voice analogue score from 0-100. Participants with Voice Analogue Score of less than 50 were labelled as having voice dysfunction, and participants with score more than 50 were considered as normal.

    24 hours

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Patients with odd numbers were assigned to group A. 8 mg/2 ml dexamethasone was injected intravenously sixty minutes before the induction of anaesthesia

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Patients with even numbers were assigned to group B. Two millilitres (ml) normal saline (0.9%) was given intravenously 60 minutes before the induction of anaesthesia.

Drug: Placebo

Interventions

DexamethasoneDRUG

8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia

Dexamethasone
PlaceboDRUG

2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia

Also known as: normal saline (0.9%)
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Benign thyroid condition.
  • Patients without any preoperative corrected hypocalcaemia and voice or vocal quality dysfunction.

You may not qualify if:

  • Previous thyroid or neck surgery
  • Known vocal cord dysfunction on laryngoscopy
  • Hearing or voice problems
  • History of gastroesophageal reflux and stomach ulcer disease
  • Contraindications of steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.

    PMID: 19092351BACKGROUND

  • Kolahdouzan M, Iraj B, Eslamian M, Harandizadeh M, Meamar R. Preventive Effect of Dexamethasone Therapy on the Transient Hypoparathyroidism through Total Thyroidectomy. Iran J Otorhinolaryngol. 2019 Mar;31(103):73-80.

    PMID: 30989072BACKGROUND

  • Dhahri AA, Ahmad R, Rao A, Bhatti D, Ahmad SH, Ghufran S, Kirmani N. Use of Prophylactic Steroids to Prevent Hypocalcemia and Voice Dysfunction in Patients Undergoing Thyroidectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Oct 1;147(10):866-870. doi: 10.1001/jamaoto.2021.2190.

    PMID: 34473215DERIVED

MeSH Terms

Conditions

Thyroid DiseasesHypocalcemiaVocal Cord Dysfunction

Interventions

DexamethasoneSaline Solution

Condition Hierarchy (Ancestors)

Endocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte ImbalanceLaryngeal DiseasesRespiratory Tract DiseasesRespiration DisordersOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Raheel Ahmad, FCPS

    Holy Family Hospital Rawalpindi Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 12, 2021

Study Start

January 1, 2014

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02