Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
Primary Purpose
Thyroid Diseases, Hypocalcemia, Vocal Cord Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Thyroid Diseases focused on measuring Thyroidectomy, Postoperative Hypocalcaemia, Postoperative Vocal cord dysfunction, Dexamethasone
Eligibility Criteria
Inclusion Criteria:
- Benign thyroid condition.
- Patients without any preoperative corrected hypocalcaemia and voice or vocal quality dysfunction.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone
Placebo
Arm Description
Patients with odd numbers were assigned to group A. 8 mg/2 ml dexamethasone was injected intravenously sixty minutes before the induction of anaesthesia
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.
Outcomes
Primary Outcome Measures
Hypocalcaemia
Hypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04752852
First Posted
February 8, 2021
Last Updated
February 11, 2021
Sponsor
Holy Family Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT04752852
Brief Title
Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
Official Title
Randomised Control Trial on the Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holy Family Hospital, Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases, Hypocalcemia, Vocal Cord Dysfunction
Keywords
Thyroidectomy, Postoperative Hypocalcaemia, Postoperative Vocal cord dysfunction, Dexamethasone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Patients with odd numbers were assigned to group A. 8 mg/2 ml dexamethasone was injected intravenously sixty minutes before the induction of anaesthesia
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
normal saline (0.9%)
Intervention Description
2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia
Primary Outcome Measure Information:
Title
Hypocalcaemia
Description
Hypocalcaemia was defined as a corrected serum calcium level of less than 2 mmol/L.
Time Frame
3 days
Title
Voice dysfunction
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Benign thyroid condition.
Patients without any preoperative corrected hypocalcaemia and voice or vocal quality dysfunction.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raheel Ahmad, FCPS
Organizational Affiliation
Holy Family Hospital Rawalpindi Pakistan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19092351
Citation
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.
Results Reference
background
PubMed Identifier
30989072
Citation
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.
Results Reference
background
PubMed Identifier
34473215
Citation
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.
Results Reference
derived
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Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
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