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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
Holy Family Hospital, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 8, 2021
    Last Updated
    February 11, 2021
    Sponsor
    Holy Family Hospital, Pakistan
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    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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