Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction

• Sponsor: Holy Family Hospital, Pakistan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04752852
• Collaborator: (none)
• Enrollment: 192
• Arms: 2
• Actual Duration (Months): 78

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Thyroid Diseases; Hypocalcemia; Vocal Cord Dysfunction	Drug: Dexamethasone; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Randomised Control Trial on the Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone 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; 8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia
Placebo Comparator: Placebo 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; 2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia; Other Names: normal saline (0.9%)

Outcome Measures

Primary Outcome Measures

1. Hypocalcaemia [3 days]

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

2. Voice dysfunction [24 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Holy Family Hospital, Pakistan

Investigators

• Principal Investigator: Raheel Ahmad, FCPS, Holy Family Hospital Rawalpindi Pakistan

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Raheel Ahmad, Principal Investigator, Holy Family Hospital, Pakistan
• ClinicalTrials.gov Identifier: NCT04752852
• Other Study ID Numbers: 233/HFH12/14
• First Posted: Feb 12, 2021
• Last Update Posted: Feb 12, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raheel Ahmad, Principal Investigator, Holy Family Hospital, Pakistan: Thyroidectomy; Postoperative Hypocalcaemia; Postoperative Vocal cord dysfunction; Dexamethasone
• Additional relevant MeSH terms: Vocal Cord Dysfunction; Hypocalcemia; Thyroid Diseases; Dexamethasone

Study Results

No Results Posted as of Feb 12, 2021