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Post total thyroidectomy hypocalcemia in toxic MNG and effect of post operative intravenous calcium gluconate in its incidence

Protocol summary

Study aim
To see the effectiveness of prophylactic infusion of intravenous calcium gluconate in incidence of post operative hypocalcemia after total thyroidectomy.
Design
Two arm parallel group, single blinded, randomized control trial with post operative intervention and outcome
Settings and conduct
The study was single blinded in which participants were blinded. They were not told in which group they fall. The study will conducted in Combined Military Hospital, Bahawalpur, Pakistan
Participants/Inclusion and exclusion criteria
Patient undergoing total thyroidectomy, having toxic multinodular goiter, having normal pre operative calcium level, having no parathyroid disorder, having no recurrent thyroid disease or willing for part of study were included in study. Patient who were not with toxic multinodular goiter, who were going lobectomy or isthmusectomy only, who were having parathyroid disease, having allergy to calcium gluconate, having deranged pre operative calcium level, taking preoperative calcium supplements, not willing for part of study or whose data could not be maintained were excluded from study.
Intervention groups
In intervention group, preoperative calcium level will be measured and after surgery 1 g of intravenous infusion of calcium gluconate was given (60 minutes infusion) then post op calcium was checked after 12 hours. In control group preoperative calcium level will be measured and after surgery 10 ml normal saline in 100 ml of infusion was given over 60 minutes and post of calcium was checked after 12 hours.
Main outcome variables
Post Operative Calcium level, post operative hypocalcemia duration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240503061640N1
Registration date: 2024-05-20, 1403/02/31
Registration timing: retrospective

Last update: 2024-05-20, 1403/02/31
Update count: 0
Registration date
2024-05-20, 1403/02/31
Registrant information
Name
Muhammad Ahsan Mustafa
Name of organization / entity
CPSP
Country
Pakistan
Phone
+92 333 3396180
Email address
whereisdrahsan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-15, 1402/07/23
Expected recruitment end date
2024-05-15, 1403/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Post total thyroidectomy hypocalcemia in toxic MNG and effect of post operative intravenous calcium gluconate in its incidence
Public title
Post total thyroidectomy hypocalcemia in toxic MNG and effect of post operative intravenous calcium gluconate in its incidence
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who are with toxic multinodular goiter. Patient who underwent total thyroidectomy. Patient whose pre op calcium level were normal. Pateint who did not have any parathyroid disease. Patient who give consent for study research.
Exclusion criteria:
Patient who are not with toxic multinodular goiter. Patient who have solitary thyroid nodule, hypothyroid, diffuse goiter, thyroid carcinoma and recurrent thyroid swelling. Patient who didn't give consent for study research. Pateint who were not followed. Patient whose pre op calcium were not normal. Patient who were taking pre op calcium supplements. Patient who have parathyroid disease. Pateint who underwent lobectomy and isthmusectomy Patient having any allegy to calcium gluconate.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 65
Randomization (investigator's opinion)
Randomized
Randomization description
I used computer generated software SPSS version 23 for randomization. First the sample size was randomized into two groups by using SPSS. Then subjects were assign to each group accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were told that they will given post op intravenous calcium gluconate 1 gram 10 ml in 100 ml of infusion as a single dose, or given 10 ml of IV normal saline in 100 ml infusion as a placebo. After informed written consent Patient will be given either medicine post operative. Patient will be told that they will not know which medicine is given to them. As color of both medicine are same, so Patient will not be know which medicine is given. Medicine will be given by resident surgery.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee CMH Bahawalpur
Street address
CMH Bahawalpur cantt
City
Bahawalpur
Postal code
63100
Approval date
2023-09-01, 1402/06/10
Ethics committee reference number
1516-EC-01-2023

Health conditions studied

1

Description of health condition studied
Toxic Multinodular goiter and Hypocalcemia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Post total thyroidectomy hypocalcemia
Timepoint
Before and After 12 hours, 24 hours and 48 hour of intervention
Method of measurement
Use laboratory calcium testing machine for measuring calcium level

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group participants pre operative calcium level will be checked by laboratory calcium testing machine. Then total thyroidectomy will be done for toxic MNG. After surgery patient will be given post operative calcium supplements as single dose intravenous calcium gluconate 1g in 100 ml infusion (in 6 hours). Then post operative calcium levels will be checked after 12, 24 and 48 hours.
Category
Treatment - Drugs

2

Description
Control group: In this group participants pre operative calcium level will be checked by laboratory calcium testing machine. Then total thyroidectomy will be done for toxic MNG. After surgery patient will be given post operative normal saline 10 ml as single dose in 100 ml infusion (in 6 hours). Then post operative calcium levels will be checked after 12, 24 and 48 hours.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Combined Military Hospital
Full name of responsible person
Dr Muhammad Ahsan Mustafa
Street address
CMH Bahawalpur cantt
City
Bahawalpur
Postal code
63100
Phone
+92 333 3396180
Email
whereisdrahsan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Combined Military Hospital
Full name of responsible person
Muhammad Ahsan Mustafa
Street address
Bahawalpur cantt
City
Bahawalpur
Postal code
63100
Phone
+92 333 3396180
Email
whereisdrahsan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Combined Military Hospital Bahawalpur
Full name of responsible person
Dr Muhammad Ahsan Mustafa
Position
Trainee
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
Bahawalpur cantt
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 333 3396180
Email
whereisdrahsan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Combined Military Hospital Bahawalpur
Full name of responsible person
Dr Muhammad Ahsan Mustafa
Position
Trainee
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
Bahawalpur cantt
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 333 3396180
Email
whereisdrahsan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Combined Military Hospital Bahawalpur
Full name of responsible person
Dr. Muhammad Ahsan Mustafa
Position
Trainee
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
Bahawalpur cantt
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 333 3396180
Email
whereisdrahsan@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
POST TOTAL THYROIDECTOMY HYPOCALCEMIA IN TOXIC MNG AND EFFECT OF POST OPERATIVE INTRAVENOUS CALCIUM GLUCONATE IN ITS INCIDENCE
When the data will become available and for how long
In January 2025
To whom data/document is available
Only available for people working in academic institute
Under which criteria data/document could be used
whereisdrahsan@yahoo.com
From where data/document is obtainable
whereisdrahsan@yahoo.com
What processes are involved for a request to access data/document
Through email ID
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