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Protocol summary
Double-blind clinical trial.
A controlled, parallel-group, double-blind, randomized-phase 3 clinical trial on 100 patients. Random numbers of random allocation software were used for randomization.
DoubleA controlled, parallel-group, double-blind, randomized-phase 3 clinical trial on 100 patients. Random numbers of random allocation software were used for randomization.
کار آزمایی بالینی دوسویه کور.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 100 بیمار. برای تصادفی سازی از اعداد تصادفی نرم افزار random allocation استفاده شد.
کار آزماییکارآزمایی بالینی دوسویهدارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز 3 بر روی 100 بیمار. برای تصادفی سازی از اعداد تصادفی نرم افزار random allocation استفاده شد.
General information
2018-06-22, 1397/04/01
2020-11-21, 1399/09/01
20182020-0611-2221 00:00:00
2018-12-21, 1397/09/30
2021-06-20, 1400/03/30
20182021-1206-2120 00:00:00
2018-12-21, 1397/09/30
2021-06-20, 1400/03/30
20182021-1206-2120 00:00:00
بیمار و محقق اصلی و ارزیابی کننده پیامد از اینکه بیمار به گروه مداخاه یا دارونما تعلق داشت بی اطلاع بودند. سرنگ های حاوی دارو و دارونما توسط یک تکنسین بیهوشی که از محتوای مطالعه اطلاعی نداشت آماده و کد بندی شدند.
بیمار و محقق اصلی و ارزیابی کننده پیامد از اینکه بیمار به گروه مداخله یا دارونما تعلق داشت بی اطلاع بودند. سرنگ های حاوی دارو و دارونما توسط یک تکنسین بیهوشی که از محتوای مطالعه اطلاعی نداشت آماده و کد بندی شدند.
بیمار و محقق اصلی و ارزیابی کننده پیامد از اینکه بیمار به گروه مداخاهمداخله یا دارونما تعلق داشت بی اطلاع بودند. سرنگ های حاوی دارو و دارونما توسط یک تکنسین بیهوشی که از محتوای مطالعه اطلاعی نداشت آماده و کد بندی شدند.
Secondary outcomes
#1
recovery,30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
Recovery,30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
recovery,30Recovery,30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
#2
recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
recoveryRecovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
leakage of stomach contents
Leakage of stomach contents
leakageLeakage of stomach contents
#3
itching
Pruritus
itchingPruritus
recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
recoveryRecovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
clinical examination
Clinical examination
clinicalClinical examination
#4
Chilling
Shivering
ChillingShivering
recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
recoveryRecovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
clinical examination
Clinical examination
clinicalClinical examination
Sharing plan
yes
no
yesno
undecided
no
undecidedno
yes
no
yesno
yes
no
yesno
empty
There is no further information
There is no further information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Reporting the results will be as an article.
empty
Reporting the results will be as an article.
گزارش نتایج بصورت چاپ مقاله خواهد بود
empty
گزارش نتایج بصورت چاپ مقاله خواهد بود
after publishing article
empty
after publishing article
بعد از چاپ مقاله
empty
بعد از چاپ مقاله
researchers
empty
researchers
محققین
empty
محققین
as published article
empty
as published article
بصورت مقاله
empty
بصورت مقاله
corresponding author
empty
corresponding author
نویسنده مسئول
empty
نویسنده مسئول
by email address
empty
by email address
از طریق ایمیل
empty
از طریق ایمیل
Protocol summary
Study aim
Evaluation of the prophylactic effect of ondansetron during surgery on postoperative delirium in elderly patients undergoing orthopedic surgery
Design
A controlled, parallel-group, double-blind, randomized-phase 3 clinical trial on 100 patients. Random numbers of random allocation software were used for randomization.
Settings and conduct
In this double-blind study, elderly patients who were candidates for hip and proximal femoral fractures surgery were enrolled in the study in Urmia Imam Khomeini Hospital. Both of the patients and the researcher were blind to the belonging of the patients to the intervention or placebo group.
Participants/Inclusion and exclusion criteria
In this study, the patients over 60 years who were candidates for hip and proximal femoral fracture surgery were enrolled in the study. The patients with a history of dementia, Alzheimer, Parkinson or other neurological disorders, alcohol intake, a history of hearing and speech disorders, a history of receiving anti-depression and sedative drugs, and the patients undergoing the surgery for more than 3 hours were excluded.
Intervention groups
In the intervention group patients received 8 mg of intravenous ondansetron and in the placebo group received 8 mg of intravenous normal saline.
Main outcome variables
Delirium
General information
Reason for update
Modify the sampling date
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033986N1
Registration date:2020-11-16, 1399/08/26
Registration timing:prospective
Last update:2024-06-29, 1403/04/09
Update count:2
Registration date
2020-11-16, 1399/08/26
Registrant information
Name
Nazli Karami
Name of organization / entity
Urmia University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9932
Email address
karami.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
2020-11-21, 1399/09/01
Actual recruitment end date
2021-06-20, 1400/03/30
Trial completion date
2021-06-20, 1400/03/30
Scientific title
Evaluation of the prophylactic effect of Ondansetron during surgery on postoperative delirium in elderly patients undergoing orthopedic surgery
Public title
The effect of Ondansetron on postoperative delirium in elderly patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age over 60 years
Patients with ASA I and ASA II
Patients candidate of hip and proximal femoral fracture surgery
Exclusion criteria:
Patients with a history of dementia, Alzheimer, Parkinson or other neurological disorders
Alcohol usage
Patients with a history of hearing and speech disorders
Patients with a history of receiving of anti-depression and sedatives drugs
Duration of surgery more than 3 hours
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into intervention and placebo groups using Random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, the researcher, and the person who assessed the outcomes were blind to the belonging of the patient to the intervention or placebo group. The syringes containing the drug and placebo were prepared and coded by an anesthesiologist who did not know the content of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences