Evaluation of the prophylactic effect of ondansetron during surgery on postoperative delirium in elderly patients undergoing orthopedic surgery
Design
Double-blind clinical trial.
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
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033986N1
Registration date:2020-11-16, 1399/08/26
Registration timing:retrospective
Last update:2020-11-16, 1399/08/26
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
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2018-12-21, 1397/09/30
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.