Protocol summary
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Study aim
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Evaluation of the prophylactic effect of ondansetron during surgery on postoperative delirium in elderly patients undergoing orthopedic surgery
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Design
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A controlled, parallel-group, double-blind, randomized-phase 3 clinical trial on 100 patients. Random numbers of random allocation software were used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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In the intervention group patients received 8 mg of intravenous ondansetron and in the placebo group received 8 mg of intravenous normal saline.
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Main outcome variables
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Delirium
General information
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Reason for update
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Modify the sampling date
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Acronym
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IRCT registration information
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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
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Registration date
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2020-11-16, 1399/08/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-21, 1399/09/01
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Expected recruitment end date
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2021-06-20, 1400/03/30
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Actual recruitment start date
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2020-11-21, 1399/09/01
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Actual recruitment end date
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2021-06-20, 1400/03/30
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Trial completion date
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2021-06-20, 1400/03/30
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Scientific title
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Evaluation of the prophylactic effect of Ondansetron during surgery on postoperative delirium in elderly patients undergoing orthopedic surgery
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Public title
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The effect of Ondansetron on postoperative delirium in elderly patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
100
Actual sample size reached:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomly divided into intervention and placebo groups using Random allocation software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-30, 1397/03/09
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Ethics committee reference number
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IR.UMSU.REC.1397.112
Health conditions studied
1
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Description of health condition studied
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Delirium
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ICD-10 code
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F13.931
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ICD-10 code description
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Sedative, hypnotic or anxiolytic use, unspecified with withdrawal delirium
Primary outcomes
1
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Description
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Delirium
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Timepoint
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Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery
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Method of measurement
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4- point scale
Secondary outcomes
1
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Description
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Nausea
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Timepoint
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Recovery,30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
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Method of measurement
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Clinical examination
2
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Description
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Vomoting
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Timepoint
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Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
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Method of measurement
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Leakage of stomach contents
3
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Description
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Pruritus
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Timepoint
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Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
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Method of measurement
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Clinical examination
4
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Description
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Shivering
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Timepoint
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Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery.
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Method of measurement
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Clinical examination
Intervention groups
1
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Description
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Intervention group: 8 mg of Intravenous ondansetron
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Category
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Treatment - Drugs
2
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Description
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Control group: 8 mg of intravenous normal saline
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Oroumia University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available