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The effect of Ondansetron on postoperative delirium in elderly patients

Evaluation of the prophylactic effect of Ondansetron during surgery on postoperative delirium in elderly patients undergoing orthopedic surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170515033986N1
Enrollment
100
Registered
2020-11-16
Start date
2020-11-21
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium. Sedative, hypnotic or anxiolytic use, unspecified with withdrawal delirium

Interventions

Intervention 1: Intervention group: 8 mg of Intravenous ondansetron. Intervention 2: Control group: 8 mg of intravenous normal saline.

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Delirium. Timepoint: Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery. Method of measurement: 4- point scale.

Secondary

MeasureTime frame
Nausea. Timepoint: Recovery,30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery. Method of measurement: Clinical examination.;Vomoting. Timepoint: Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery. Method of measurement: Leakage of stomach contents.;Pruritus. Timepoint: Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery. Method of measurement: Clinical examination.;Shivering. Timepoint: Recovery, 30 minutes, one hour, 6 hours, 8 hours and 24 hours after surgery. Method of measurement: Clinical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Nazli Karami

Oroumia University of Medical Sciences

karami.n@umsu.ac.ir+98 44 3198 8293

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026