Assessment of the thiamine effect on post-operative delirium occurrence in patients undergoing hip surgery in intensive care unit

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057489N1

Enrollment

Registered

2023-02-28

Start date

2022-09-22

Completion date

Unknown

Last updated

2023-03-13

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

Conditions

delirium. Delirium due to known physiological condition

Interventions

Intervention 1: Intervention group: Intervention of a 300 mg oral thiamine tablet daily for 3 days. Intervention 2: Control group: One 300 mg placebo tablet for 3 days.

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 60 years old after hip surgery Hospitalization in the intensive care unit

Exclusion criteria

Exclusion criteria: Patients with a history of mental disorder Severe renal failure Severe liver failure Drug or alcohol abuse Diabetic ketoacidosis History of delirium

Design outcomes

Primary

Measure	Time frame
The effects of thiamine to prevent delirium. Timepoint: 76 / 5,000Translation resultsTranslation resultHip surgery patients over the age of 60 were hospitalized in the intensive care unit for 3 days. Method of measurement: First, changes in the level of consciousness in the intensive care unit will be evaluated based on the Richmond restlessness-calmness scale. The degree of restlessness will be divided from 0 to 4. In unconscious patients, the level of sedation will be scored based on the duration of eye contact (-1 to -3). Patients without opening their eyes following verbal stimulation (recorded as -4 to -5) will not be included in the study (45). CAM-ICU includes four characteristics: (1) change in mental status from the beginning, (2) inattention, (3) disturbed thinking, and (4) change in level of consciousness. If the patient is positive for both features 1 and 2 and any feature 3 or 4, delirium will be diagnosed. During the study period, sedation and delirium will be evaluated for each patient every 12 hours. Fentanyl narcotic will be used for patients for post-operative analgesia. If any of the patients develop delirium, haloperidol 5 mg intramuscularly will be used. Any new episode, flushing, itching, diaphoresis, nausea, and phonic edema during the study period will be considered as side effects of thiamine drugs.	—

Measure

Time frame

The effects of thiamine to prevent delirium. Timepoint: 76 / 5,000Translation resultsTranslation resultHip surgery patients over the age of 60 were hospitalized in the intensive care unit for 3 days. Method of measurement: First, changes in the level of consciousness in the intensive care unit will be evaluated based on the Richmond restlessness-calmness scale. The degree of restlessness will be divided from 0 to 4. In unconscious patients, the level of sedation will be scored based on the duration of eye contact (-1 to -3). Patients without opening their eyes following verbal stimulation (recorded as -4 to -5) will not be included in the study (45). CAM-ICU includes four characteristics: (1) change in mental status from the beginning, (2) inattention, (3) disturbed thinking, and (4) change in level of consciousness. If the patient is positive for both features 1 and 2 and any feature 3 or 4, delirium will be diagnosed. During the study period, sedation and delirium will be evaluated for each patient every 12 hours. Fentanyl narcotic will be used for patients for post-operative analgesia. If any of the patients develop delirium, haloperidol 5 mg intramuscularly will be used. Any new episode, flushing, itching, diaphoresis, nausea, and phonic edema during the study period will be considered as side effects of thiamine drugs.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Amin Valizad Hasanlui

Oroumia University of Medical Sciences

aminvalizade@yahoo.com+98 44 3346 9931

Outcome results

None listed

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