Comparison of the frequency of delirium after abdominal surgery in patients receiving general anesthesia and spinal anesthesia
Design
A two-group, parallel-group, non-blinded, non-randomized, phase 3 clinical trial on 66 patients
Settings and conduct
This study will be conducted in Bu Ali Hospital, Tehran in 2025. We will divide patients into two groups: A (general anesthesia) and B (spinal anesthesia). After entering the operating room, patients will be placed under general anesthesia or spinal anesthesia. After surgery and during the postoperative hospitalization, patients will be monitored for delirium. Demographic data will also be extracted from the patients’ records.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age 15-65 years
Signed personal consent form to enter the study
Elective surgery
Exclusion criteria
Operation duration more than 4 hours
Unusual bleeding during surgery
Intervention groups
Patients are placed in two groups: A (general anesthesia) and B (spinal anesthesia).
Main outcome variables
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250113064376N1
Registration date:2025-02-18, 1403/11/30
Registration timing:prospective
Last update:2025-02-18, 1403/11/30
Update count:0
Registration date
2025-02-18, 1403/11/30
Registrant information
Name
Arezoo Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7670 2535
Email address
wiish1999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-20, 1403/12/30
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the frequency of delirium after abdominal surgery in patients receiving general anesthesia and spinal anesthesia.
Public title
Comparison of the frequency of delirium after abdominal surgery in patients receiving general anesthesia and spinal anesthesia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15-65 years
Signing the personal consent form to enter the study
Electiveness of the surgery
Exclusion criteria:
Unusual bleeding during surgery
Operation duration more than 4 hours
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2024-07-02, 1403/04/12
Ethics committee reference number
IR.IAU.TMU.REC.1403.168
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05.8
ICD-10 code description
Other delirium
Primary outcomes
1
Description
Delirium
Timepoint
Postoperatively up to 24 hours after surgery
Method of measurement
View
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: General anesthesia
Category
Treatment - Drugs
2
Description
Intervention group: Spinal anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Arezo Gholami
Street address
at the beginning of Damavand St, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
Wiish1999@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Wiish1999@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezo Gholami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Wiish1999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezo Gholami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Wiish1999@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezo Gholami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Wiish1999@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD