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Comparison of hypobaric unilateral spinal anesthesia versus general anesthesia on heart rate, blood pressure change and mortality in hip fracture surgery

Protocol summary

Study aim
To determine the comparative effect of unilateral spinal anesthesia versus general anesthesia on hemodynamics and mortality in hip fracture surgery in the elderly.
Design
Controlled clinical trial, with parallel groups, phase 3 on 60 patients.
Settings and conduct
This study will be conducted as a clinical trial on patients over 60 years of age with hip fracture referred to Shahid Rajaee Hospital in Qazvin. In the intervention group, patients will undergo unilateral spinal anesthesia with hypobaric solution injection including ropivacaine and sufentanil in the subarachnoid space. In the control group, patients will undergo general anesthesia with standard drugs including propofol, midazolam, sufentanil, atracurium, and isoflurane. In both groups, mean arterial blood pressure (MAP) and heart rate will be recorded every three minutes before, during, and after the operation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People over 60 years of age referring to Shahid Rajaee Hospital in Qazvin who are undergoing orthopedic surgery due to a hip fracture. Exclusion criteria: multiple trauma (multiple injuries or damage to other organs), increased intracranial pressure (high ICP), emergency surgery or urgent need for anesthesia, spinal injection site infection, coagulation disorders or high INR, history of stroke (CVA) or myocardial infarction (MI) within the last three months, patients in shock.
Intervention groups
Intervention group: Anesthesia is performed by intra-subarachnoid injection of hypobaric solution containing ropivacaine and sufentanil. Control group: Patients are placed under general anesthesia with standard drugs including propofol, midazolam, sufentanil, atracurium and isoflurane.
Main outcome variables
Incidence of severe intraoperative hypotension, intraoperative norepinephrine and ephedrine intake, seven-day postoperative mortality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250809066791N1
Registration date: 2025-11-04, 1404/08/13
Registration timing: prospective

Last update: 2025-11-04, 1404/08/13
Update count: 0
Registration date
2025-11-04, 1404/08/13
Registrant information
Name
Tarokh Rajabinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
tarokhrajabinezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-04-21, 1405/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hypobaric unilateral spinal anesthesia versus general anesthesia on heart rate, blood pressure change and mortality in hip fracture surgery
Public title
Comparison of hypobaric unilateral spinal anesthesia versus general anesthesia on heart rate, blood pressure change and mortality in hip fracture surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 60 years of age who visit Shahid Rajaee Hospital in Qazvin and undergo orthopedic surgery due to a hip fracture
Exclusion criteria:
Allergy to ropivacaine Multiple trauma
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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 Qazvin University of Medical Sciences
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2025-11-02, 1404/08/11
Ethics committee reference number
IR.QUMS.REC.1404.276

Health conditions studied

1

Description of health condition studied
Hip fracture surgery
ICD-10 code
S72.0
ICD-10 code description
Fracture of head and neck of femur

Primary outcomes

1

Description
Severe hypotension during surgery
Timepoint
From the start of anesthesia to the end of the surgery
Method of measurement
Non-invasive blood pressure measurement with standard monitoring every three minutes

2

Description
Intraoperative norepinephrine intake
Timepoint
From the start of anesthesia or numbing to the end of the surgery
Method of measurement
Total dose recorded on the anesthesia sheet

3

Description
Amount of ephedrine taken during surgery
Timepoint
From the start of anesthesia or numbing to the end of the surgery
Method of measurement
Total dose recorded on the anesthesia sheet

4

Description
Seven-day postoperative mortality
Timepoint
From the end of surgery to seven days later
Method of measurement
Clinical follow-up and hospital record review

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Unilateral Spinal Anesthesia with Ropivacaine and Sufentanil: In this group, patients undergo Unilateral Spinal Anesthesia (ULSA). After injecting 500 cc of normal saline, the patient is placed in a sitting position. The hypobaric anesthetic solution is prepared with the following ingredients: 0.5% Ropivacaine, 2 ml (10 mg) of Sufentanil, 1 ml (5 μg) of distilled water, 1 ml. A total of 4 cc of the prepared solution is injected into the subarachnoid space L4–L5 (or a higher or lower space) with a 23 G needle. After injection, the patient is placed in a lateral position on the non-involved side (fracture area upwards) for 5 minutes to limit the spread of the drug to that side. In case of mild pain during the procedure (NRS <4), an opioid infusion is used. If the patient's pain is not controlled, general anesthesia is performed and the patient is excluded from the study. Monitoring of mean arterial blood pressure (MAP) and heart rate is performed every 3 minutes, as in the control group, and in case of hypotension, treatment with ephedrine and, if necessary, norepinephrine is performed.
Category
Treatment - Drugs

2

Description
Control group: General anesthesia with isoflurane and standard induction drugs: In this group, patients are put under general anesthesia. After injecting 500 cc of normal saline and premedication with midazolam at a dose of 0.02 mg/kg, sufentanil at a dose of 0.2 μg/kg, propofol at a dose of 1 mg/kg, and atracurium at a dose of 0.5 mg/kg, anesthesia is used to induce anesthesia. After ensuring proper airway conditions and performing endotracheal intubation, the patient's anesthesia is maintained with isoflurane and oxygen/medical air based on the patient's hemodynamic status. During the procedure, mean arterial blood pressure (MAP) and heart rate are monitored every 3 minutes. In case of hypotension, a bolus of ephedrine 5 to 10 mg is first injected and repeated if necessary up to a maximum of 20 mg. If hypotension persists, norepinephrine infusion is initiated at a dose of 5–10 μg/min. At the end of the procedure, the patient is monitored and data are recorded for hemodynamic parameters during recovery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei hospital
Full name of responsible person
Tarokh Rajabinezhad
Street address
Shahid Safdari Ave., Padegan Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Email
hosrajaee@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Qazvin University of Medical Sciences
Full name of responsible person
Tarokh Rajabinezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
Tarokhrajabinezhad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Tarokh Rajabinezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
tarokhrajabinezhad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Tarokh Rajabinezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
tarokhrajabinezhad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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