Determining the Effects of Intrathecal Fentanyl on Maternal Hemodynamic Changes and Neonatal Apgar Scores in Elective Cesarean Sections
Design
This study is a phase III randomized, double‑blind, controlled clinical trial with parallel groups conducted on 100 patients. Participants will be allocated to the study groups using block randomization based on computer‑generated random numbers produced by Random Allocation software.
Settings and conduct
This is a randomized double-blind clinical trial conducted at Kosar Hospital in Urmia. Candidates for elective cesarean section are allocated to intrathecal fentanyl and control groups. Spinal anesthesia is performed according to protocol, and maternal hemodynamic changes and neonatal Apgar scores are recorded. Both patients and outcome assessors are blinded, and the medications are prepared by an independent anesthesiologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age of 37–40 weeks, singleton pregnancy, ASA physical status I or II, and provision of informed consent.
Exclusion criteria: Presence of maternal conditions such as preeclampsia, severe cardiovascular, hepatic, or renal diseases; known hypersensitivity to fentanyl or local anesthetics; contraindications to spinal anesthesia (e.g., coagulation disorders or infection at the injection site); emergency delivery or fetal distress; morbid obesity (BMI > 40); and severe hemorrhage.
Intervention groups
Patients in the intervention group (intrathecal fentanyl group) will receive a solution containing 0.5% hyperbaric bupivacaine (10–12 mg) combined with 25 µg of fentanyl (0.5 mL). Patients in the control group will receive only a solution containing 0.5% hyperbaric bupivacaine (10–12 mg).
Main outcome variables
Effect of Intrathecal Fentanyl on Maternal Hemodynamic Changes and Neonatal Apgar Scores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260425069157N3
Registration date:2026-05-11, 1405/02/21
Registration timing:prospective
Last update:2026-05-11, 1405/02/21
Update count:0
Registration date
2026-05-11, 1405/02/21
Registrant information
Name
Roghayea Neisari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
nisari.r@umsu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effects of intrathecal fentanyl on maternal hemodynamic changes and neonatal Apgar in elective cesarean sections
Public title
Evaluation of the Effect of Adding Fentanyl to Cesarean Section Anesthesia on Maternal and Neonatal Outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age of 37 to 40 weeks
Singleton pregnancy
ASA class I or II
Informed consent to participate in the study
Exclusion criteria:
Presence of maternal diseases such as preeclampsia
Severe cardiovascular diseases
Hepatic or renal diseases
Known hypersensitivity to fentanyl or local anesthetic drugs
Presence of contraindications to spinal anesthesia (such as coagulation disorders or infection at the injection site)
Emergency delivery or fetal distress
Morbid obesity (BMI > 40) and cases with severe bleeding
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
One hundred patients who are candidates for elective cesarean section will be randomly allocated into intervention and control groups using block randomization based on computer‑generated numbers created by Random Allocation software. Patients in the intervention group (intrathecal fentanyl group) will receive a solution containing 0.5% hyperbaric bupivacaine (10–12 mg) plus 25 µg fentanyl (0.5 mL). Patients in the control group will receive only a solution containing 0.5% hyperbaric bupivacaine (10–12 mg).
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted in a double‑blind manner; therefore, the medications will be prepared and administered by an anesthesiologist who is not involved in outcome assessment. Consequently, both the patients and the outcome assessor will be blinded to the group allocation (intervention or control).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital
Street address
Imam Khomeini University Hospital., Ershad Ave., Modarres Blvd., Urmia., Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Approval date
2026-01-23, 1404/11/03
Ethics committee reference number
IR.UMSU.HIMAM.REC.1404.113
Health conditions studied
1
Description of health condition studied
Elective Cesarean Section, Spinal Anesthesia in Cesarean Section
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication
Primary outcomes
1
Description
Maternal hemodynamic changes, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR).
Timepoint
Before spinal anesthesia (baseline) and at 1, 3, 5, 10, and 15 minutes after spinal anesthesia.
Method of measurement
Hemodynamic parameters are measured and recorded using standard anesthesia monitoring equipment, including a non‑invasive blood pressure monitor and ECG.
Secondary outcomes
1
Description
Neonatal Apgar score at 1 and 5 minutes after birth
Timepoint
At 1 minute and 5 minutes after birth.
Method of measurement
Apgar score is assessed by the neonatal team based on the five standard components: heart rate, respiratory effort, muscle tone, reflex irritability, and skin color.
Intervention groups
1
Description
Intervention group: Patients in the intervention group (intrathecal fentanyl group) will receive a solution containing 10–12 mg of 0.5% hyperbaric bupivacaine combined with 25 micrograms of fentanyl (0.5 mL).
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group will receive only a solution containing 10–12 mg of 0.5% hyperbaric bupivacaine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Kowsar Hospital
Full name of responsible person
Dr. Roghayea Neisari
Street address
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 0998
Fax
+98 44 3346 5079
Email
nisari.r@umsu.ac.ir
Web page address
https://kosar.umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Urmia University of Medical Sciences., Emergency Alley., Resalat Boulevard., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
sabergholizadeh@yahoo.com
Web page address
http://umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Roghayea Neisari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3346 0998
Fax
+98 44 3346 5079
Email
nisari.r@umsu.ac.ir
Web page address
https://kosar.umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Roghayea Neisari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 0998
Fax
+98 44 3346 5079
Email
nisari.r@umsu.ac.ir
Web page address
https://kosar.umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Roghayea Neisari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kosar Comprehensive Women’s Educational and Medical Center., Hasani Street., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 0998
Fax
+98 44 3346 5079
Email
nisari.r@umsu.ac.ir
Web page address
https://kosar.umsu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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