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comparison of sedative dosage of Propofol and Dexamethasone on post-dural puncture headache in women undergoing elective caesarean section

comparison of sedative dosage of Propofol and Dexamethasone on post-dural puncture headache after spinal anesthesia in women candidates for elective caesarean section

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251010067579N1
Enrollment
150
Registered
2025-12-09
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

post-dural puncture headache after spinal anesthesia. Spinal and epidural anesthesia-induced headache during the puerperium

Interventions

Intervention 1: Intervention group: Propofol. Intervention 2: Intervention group: Dexamethasone.

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists Physical status Classification I or II (ASA I or II status). Candidates for elective cesarean section surgery. Pregnant women between 18 to 45 years of age. Provision of written informed consent to participate in the study. Absence of absolute contraindication to spinal anesthesia.

Exclusion criteria

Exclusion criteria: High-risk or induced pregnancy Obesity (Body Mass Index or BMI greater than 38kg/m2) Presence of Thyroid disorders Presence of Type I or II Diabetes mellitus History of drug abuse or corticosteroid use Presence of Chronic or uncontrolled medical conditions Hypertension and Cardiovascular disease Fever exceeding 38 degrees Celsius History of Chronis headaches (e.g., Migraine) Absolute contraindication of spinal anesthesia Need for any change in anesthesia technique Occurrence of hemorrhage requiring blood transfusion Allergy to the study medications (Propofol or Dexamethasone)

Design outcomes

Primary

MeasureTime frame
Headache score. Timepoint: 1, 2, 24 hours and 2nd to 7th days after surgery. Method of measurement: Visual analog scale.

Secondary

MeasureTime frame
Systolic Blood Pressure. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Millimeter of mercury (sphygmomanometer).;Diastolic Blood Pressure. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Millimeter of mercury (sphygmomanometer).;Mean Arterial Pressure. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Millimeter of mercury (calculated via specific formula).;Heart rate. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Beats per minute (Pulse oximetry).;Peripheral Oxygen Saturation. Timepoint: 1, 2, 24 hours after surgery. Method of measurement: Percentage (Pulse oximetry).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAiden Kharazi

Oroumia University of Medical Sciences

aiden.kharazi@gmail.com+98 41 3329 1466

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026