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

Randomized, double-blind, active controlled, parallel group, phase 3 clinical trial conducted on 150 patients. Randomization was performed using Random Allocation Software.

This is a Randomized, Double-Blind Clinical Trial aiming to compare the efficacy of Propofol and Dexamethasone on Post-Dural Puncture Headache (PDPH) following spinal anesthesia. 150 pregnant women scheduled for elective Cesarean section at Kowsar Hospital in Urmia will be randomly divided into two parallel groups (Propofol or Dexamethasone). ​For blinding purposes, medications are prepared in coded syringes by a person not involved in patient management, keeping both the patient and the assessor blinded to the drug type.

Inclusion Criteria: ​Pregnant women aged between 18 and 45 years; ​ASA physical status I or II (American Society of Anesthesiologists classification); Candidates for elective Cesarean section ​Exclusion Criteria: High-risk or induced pregnancy; Presence of uncontrolled chronic diseases (e.g., thyroid diseases, type I and II diabetes, hypertension, and cardiovascular disease); History of chronic headache, such as migraine; History of substance or corticosteroid use; Fever exceeding 38 degrees; Contraindications to spinal anesthesia

Intervention group 1 (Propofol): Receiving Propofol infusion at a dose of 30 micrograms/kilograms/minute via infusion pump, immediately after neonate delivery. Intervention group 2 (Dexamethasone): Receiving 8 milligrams Dexamethasone intravenously, immediately after neonate delivery.

Headache score based on Visual Analog Scale.

Use of Random allocation software

​This study will be conducted as a double-blind randomized clinical trial. This means that the participants (pregnant women undergoing elective Cesarean section) and the study investigator/outcome assessor (who collects the outcome data) will be kept unaware of the type of drug administered to the patient. ​To ensure blinding, the study drugs (Propofol and Dexamethasone) will be prepared by an anesthesiologist who is not involved in the patient's anesthesia or post-operative management. The drugs will be prepared in identical volume coded syringes. These syringes will be coded so that neither the patient nor the investigator collecting the data (e.g., headache score via VAS) will be able to identify which treatment group (Group D or Group P) the patient belongs to. Furthermore, the data analyst may also remain blinded until the final data analysis is complete to prevent bias in result interpretation.

De-identified Individual Participant Data (IPD) including demographic variables, headache intensity scores based on VAS criteria, and hemodynamic parameters (SBP, DBP, MAP, HR, SPO2) along with the study protocol will be available for sharing.

Access to data will be available 6 months after the publication of the final results and will continue for 2 years.

Researchers employed in academic and scientific institutions who intend to conduct meta-analysis or systematic reviews on clinical trial data in the field of anesthesia management and postoperative pain.

Data is usable solely for secondary statistical analysis and inclusion in meta-analysis studies. Use of data is conditional upon citing the original source and adhering to publication ethics.

Dr. Nasim Shamsa (Assistant Professor of Anesthesiology, Urmia University of Medical Sciences). Aiden Kharazi Email: aiden.kharazi@gmail.com

Applicants must send their written request, including the research proposal and analysis objectives, to the corresponding author's email address. Upon scientific and ethical review by the principal investigators, data will be shared as an encrypted file.