Ondansetron and Dexamethasone for Prevention of PDPH, Nausea, and Vomiting
- Conditions
- Postdural Puncture HeadachePostoperative Nausea and VomitingObstetric Anesthesia Problems
- Interventions
- Registration Number
- NCT07068230
- Lead Sponsor
- Minia University
- Brief Summary
This prospective, randomized, double-blind, placebo-controlled study was conducted at the Obstetrics and Gynecology Department of El-Minia University Hospital from October 2018 to October 2019. It enrolled 150 parturients aged 18-45 years undergoing elective cesarean section under spinal anesthesia. Participants were randomly assigned to one of three groups to receive either 8 mg IV ondansetron, 8 mg IV dexamethasone, or 5 mL of IV normal saline 5 minutes before spinal anesthesia. The primary objective was to evaluate the effectiveness of prophylactic ondansetron and dexamethasone in reducing the incidence of postdural puncture headache (PDPH). Secondary outcomes included severity and duration of PDPH, incidence and severity of nausea and vomiting, hemodynamic parameters, and neonatal Apgar scores. Ethical approval was obtained and verbal informed consent was collected from all participants.
- Detailed Description
This study is a single-center, prospective, randomized, double-blind, placebo-controlled clinical trial conducted to evaluate the efficacy of prophylactic intravenous administration of ondansetron and dexamethasone in reducing the incidence and severity of postdural puncture headache (PDPH), and postoperative nausea and vomiting (PONV), in parturients undergoing elective cesarean section under spinal anesthesia.
A total of 150 parturients (ASA I or II), scheduled for cesarean delivery at Minia University Hospital, were randomly allocated into three parallel groups (1:1:1 ratio) using computer-generated randomization with sealed opaque envelopes to conceal allocation.
All patients received standard spinal anesthesia with 0.5% hyperbaric bupivacaine via a 25-gauge Quincke spinal needle in the sitting position at the L3-L4 or L4-L5 interspace. Prior to spinal anesthesia, patients in:
Group A (Ondansetron group) received 8 mg ondansetron IV (diluted to 5 mL in saline),
Group B (Dexamethasone group) received 8 mg dexamethasone IV (diluted to 5 mL),
Group C (Control group) received 5 mL of 0.9% normal saline IV.
Study drugs were administered 5 minutes prior to the intrathecal injection. Blinding was maintained for patients, anesthesiologists, and outcome assessors.
PDPH was assessed for 7 days postoperatively. A standardized questionnaire and the Corbey scale were used to evaluate headache onset, severity, duration, and need for analgesics. Nausea and vomiting were assessed intraoperatively and postoperatively (up to 48 hours). Standard antiemetic rescue therapy was available as needed.
The protocol adhered to CONSORT guidelines and was approved by the Minia University Faculty of Medicine Research Ethics Committee. All participants provided written informed consent prior to enrollment.
This trial investigates whether prophylactic ondansetron or dexamethasone, individually, can significantly reduce PDPH and PONV compared to placebo. The results are expected to inform perioperative management and enhance maternal outcomes in cesarean section under spinal anesthesia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ondansetron Group Ondansetron 8mg Participants in this group received 8 mg of intravenous ondansetron diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia. Dexamethasone Group Dexamethasone Participants in this group received 8 mg of intravenous dexamethasone diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia. Placebo Group Saline Participants in this group received 5 mL of intravenous normal saline as placebo, administered 5 minutes before spinal anesthesia.
- Primary Outcome Measures
Name Time Method Incidence of Postdural Puncture Headache (PDPH) Up to 14 days postoperatively The primary outcome is the proportion of participants in each group who develop postdural puncture headache within 14 days following spinal anesthesia for elective cesarean section. Diagnosis is based on clinical criteria assessed during follow-up calls on postoperative days 7 and 14 by a blinded anesthesiologist.
- Secondary Outcome Measures
Name Time Method Severity of PDPH Up to 14 days postoperatively Severity of PDPH will be assessed using the Corbey Headache Severity Scale, which categorizes headache as:
Mild (no limitation of daily activity),
Moderate (some limitation of activity but no bed rest required), and
Severe (requires bed rest). Scale: Mild to Severe - higher levels indicate worse outcomeDuration of PDPH Up to 14 days postoperatively Duration (in days) from onset to resolution of PDPH symptoms in affected participants.
Incidence of Nausea and Vomiting (N/V) Intraoperatively and up to 4 days postoperatively Incidence of intraoperative and postoperative nausea and vomiting, assessed using a 4-point scale (0 = none, 1 = nausea only, 2 = nausea and vomiting, 3 = repeated vomiting).
Neonatal Outcome (Apgar Score at 1 and 5 minutes) At 1 minute and 5 minutes after birth Neonatal wellbeing will be assessed using the Apgar Score, a standardized clinical scale that evaluates Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration.
Scale Description:
Minimum Score: 0 (worst outcome)
Maximum Score: 10 (best outcome)
Higher scores reflect better neonatal condition
Related Research Topics
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Trial Locations
- Locations (1)
El-Minia University Hospital
🇪🇬Minya, Egypt
El-Minia University Hospital🇪🇬Minya, Egypt