PDHD and POVN Spinal Anesthesia

This dataset contains clinical trial data from a randomized, controlled trial designed to evaluate the effectiveness of gabapentin, ketamine, their combination, and placebo for preventing postoperative nausea, vomiting, and headache after spinal anesthesia in elective cesarean delivery. The trial included four groups: one receiving only gabapentin, one receiving only ketamine, one receiving a combination of both drugs, and a placebo group. Participants were assessed for the primary outcomes—headache, nausea severity, and vomiting frequency—at four time points: 1, 6, 12, and 24 hours after surgery. Additionally, maternal satisfaction was measured at 24 hours, and neonatal health was evaluated using Apgar scores recorded at 1 and 5 minutes post-delivery.
The data includes both continuous and categorical variables, such as the severity of headache and nausea, which were recorded on 0-10 visual analogue scales (VAS). The dataset also includes baseline demographic and clinical variables, including maternal age, BMI, and obstetric history (e.g., gravidity, ASA classification).
This dataset was collected in a single-center setting, with randomization performed using a 1:1:1:1 allocation scheme to ensure equal distribution of participants across the four groups. A total of [N] participants were enrolled, with complete data for all primary outcomes and minimal missing data (less than 5% across all variables). Participants were assigned to receive either gabapentin (300 mg orally), ketamine (0.25 mg/kg IV bolus), a combination of both drugs, or placebo (matching oral capsules and IV saline).
All participants were healthy, non-obese parturients (classified as ASA II) scheduled for elective cesarean delivery under spinal anesthesia. Exclusion criteria included a history of chronic headache, prior use of antiemetics within 24 hours, or any contraindications to the study drugs. The primary goal of the study was to determine whether gabapentin, ketamine, or their combination could reduce the incidence and severity of nausea, vomiting, and headache compared to placebo. Secondary outcomes included the assessment of neonatal health (via Apgar scores) and maternal satisfaction at 24 hours.
The data collected from this study will be valuable for future meta-analyses of post-cesarean anesthesia-related complications and will provide insight into the role of gabapentin and ketamine in preventing these common post-operative issues. The dataset allows for the comparison of individual drugs versus their combination, making it useful for analyzing potential synergistic effects or dose-sparing properties. Additionally, it provides a complete picture of both maternal and neonatal outcomes, offering valuable data for obstetric anesthesiologists in tailoring post-operative care.