Title : Comparison of the effect of ketofol and ketodex as procedural sedation and analgesia for Oocyte retrieval during in-vitro fertilisation procedures - A randomized controlled pilot study
Abstract:
Introduction: Infertility affects 10-15% of couples, prompting assisted reproductive techniques IVF. Oocyte retrieval in IVF induces pain, correlating with follicle aspiration duration. Current anesthetic agents, including midazolam, propofol, and fentanyl, pose drawbacks and impact oocyte quality. These anesthetic agents, in addition, are found in the follicular fluid, which has detrimental effects on oocyte fertilization and embryonic development. Propofol's presence in follicular fluid affects fertilization negatively. The study hypothesizes that KETODEX (ketamine with dexmedetomidine) provides superior pain relief during IVF compared to KETOFOL (ketamine with propofol) with minimal effects on fertility and cleavage.
Aims and objectives: The primary objective is to compare cumulative pain scores between KETODEX and KETOFOL intra-operatively and within 2 hours post-retrieval, assessing impacts on oocyte quality, fertility, cleavage, and pregnancy rate. Additionally, the study aims to provide opioid-free analgesia during IVF oocyte retrieval.
Materials and methods: This Open-Label Single-Center Randomized Controlled Trial at AIIMS, New Delhi, involves patients aged 20-40, ASA grade I-II, scheduled for oocyte retrieval. Randomization via computer-generated numbers assigns patients to either the KETOFOL [KP] (Ketamine with propofol) or KETODEX [KD] (Ketamine with dexmedetomidine) group of sample size 30 each. Exclusion criteria include BMI >35, ASA grade III-IV, refusal of consent, allergies to study drugs, autonomic dysfunction, uncontrolled systemic illnesses, and chronic diseases. Pre-anesthetic check-ups and informed consent precede surgery, with specific fasting protocols. Intraoperatively, groups receive designated drug combinations, with doses adjusted based on sedation scores, and BIS levels. The study aims to evaluate anesthetic efficacy, pain, and patient outcomes.
Results: This abstract summarizes statistical analyses in the thesis, employing the Kolmogorov-Smirnov test for data normality. Nonparametric tests, including the Mann-Whitney Test and Independent t-test, assessed variables. In the KP group, propofol doses in milligrams (mean±SD: 242±52, median: 250) and rescue boluses (mean±SD: 97.33±30.5, median: 95) surpassed the KD group. Ketamine dose in milligrams (mean±SD: 32.33±7.74, median: 30) and surgery duration in minutes (mean±SD: 24.17±7.44, median: 20) showed no significant differences. Lower fertility rates were observed in KP (p<0.0007), with comparable cleavage rates on days 2 and 3 but higher in KD. Intraoperative rescue analgesic need (60%) and complications (53.33%, p<0.0001) were higher in KP. KP exhibited a shorter time to awakening (mean 3.8±1.37, median 4 [3-4.75], p<0.195). Although postoperative pain scores showed no significant difference, mild pain (VAS) occurred in KP at 10 and 30 minutes, contrasting with KD's pain-free status until 2 hours postoperatively.
Conclusion: In the KD group, comprising ketamine and dexmedetomidine, stable hemodynamics were maintained during IVF procedures, and no respiratory distress or apnea occurred. Oocyte grades showed no significant differences, with no impact on embryo quality and fertility rate. However, KD exhibited higher cleavage rates at day 2 and day 3 compared to the KP (ketamine with propofol) group, suggesting improved pregnancy outcomes. The KD group experienced minimal pain intraoperatively and up to 2 hours postoperatively, contrasting with the 60% of patients in the KP group requiring fentanyl and reporting mild pain. KD demonstrated fewer complications (PONV) both intra and post-operatively. Notably, both surgeons and patients expressed higher satisfaction in the KETODEX group.
