A randomized double-blind study comparing Ketofol and Propofol-fentanyl for procedural sedation in minor gynaecological surgeries

Abstract

Background: Procedural sedation is essential in minor gynaecological surgeries to ensure rapid onset, adequate anaesthetic depth, hemodynamic stability, early recovery, and minimal adverse effects. Common regimens include ketamine combined with propofol (Ketofol) and propofol with fentanyl, but comparative efficacy and safety remain unclear. This study compared ketamine-propofol combinations (1:1 and 1:2) with propofol-fentanyl for procedural sedation in elective minor gynaecological surgeries, focusing on sedation quality, hemodynamic effects, recovery, postoperative pain, and adverse events.Methods: This prospective, randomised, double-blind controlled trial was conducted at the District Headquarters Hospital with the Government Medical College, Khammam, Telangana, India, after Institutional Ethics Committee approval. Sixty ASA I-II women aged 18-50 years undergoing elective minor gynecological procedures were randomly allocated into three groups (N=20 each): ketofol 1:1 (Group I), ketofol 1:2 (Group II), and propofol-fentanyl (Group III). Sedation was titrated intravenously to achieve a Ramsay Sedation Score of 5-6. Sedation characteristics, PRST (Evans) scores, hemodynamic parameters, recovery time using the Modified Aldrete Score, postoperative pain using the Wong-Baker FACES scale, and adverse events were recorded. Data were analyzed using one-way ANOVA and Turkey’s HSD test (p<0.05).Results: Demographic characteristics and surgical duration were comparable among groups. Group II achieved adequate sedation faster than Groups I and III (P=0.02) and showed superior intraoperative sedation with lower PRST values. Propofol-fentanyl was associated with greater reductions in heart rate and mean arterial pressure. Recovery was fastest in Group III, followed by Group II and Group I (p<0.001). Postoperative pain and respiratory and hemodynamic adverse events were higher in Group III, while emergence phenomena were more frequent in Group I.Conclusion: Ketofol in a 1:2 ratio provides faster onset, better intraoperative sedation, improved autonomic stability, and fewer adverse effects, making it a balanced option for sedation in minor gynecological surgeries.