Comparitive Evaluation of Propofol and Midazolam as Conscious Sedatives in Minor Oral Surgery.

OBJECTIVE: The objective of the study was to assess the efficacy of propofol and midazolam as an intravenous sedative agent in minor oral surgical procedures in terms of: (a) the onset of action, (b) heart rate, (c) oxygen saturation, (d) systolic and diastolic blood pressure, (e) respiratory rate, (f) pain during the injection of sedative agent, (g) recovery period, (h) side effects, (i) patient's cooperation during the surgery.
METHODOLOGY: This was a double blind randomized study in which one group of 20 patients received propofol with the induction dose of 0.5 mg/kg and 50 μg/kg/min which was administered by syringe infusion pump as a maintenance dose and the other group received midazolam in a single dose of 75 μg/kg and no maintenance dose was given, instead 5 % dextrose was administered by syringe infusion pump at the rate of 50 μg/kg/min. Since propofol was milky white in colour, a green cloth was covered over the infusion pump in all cases. The surgeon, assistants and observers were blind about the medications which would be given to the patient for sedation. After the administration of the sedative, local anesthesia was achieved with 2 % lignocaine hydrochloride.
RESULTS: The onset of action in propofol group was significant as onset of action was faster. The maximum increase in heart rate in propofol group was at 10 min intraoperatively (Mean ± 80.40 ± 12.73) and that in midazolam group was at 15 min intraoperatively (Mean 79.25 ± 13.44). Post operatively the heart rate decreased near to the baseline value in both the groups. The average oxygen saturation before induction in propofol group was 99.7 ± 0.73 % and that of midazolam group was 99.15 ± 01.31 P = 0.314. None of the patients in this study developed apnea. The systolic blood pressure (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives. The diastolic blood pressure (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives and the decreased diastolic blood pressure was maintained throughout the procedure. The respiratory rate (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives. The decreased respiratory rate remained throughout the surgical procedure. Pain during the injection of the sedatives was reported by nine patients (45 %) in the propofol group whereas none of the patients in midazolam group complained of pain during the injection. This is statistically significant (P = 0.001). The recovery time (Mean ± SD) in propofol group was 22.50 ± 3.04 (range 15-25 min) and that in midazolam group was 33.75 ± 3.93 (range 30-40 min), which was statistically significant (P < 0.001). Patients in the propofol group were significantly less co-operative than midazolam group at both 10 and 25 min intra operatively.
CONCLUSION: The design of the present study permitted qualitative assessment of propofol and midazolam as sedative agents in minor oral surgical procedures. The ideal anesthetic agent should provide rapid onset of action, profound intra operative amnesia while ensuring rapid recovery without much complications. There were no significant differences in either patient demographics or surgical characteristics between the two groups. The propofol group was less co-operative than midazolam group. Pain during the injection of sedative was a significant adverse effect in the propofol group. Cardiovascular parameters remained stable throughout the procedure in both study groups and no intervention was required. However recovery and onset of action was faster in the propofol group as compared with the midazolam group.

RCT Entities:   Population Interventions Outcomes