GP4d - Comparison of the Addition of Propofol or Ketamine to a Midazolam and Fentanyl Mixture in IV Sedation for Wisdom Tooth Extraction: A Randomized Controlled Trial

Abstract:

Background: Intravenous sedation techniques are widely used in ambulatory surgery, including dental procedures such as wisdom tooth extraction. Most techniques involve a combination of medications that achieve sedation levels ranging from conscious sedation to deep sedation. Propofol and ketamine are commonly used for deep sedation.1 Previous studies have looked at the combination of propofol and ketamine and reported that this combination prolongs recovery when compared to propofol-remifentanil.2 No studies to date have looked at these medications in isolation. The purpose of this study was to determine if there is a difference in recovery time and post-operative amnesia among patients receiving the addition of propofol to a combination of midazolam and fentanyl mixture during IV sedation for wisdom tooth extraction when compared to ketamine.

Materials and

Methods: The study employed a randomized double blinded within-subject design, where participants were recruited from the dental clinics of Jacobi Medical Center and North Central Bronx Hospital (IRB 2014-3556). Participants were recruited from February 2017 to August 2022. Two separate wisdom tooth extraction procedures were performed on each patient with a minimum of two weeks between each procedure. Prior to the administration of ketamine or propofol, all patients received midazolam, fentanyl, and nitrous oxide, with the dosage protocol specified in Table 1. Medication order was randomized using random computer-generated tables. The recovery tests were conducted twice; once preoperatively and one post-operatively. Amnesia was studied by introducing either a visual and tactile stimulus 20 minutes after induction and after completion of the recovery tests.

The Inclusion criteria required patients to be at least 18 years old and classified as either ASA class 1 or 2. Exclusion criteria included patients with a history of allergy to propofol or ketamine, or a known sensitivity to the study drugs. Additionally, once enrolled, patients who required additional induction agents beyond the protocol described or who would have been excessively sedated by the addition of propofol, or ketamine were excluded. Before enrollment, participants were informed of the study's purpose and procedures, and written informed consent was obtained.

Outcome Measures: Recovery was measured using two psychometric tests (number recognition and Trieger test) that have been validated and shown to be free of learning.3 Amnesia was studied by introducing either a visual and tactile stimulus by interrupting the procedure momentarily. Participants were first asked post operatively to recall the stimuli, and if unable to then identify the stimuli. Descriptive statistics and a paired sample t test was conducted for all variables using SPSS.

Results: 23 patients met the inclusion criteria for the study. There was no significant difference between propofol and ketamine in recovery for number recognition between Ketamine (mean difference (MD) = 5.43) and Propofol (MD = 7.43) p= 0.132. There was also no significant difference in recovery for Trieger test between Ketamine (MD=-2.17) and Propofol (MD=-2.96) p = 0.285 (Table 2). There was no significant difference in amnesia for either visual and tactile stimuli testing for both recall and identification (Table 3).

Conclusions: In an outpatient setting medications that provide a rapid recovery time and adequate amnesia are preferable. Other intrinsic reasons should guide the choice between ketamine or propofol (besides surgeon’s preference) as they both show similar recovery times and intra-operative amnesia.

References:
1. Becker DE. Pharmacodynamic considerations for moderate and deep sedation. Anesth Prog. 2012;59(1):28.
2. Kramer KJ, Ganzberg S, Prior S, Rashid RG. Comparison of propofol-remifentanil versus propofol-ketamine deep sedation for third molar surgery. Anesth Prog. 2012;59(3):107-117.
3. Gelfman S, Gracely R, Driscoll E, Wirdzek P, Butler D, Sweet J. Comparison of recovery tests after intravenous sedation with diazepam-methohexital and diazepam-methohexital and fentanyl. Journal of Oral Surgery. 1979;37(6):391-397.

Table 1: Medication Protocol


Table 2: Descriptive Statistics


Table 3: Paired t-test