IV Sedation for Cases of Extended Length Using Either Diazepam With Hydromorphone or Midazolam With Fentanyl

Purpose

In-office IV sedation is an essential part of any Oral and Maxillofacial Surgery practice. The challenge for the practitioner is providing an anesthetic which meets the demands of subject comfort for the entire length of the procedure and provides the practitioner a subject that is as cooperative as possible during surgical intervention. An anesthetic regimen that can provide the subject with a sufficient amount of analgesia, anesthesia, and amnesia with a rapid post-op recovery time is desirable.  A common IV anesthetic technique employed by the University of Iowa OMFS clinics is use of Midazolam and Fentanyl.  Due to the relatively short half-lives of Midazolam and Fentanyl, IV sedation for cases of extended length often requires frequent re-dosing/titration which results in both fluctuation of subject’s anesthetic depth with episodes of insufficient anesthesia and use of large amounts of anesthetic.

This pilot study will attempt to examine an FDA approved IV sedation medication combination of Diazepam and Hydromorphone which are not commonly used but which offers a longer duration of effect and thus may not require as much re-dosing. This would result in a decrease in the overall mount of drug used and provide a more consistent, comfortable sedation for patients. This study will compare and contrast anesthesia for cases of extended length using either the combination of Midazolam with Fentanyl or Diazepam with Hydromorphone.

Patient and Methods

Subjects screened and treatment planned for in-office IV sedation for procedures of forty-five minutes or greater will be randomly assigned to one of two groups. Group A will be administered the anesthetic agents Midazolam and Fentanyl (Combination A). Group B will be administered the anesthetic agents Diazepam and Hydromorphone (Combination B)  At the conclusion of the procedure, in addition to collection of the biometric data, the OMFS and the moderator will fill out a brief intra-operative survey independently which will ascertain their subjective impressions of different aspects of the sedation. In-office post-operative recovery time and analgesic medications used during the immediate post-operative period will be recorded. A post-operative follow-up call the day after surgery and a follow-up appointment 7 days post-operatively will be made and discussion of post-operative course and intraoperative amnesia, anxiolysis, and analgesia with each subject will occur.  Fourteen subjects have been enrolled to date.  A total of 32 subjects will be enrolled into the study.  

Results

Fourteen subjects have been enrolled to date, seven of the fourteen patients (3 female, 4 male) have been administered the anesthetic agents Diazepam and Hydromorphone and seven patients (3 male, 4 female) have been administered the anesthetic agents Midazolam and Fentanyl.  The patients that were administered the combination of Diazepam and Hydromorphone have shown to be adequately sedated for a longer duration with less re-dosing intraoperatively in comparison to the combination of Midazolam and Fentanyl.  The patients that were administered the anesthetic agents Midazolam and Fentanyl required frequent re-dosing/titration to maintain adequate sedation resulting in both the fluctuation of subject’s anesthetic depth and the use of larger amounts of anesthetic.

Conclusion

The results of this study show that the combination of Diazepam and Hydromorphone require less titration with re-dosing providing a more consistent, comfortable sedation for cases of longer duration in comparison to the administration of the anesthetic agents Midazolam and Fentanyl.

References

1. Comparison of various physiologic and psychomotor parameters in patients sedated with intravenous lorazepam, diazepam, or midazolam during oral surgery. van der Bijl P, Roelofse JA, Joubert JJ, van Zyl JF. J Oral Maxillofac Surg. 1991 Jul;49(7):672-8; discussion 678-9.

2. Comparison of nalbuphine and fentanyl in combination with diazepam for outpatient oral surgery. Dolan EA, Murray WJ, Immediata AR, Gleason N. J Oral Maxillofac Surg. 1988 Jun;46(6):471-3.