Clinical Ophthalmology (Jul 2022)
Oral Sedation is Non-Inferior to Intravenous Sedation for Cornea and Glaucoma Surgery: A Randomized Controlled Trial
Abstract
Hyunjoo J Lee, Manishi A Desai, Natalie Sadlak, Marissa G Fiorello, Wanjiku G Githere, Manju L Subramanian, Department of Ophthalmology, Boston Medical Center, Boston, Massachusetts, USA, Department of Anesthesiology, Boston Medical Center, Boston, Massachusetts, USA, Department of Neurology, Boston Medical Center, Boston, Massachusetts, USA, Department of Investigational Pharmacy Services, Boston Medical Center, Boston, Massachusetts, USA, Noelle Crough Babak Eliassi-Rad Elizabeth S. Esparaz Jiwoo Kim Maria Velazquez-Lamela , MD Matthew Leidl Catherine V. Levitt Daniel J. Luther Heenal Marfatia Kambiz Negahban Steven Ness Crandall E. Peeler Tony Pira Rohini Rao Susannah Rowe Nicole H. Siegel Viha Vig, Wissam H. Mustafa Mark C. Norris Pavan Sekhar, Crandall E. Peeler, Stephen Zalewski On behalf of The Oral versus Intravenous Sedation Study GroupDepartment of Ophthalmology, Boston Medical Center, Boston, MA, USACorrespondence: Hyunjoo J Lee, Department of Ophthalmology, Boston Medical Center, 85 East Concord Street, 8th Floor, Boston, MA, 02118, USA, Tel +1 617 414 2020, Fax +1 617 414 2929, Email [email protected]: To determine whether oral sedation is as safe and effective as IV sedation for ophthalmic surgeries other than cataract surgery, we tested whether patient satisfaction with oral triazolam was non-inferior to IV midazolam for cornea and glaucoma surgeries.Patients and Methods: Seventy-five cornea and 49 glaucoma surgery patients 18 years and older at Boston Medical Center (Boston, MA) were randomized within each study group (cornea or glaucoma) to receive oral triazolam + IV placebo, or oral placebo + IV midazolam before surgery in a double-masked fashion. Supplemental IV anesthesia was administered as needed during surgery. The primary outcome measure was patient satisfaction with anesthesia, compared between oral and IV sedation groups via t-test for non-inferiority, based on 70 cornea and 43 glaucoma subjects completing the study. Secondary outcome measures included surgeon and anesthesia provider satisfaction with anesthesia, rate of supplemental IV anesthesia, and incidence of adverse events and surgical complications.Results: Using an a priori non-inferiority margin of 0.5, initial oral sedation was non-inferior to initial IV sedation in cornea (n=70, p< 0.001) and glaucoma (n=43, p=0.017) groups, even after excluding subjects administered supplemental IV anesthesia. There were no significant differences in anesthesia provider or surgeon satisfaction, intra-operative complications, adverse events, or supplemental anesthesia between groups, except for higher anesthesia provider satisfaction with oral sedation in an Ahmed or Baerveldt implant ± cataract surgery sub-group (p=0.04). Subjects receiving supplemental anesthesia included 6 oral (18.2%) and 5 IV (13.5%) in the cornea group (p=0.59), and 7 oral (29.2%) and 6 IV (31.6%) in the glaucoma group (p=0.50).Conclusion: Our results suggest that an initial dose of oral triazolam is equivalent to IV midazolam for non-cataract anterior segment surgeries. However, there was a relatively high need for supplemental IV anesthesia during some surgery types, particularly with glaucoma tube shunt implantation.Keywords: triazolam, midazolam, oral sedation, anesthesia, cornea, glaucoma, ophthalmic surgery
