Phase 4
N=77
Dexmedetomidine Versus Propofol in Vitreoretinal Surgery
Retinal Detachment
Bottom Line
View on ClinicalTrials.gov: NCT01001429 ↗Enrolled (actual)
77
Serious AEs
1.3%
Results posted
Aug 2017
Primary outcome: Primary: Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS) — 84.8; 88; .90; .94 units on a scale — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine infusion (Drug); propofol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS) |
84.8; 88; .90; .94 | 0.04 sig |
| PRIMARY Intraoperative Hemodynamic Stability |
124.9; 114.6; 73.6; 66.2 | — |
| PRIMARY Intraoperative Respiratory Stability |
17; 12 | — |
| PRIMARY Intraoperative Heart Rate Stability |
71; 64 | — |
| SECONDARY Time to Achieve "Street Fitness" |
81; 85 | — |
| SECONDARY Surgeon Satisfaction for Adequate Sedation |
4.62; 4.97 | — |
| SECONDARY Surgeon Satisfaction for Adequate Sedation at Completion of Procedure |
4.77; 4.89 | — |
| SECONDARY Patient Satisfaction |
4.61; 4.43 | — |
| SECONDARY Post Operative Hemodynamic Stability |
124.9; 114.6; 73.6; 66.2 | — |
| SECONDARY Hemodynamic Stability Post Operatively in PACU |
74.1; 72 | — |
Summary
The investigators would like to determine if using Dexmedetomidine alone or in a reduced dose can prevent or reduce the incidence of adverse effects, while providing adequate sedation, and respiratory stability as compared to propofol.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists rating of I-III
- good renal and liver function
Exclusion Criteria
- renal and hepatic insufficiency
- uncontrolled diabetes
- uncontrolled hypertension
- severe cardiac disease Class III or IV
- heart blocks
- chronic use of sedatives, narcotics, alcohol or illicit drugs
- allergy to either propofol or dexmedetomidine
- pregnancy or inability to tolerate technique of the study drugs
Data sourced from ClinicalTrials.gov (NCT01001429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.