Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

NCT01001429 | Completed Phase 4 Results

• 1 other identifier: 0120090202
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Retinal Detachment

Keywords

sedation for vitreoretinal surgery

Outcome Measures

Primary Outcomes (4)

• Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)

  Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.

  Intraoperative up to 120 min

• Intraoperative Hemodynamic Stability

  systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm

  Intraoperative up to 120 min

• Intraoperative Respiratory Stability

  respiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm

  Intraoperative up to 120 min

• Intraoperative Heart Rate Stability

  Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm

  Intraoperative up to 120 min

Secondary Outcomes (6)

• Time to Achieve "Street Fitness"

  for 2 hours post-operatively in Post Anesthesia Care unit

• Surgeon Satisfaction for Adequate Sedation

  at 10 minutes into the procedure

• Surgeon Satisfaction for Adequate Sedation at Completion of Procedure

  immediately following the completion of the procedure up to one hour

• Patient Satisfaction

  measured prior to discharge up to 2 hours

• Post Operative Hemodynamic Stability

  2 hours in PACU

Study Arms (2)

Propofol

ACTIVE COMPARATOR

propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min

Drug: propofol

dexmedetomidine infusion

EXPERIMENTAL

Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug.

Drug: Dexmedetomidine infusion

Interventions

Dexmedetomidine infusion DRUG

bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug

Also known as: Precedex infusion

dexmedetomidine infusion

propofol DRUG

propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min

Also known as: Diprivan

Propofol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists rating of I-III
• good renal and liver function

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

UMDNJ-University Hospital

Newark, New Jersey, 07102, United States

Location

University Hospital

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

Retinal Detachment

Interventions

Propofol

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Termination of study due to difficulty recruiting subjects who fit the study criteria.

Results Point of Contact

• Title: Anuradha Patel, MD
• Organization: Rutgers New Jersey Medical School

patelan@njms.rutgers.edu

973 972-1886

Study Officials

• Anuradha Patel, MD

  Rutgers /NJMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 26, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 21, 2017
• Results First Posted: August 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)