Retinal DetachmentPhase 4NCT01001429
Dexmedetomidine Versus Propofol in Vitreoretinal Surgery
A Phase 4 study testing Dexmedetomidine infusion and propofol in people with Retinal Detachment, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Dexmedetomidine infusion and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists rating of I-III
- good renal and liver function
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UMDNJ-University Hospital
Newark, New Jersey, 07102
University Hospital
Newark, New Jersey, 07102
About this study
Official title: Comparison of Dexmedetomidine vs. Propofol in Vitreoretinal Surgery Under Sub-Tenon's Block
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.
Read the detailed description
Alpha2 adrenergic receptor agonist have been used increasingly as a new armamentarium to provide sedative/hypnotic, analgesic, anxiolytic and sympatholytic effects in the perioperative settings. Dexmedetomidine, a selective and specific alpha2- adrenoceptor agonist has unique properties that makes it an almost ideal sedative drug for monitored anesthesia care in procedures under local or regional block. Unlike other drugs use for sedation, dexmedetomidine induces sedation that is similar to natural sleep (readily arousable) without causing respiratory depression. It attenuates the stress-induced sympathoadrenal response seen with laryngoscopy and intubation. It has anesthetic and opioid sparing effects, hence it may be a useful adjunct to general anesthesia and monitored anesthesia care in patients susceptible to narcotic induced respiratory depression. Another unique property of dexmedetomidine is that its sedative effect is reversible with Atipamezole. A previous study wherein dexmedetomidine has been used in procedures under local and regional block had shown that it provides effective sedation and better operating condition without significant respiratory depression. As a supplement to general anesthesia, it has been shown to provide stable hemodynamics. However, it is associated with some adverse events such as hypertension, hypotension and bradycardia, these commonly occur during bolus administration of the recommended dose of 1ug/kg. Post-operatively it can cause nausea and vomiting. Vitreoretinal surgery requires either an injection of local anesthetic within the muscle cone (retrobulbar block),or into the periorbital space (peribulbar block). This can be done individually or in combination. This surgery can also be done under a safer technique of retrobulbar block that is given using a sub-tenon's approach through a snip peritomy; a blunt cannula can be used with this technique mitigating the complications of retrobulbar hemorrhage or inadvertent injection into the optic nerve sheath or perforation of the globe using a sharp needle. The anesthetic goal is to provide an immobile and uncongested operative field. Hemodynamic stability of the patient is also important since some patients that require this procedure are elderly with co-morbid conditions such as hypertension, diabetes mellitus and Coronary Artery Disease (CAD). In our study we would like to investigate if Dexmedetomidine alone and in a reduced dose can prevent or reduce the incidence of adverse effects, provide hemodynamic and respiratory stability, provide adequate sedation with patient and surgeon satisfaction and compare it with Propofol.
Objectives:
Primary:
- Adequate sedation
- Hemodynamic and respiratory stability intraoperatively
Secondary:
- surgeon satisfaction
- Time to achieved " street fitness " status
- subject satisfaction
- Hemodynamic stability in PACU
- Conditions
- Retinal Detachment
- Being tested
- Dexmedetomidine infusion, propofol
- Keywords
- sedation for vitreoretinal surgery
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusionDrug
Also called Precedex infusion
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
propofolDrug
Also called Diprivan
propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min Receives: 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. Receives: Drug: Dexmedetomidine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Intraoperative up to 120 min
Secondary outcomes (6)
Time to Achieve "Street Fitness"
Subjects will be kept in the Post Anesthesia Care Unit (PACU) for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge.
Measured: for 2 hours post-operatively in Post Anesthesia Care unit
Surgeon Satisfaction for Adequate Sedation
1=very poor, 2=poor,3=fair, 4=good, 5=excellent
Measured: at 10 minutes into the procedure
Surgeon Satisfaction for Adequate Sedation at Completion of Procedure
surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent
Measured: immediately following the completion of the procedure up to one hour
Patient Satisfaction
1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent
Measured: measured prior to discharge up to 2 hours
Post Operative Hemodynamic Stability
blood pressure documented at 30 minute intervals in PACU up to 120 min
Measured: 2 hours in PACU
Hemodynamic Stability Post Operatively in PACU
heart rate recorded at 30 min intervals in PACU up to 120 min
Measured: PACU to 2 hours post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anuradha Patel, MD, Principal investigator, Rutgers /NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001429
- Sponsor's protocol ID
- 0120090202
- Status last verified
- Apr 2017
- First submitted
- 22 Oct 2009
- Last updated
- 21 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine vs. Propofol in Vitreoretinal Surgery Under Sub-Tenon's Block
- ClinicalTrials.gov ID
- NCT01001429
- Acronym / sponsor ID
- 0120090202
- Conditions
- Retinal Detachment
- Keywords
- sedation for vitreoretinal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Posted 21 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alpha2 adrenergic receptor agonist have been used increasingly as a new armamentarium to provide sedative/hypnotic, analgesic, anxiolytic and sympatholytic effects in the perioperative settings. Dexmedetomidine, a selective and specific alpha2- adrenoceptor agonist has unique properties that makes it an almost ideal sedative drug for monitored anesthesia care in procedures under local or regional block. Unlike other drugs use for sedation, dexmedetomidine induces sedation that is similar to natural sleep (readily arousable) without causing respiratory depression. It attenuates the stress-induced sympathoadrenal response seen with laryngoscopy and intubation. It has anesthetic and opioid sparing effects, hence it may be a useful adjunct to general anesthesia and monitored anesthesia care in patients susceptible to narcotic induced respiratory depression. Another unique property of dexmedetomidine is that its sedative effect is reversible with Atipamezole. A previous study wherein dexmedetomidine has been used in procedures under local and regional block had shown that it provides effective sedation and better operating condition without significant respiratory depression. As a supplement to general anesthesia, it has been shown to provide stable hemodynamics. However, it is associated with some adverse events such as hypertension, hypotension and bradycardia, these commonly occur during bolus administration of the recommended dose of 1ug/kg. Post-operatively it can cause nausea and vomiting. Vitreoretinal surgery requires either an injection of local anesthetic within the muscle cone (retrobulbar block),or into the periorbital space (peribulbar block). This can be done individually or in combination. This surgery can also be done under a safer technique of retrobulbar block that is given using a sub-tenon's approach through a snip peritomy; a blunt cannula can be used with this technique mitigating the complications of retrobulbar hemorrhage or inadvertent injection into the optic nerve sheath or perforation of the globe using a sharp needle. The anesthetic goal is to provide an immobile and uncongested operative field. Hemodynamic stability of the patient is also important since some patients that require this procedure are elderly with co-morbid conditions such as hypertension, diabetes mellitus and Coronary Artery Disease (CAD). In our study we would like to investigate if Dexmedetomidine alone and in a reduced dose can prevent or reduce the incidence of adverse effects, provide hemodynamic and respiratory stability, provide adequate sedation with patient and surgeon satisfaction and compare it with Propofol.
Objectives:
Primary:
- Adequate sedation
- Hemodynamic and respiratory stability intraoperatively
Secondary:
- surgeon satisfaction
- Time to achieved " street fitness " status
- subject satisfaction
- Hemodynamic stability in PACU
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: propofolpropofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min |
| dexmedetomidine infusion | Experimental | Drug: Dexmedetomidine infusionSubject 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists rating of I-III
- good renal and liver function
Key exclusion criteria (8 listed)
- renal and hepatic insufficiency
- uncontrolled diabetes
- uncontrolled hypertension
- severe cardiac disease Class III or IV
- heart blocks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine infusionAlso: Precedex infusionbolus 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 | Drug | dexmedetomidine infusion |
| propofolAlso: Diprivanpropofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min | Drug | Propofol |
Primary outcome
Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)
Time frame: Intraoperative up to 120 min
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 Hemodynamic Stability
Time frame: Intraoperative up to 120 min
systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm
Intraoperative Respiratory Stability
Time frame: Intraoperative up to 120 min
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 Heart Rate Stability
Time frame: Intraoperative up to 120 min
Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm
6 secondary outcomes
Time to Achieve "Street Fitness"
Time frame: for 2 hours post-operatively in Post Anesthesia Care unit
Surgeon Satisfaction for Adequate Sedation
Time frame: at 10 minutes into the procedure
Surgeon Satisfaction for Adequate Sedation at Completion of Procedure
Time frame: immediately following the completion of the procedure up to one hour
Patient Satisfaction
Time frame: measured prior to discharge up to 2 hours
Post Operative Hemodynamic Stability
Time frame: 2 hours in PACU
Hemodynamic Stability Post Operatively in PACU
Time frame: PACU to 2 hours post op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anuradha Patel, MD principal investigator
Rutgers /NJMS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine infusion and propofol in people with Retinal Detachment, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS) (time frame: Intraoperative up to 120 min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.