Failed Moderate Sedation During ProcedurePhase 4NCT02878837
Dexmedetomidine vs Midazolam for Intraoperative Sedation
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Failed Moderate Sedation During Procedure and Minimally Conscious State, run by Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo at 1 site in Brazil.
Trial summary
This randomized, open clinical trial sought to compare the use of Midazolam and Dexmedetomidine during surgery in patients under regional anesthesia. The primary objective was to determine the superiority of either drug during the intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Moderate Sedation During Procedure, Minimally Conscious State
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing surgery under regional anesthesia
Who cannot join
- The presence of any Bradyarrhythmia;
- New York Heart Association (NYHA) Functional Classes III and IV Heart Failure and/or Left Ventricle Ejection Fraction under 30%;
- Respiratory Failure, Glasgow Coma Scale score 8 or under, and Liver Failure - due to the increased risk of sedation in patients with these conditions (d) refusal to participate in the study or withdrawal of consent at any moment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital do Servidor Publico Estadual
São Paulo, Sao Paulo SP, 04039-901
About this study
Official title: Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation
This randomized, open clinical trial sought to compare the use of Midazolam and Dexmedetomidine during surgery in patients under regional anesthesia.
The primary objective was to determine the superiority of either drug during the intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications.
Secondary objectives included the determination of superiority regarding the postoperative period.
For that, patients were randomized into two groups and sedated with either Midazolam or Dexmedetomidine.
Read the detailed description
This study was a randomized, open clinical trial.
Patients undergoing surgery under regional (neuraxial or brachial plexus block) anesthesia were randomly assigned into one of two groups.
Patients in one of the groups (called MDZ) were initially sedated with a 0.05mg/Kg bolus dose of Midazolam.
The ones in the other group (called DEX) were initially sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes, followed by continuous infusion at 0.2 to 0.8 µg/Kg/h.
In order to achieve a Richmond Agitation-Sedation Scale (RASS) score between -3 and -1, the following breakthrough doses were used as necessary:
MDZ: 0.02 mg/Kg bolus dose of Midazolam plus 0.5µg/Kg bolus dose of Fentanyl DEX: 0.5µg/Kg bolus dose of Fentanyl
Depth of sedation and incidence of complications were recorded during surgery, in the Post Anesthesia Care Unit (PACU) and in the Ward for two days following surgery,
- Being tested
- Dexmedetomidine, Midazolam
- Medical subject headings
- Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
MidazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| DEX | Active comparator | Patients undergoing surgical procedures under regional anesthesia sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes followed by continuous infusion at 0.2 to 0.8 µg/Kg/h, along with 0.5µg/Kg bolus breakthrough doses of Fentanyl as necessary to achieve a RASS score between -3 and -1. Receives: Drug: Dexmedetomidine |
| MDZ | Active comparator | Patients undergoing surgical procedures under regional anesthesia sedated with a 0.05mg/Kg bolus dose of Midazolam, along with 0.02 mg/Kg bolus doses of Midazolam plus 0.5µg/Kg bolus doses of Fentanyl as necessary to achieve a RASS score between -3 and -1 Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of Sedation
Number of breakthrough doses necessary to achieve RASS score between -3 and -1
Measured: Intraoperative
Respiratory depression
Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation
Measured: Intraoperative
Bradycardia
Heart Rate < 50 heartbeats per minute
Measured: Intraoperative
Hypotension
Mean Arterial Pressure < 55mmHg
Measured: Intraoperative
Secondary outcomes (6)
Residual Sedation
RASS score < -1 in Post Anesthesia Care Unit
Measured: Up to 2 hours after surgery
Shivering
Self-described by the patient
Measured: Up to 2 hours after end of surgery
Pain
Pain, described by the patient, according to the Analog Scale. Necessity of breakthrough doses of analgesics.
Measured: 2 days
Quality of Sleep
Self-described.
Measured: 2 days
Delirium
Incidence of Delirium according to CAM-ICU algorithm
Measured: 2 days
Length of Hospital Stay
Length of time between surgery and discharge from Hospital, in days
Measured: Until Discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Failed Moderate Sedation During ProcedureStudies 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João manoel Silva Junior, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878837
- Sponsor's protocol ID
- IAMSPE
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ostermann ME, Keenan SP, Seiferling RA, Sibbald WJ. Sedation in the intensive care unit: a systematic review. JAMA. 2000 Mar 15;283(11):1451-9. doi: 10.1001/jama.283.11.1451.
PubMed 10732935Bailey PL, Pace NL, Ashburn MA, Moll JW, East KA, Stanley TH. Frequent hypoxemia and apnea after sedation with midazolam and fentanyl. Anesthesiology. 1990 Nov;73(5):826-30. doi: 10.1097/00000542-199011000-00005.
PubMed 2122773American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. 2002 Apr;96(4):1004-17. doi: 10.1097/00000542-200204000-00031. No abstract available.
PubMed 11964611Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
PubMed 19713256Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.
PubMed 10702460Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000 Aug;93(2):382-94. doi: 10.1097/00000542-200008000-00016.
PubMed 10910487Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care. 2000;4(5):302-8. doi: 10.1186/cc712. Epub 2000 Jul 31.
PubMed 11056756Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. doi: 10.1097/00000539-200208000-00042.
PubMed 12145072Venn RM, Grounds RM. Comparison between dexmedetomidine and propofol for sedation in the intensive care unit: patient and clinician perceptions. Br J Anaesth. 2001 Nov;87(5):684-90. doi: 10.1093/bja/87.5.684.
PubMed 11878517Elbaradie S, El Mahalawy FH, Solyman AH. Dexmedetomidine vs. propofol for short-term sedation of postoperative mechanically ventilated patients. J Egypt Natl Canc Inst. 2004 Sep;16(3):153-8.
PubMed 15959548Abdalla MI, Al Mansouri F, Bener A. Dexmedetomidine during local anesthesia. J Anesth. 2006;20(1):54-6. doi: 10.1007/s00540-005-0351-z.
PubMed 16421680Taghinia AH, Shapiro FE, Slavin SA. Dexmedetomidine in aesthetic facial surgery: improving anesthetic safety and efficacy. Plast Reconstr Surg. 2008 Jan;121(1):269-276. doi: 10.1097/01.prs.0000293867.05857.90.
PubMed 18176230Usta B, Gozdemir M, Demircioglu RI, Muslu B, Sert H, Yaldiz A. Dexmedetomidine for the prevention of shivering during spinal anesthesia. Clinics (Sao Paulo). 2011;66(7):1187-91. doi: 10.1590/s1807-59322011000700011.
PubMed 21876972Bajwa SJ, Gupta S, Kaur J, Singh A, Parmar S. Reduction in the incidence of shivering with perioperative dexmedetomidine: A randomized prospective study. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):86-91. doi: 10.4103/0970-9185.92452.
PubMed 22345953Belleville JP, Ward DS, Bloor BC, Maze M. Effects of intravenous dexmedetomidine in humans. I. Sedation, ventilation, and metabolic rate. Anesthesiology. 1992 Dec;77(6):1125-33. doi: 10.1097/00000542-199212000-00013.
PubMed 1361310
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation
- ClinicalTrials.gov ID
- NCT02878837
- Acronym / sponsor ID
- IAMSPE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao PauloUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, open clinical trial sought to compare the use of Midazolam and Dexmedetomidine during surgery in patients under regional anesthesia.
The primary objective was to determine the superiority of either drug during the intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications.
Secondary objectives included the determination of superiority regarding the postoperative period.
For that, patients were randomized into two groups and sedated with either Midazolam or Dexmedetomidine.
Detailed description
This study was a randomized, open clinical trial.
Patients undergoing surgery under regional (neuraxial or brachial plexus block) anesthesia were randomly assigned into one of two groups.
Patients in one of the groups (called MDZ) were initially sedated with a 0.05mg/Kg bolus dose of Midazolam.
The ones in the other group (called DEX) were initially sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes, followed by continuous infusion at 0.2 to 0.8 µg/Kg/h.
In order to achieve a Richmond Agitation-Sedation Scale (RASS) score between -3 and -1, the following breakthrough doses were used as necessary:
MDZ: 0.02 mg/Kg bolus dose of Midazolam plus 0.5µg/Kg bolus dose of Fentanyl DEX: 0.5µg/Kg bolus dose of Fentanyl
Depth of sedation and incidence of complications were recorded during surgery, in the Post Anesthesia Care Unit (PACU) and in the Ward for two days following surgery,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX | Active comparator | Drug: DexmedetomidinePatients undergoing surgical procedures under regional anesthesia sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes followed by continuous infusion at 0.2 to 0.8 µg/Kg/h, along with 0.5µg/Kg bolus breakthrough doses of Fentanyl as necessary to achieve a RASS score between -3 and -1. |
| MDZ | Active comparator | Drug: MidazolamPatients undergoing surgical procedures under regional anesthesia sedated with a 0.05mg/Kg bolus dose of Midazolam, along with 0.02 mg/Kg bolus doses of Midazolam plus 0.5µg/Kg bolus doses of Fentanyl as necessary to achieve a RASS score between -3 and -1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing surgery under regional anesthesia
Key exclusion criteria (3 listed)
- The presence of any Bradyarrhythmia;
- New York Heart Association (NYHA) Functional Classes III and IV Heart Failure and/or Left Ventricle Ejection Fraction under 30%;
- Respiratory Failure, Glasgow Coma Scale score 8 or under, and Liver Failure - due to the increased risk of sedation in patients with these conditions (d) refusal to participate in the study or withdrawal of consent at any moment.
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 | Drug | DEX |
| Midazolam | Drug | MDZ |
Primary outcome
Depth of Sedation
Time frame: Intraoperative
Number of breakthrough doses necessary to achieve RASS score between -3 and -1
Respiratory depression
Time frame: Intraoperative
Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation
Bradycardia
Time frame: Intraoperative
Heart Rate < 50 heartbeats per minute
Hypotension
Time frame: Intraoperative
Mean Arterial Pressure < 55mmHg
6 secondary outcomes
Residual Sedation
Time frame: Up to 2 hours after surgery
Shivering
Time frame: Up to 2 hours after end of surgery
Pain
Time frame: 2 days
Quality of Sleep
Time frame: 2 days
Delirium
Time frame: 2 days
Length of Hospital Stay
Time frame: Until Discharge, up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Background: PubMed 10732935Ostermann ME, Keenan SP, Seiferling RA, Sibbald WJ. Sedation in the intensive care unit: a systematic review. JAMA. 2000 Mar 15;283(11):1451-9. doi: 10.1001/jama.283.11.1451.
- Background: PubMed 2122773Bailey PL, Pace NL, Ashburn MA, Moll JW, East KA, Stanley TH. Frequent hypoxemia and apnea after sedation with midazolam and fentanyl. Anesthesiology. 1990 Nov;73(5):826-30. doi: 10.1097/00000542-199011000-00005.
- Background: PubMed 11964611American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. 2002 Apr;96(4):1004-17. doi: 10.1097/00000542-200204000-00031. No abstract available.
- Background: PubMed 19713256Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
- Background: PubMed 10702460Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.
- Background: PubMed 10910487Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000 Aug;93(2):382-94. doi: 10.1097/00000542-200008000-00016.
- Background: PubMed 11056756Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care. 2000;4(5):302-8. doi: 10.1186/cc712. Epub 2000 Jul 31.
- Background: PubMed 12145072Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. doi: 10.1097/00000539-200208000-00042.
- Background: PubMed 11878517Venn RM, Grounds RM. Comparison between dexmedetomidine and propofol for sedation in the intensive care unit: patient and clinician perceptions. Br J Anaesth. 2001 Nov;87(5):684-90. doi: 10.1093/bja/87.5.684.
- Background: PubMed 15959548Elbaradie S, El Mahalawy FH, Solyman AH. Dexmedetomidine vs. propofol for short-term sedation of postoperative mechanically ventilated patients. J Egypt Natl Canc Inst. 2004 Sep;16(3):153-8.
- Background: PubMed 16421680Abdalla MI, Al Mansouri F, Bener A. Dexmedetomidine during local anesthesia. J Anesth. 2006;20(1):54-6. doi: 10.1007/s00540-005-0351-z.
- Background: PubMed 18176230Taghinia AH, Shapiro FE, Slavin SA. Dexmedetomidine in aesthetic facial surgery: improving anesthetic safety and efficacy. Plast Reconstr Surg. 2008 Jan;121(1):269-276. doi: 10.1097/01.prs.0000293867.05857.90.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Midazolam in people with Failed Moderate Sedation During Procedure and Minimally Conscious State, run by Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo at 1 site in Brazil.
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 1 inclusion and 3 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 22 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 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depth of Sedation (time frame: Intraoperative). 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?
On the ClinicalTrials.gov record for NCT02878837, which also lists 27 linked publications.
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 22 Aug 2017.