Anesthesia RecoveryPhase 4NCT02141412
Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia
A Phase 4 study testing dexmedetomidine 0.25 µg/kg IV, dexmedetomidine 0.5 µg/kg IV and dexmedetomidine 1 µg/kg IV in people with Anesthesia Recovery and Anesthesia Emergence, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia Recovery, Anesthesia Emergence, Shivering
- What is being tested?
- dexmedetomidine 0.25 µg/kg IV, dexmedetomidine 0.5 µg/kg IV and dexmedetomidine 1 µg/kg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteLebanon
- Study dates
- Sep 2009to Sep 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 year-old
- ASA class I, II, and III
- patients undergoing elective surgery under general anesthesia with an estimated time of 1-3 h
Who cannot join
- duration of surgery less than 1h or more than 3 h
- allergy to dexmedetomidine
- vasoactive antidepressant or analgesics
- obesity (BMI>30)
- fever
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study
In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo.
Read the detailed description
Patients undergoing surgery under general anesthesia may experience several complications during the postoperative period. Shivering has been reported to occur in up to 65% of patients recovering from general anesthesia, and has been shown to cause detrimental effects to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery significantly reduces the incidence of postoperative shivering and improves quality of emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the expense of prolonged time to extubation and awakening. The aim of this study is to find the optimal dose of dexmedetomidine that would be beneficial without delaying recovery from general anesthesia.
- Being tested
- dexmedetomidine 0.25 µg/kg IV, dexmedetomidine 0.5 µg/kg IV, dexmedetomidine 1 µg/kg IV, Placebo Comparator
- Keywords
- optimal dose of dexmedetomidine, prevent shivering, improve quality of emergence, anesthesia, without delay, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine 0.25 µg/kg IVDrug
dexmedetomidine 0.5 µg/kg IVDrug
dexmedetomidine 1 µg/kg IVDrug
Placebo ComparatorDrug
Patients in Group IV will receive same volume of normal saline at closure of sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane Receives: Drug: dexmedetomidine 0.25 µg/kg IV |
| Group II | Active comparator | Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane Receives: Drug: dexmedetomidine 0.5 µg/kg IV |
| Group III | Active comparator | Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane Receives: Drug: dexmedetomidine 1 µg/kg IV |
| Group IV | Placebo comparator | Patients in Group IV will receive same volume of normal saline at closure of sevoflurane Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postanaesthetic shivering incidence and score
Measured: change from baseline every 10 minutes up to 1 hour post-operatively
Quality of emergence from anesthesia
The anesthesiologist blinded to the group allocation will assess patients for coughing, hypertension, tachycardia, limb movement during extubation
Measured: Change from baseline every 5 minutes till extubation
Secondary outcomes (5)
Patient's Temperature
Measured: every 10 minutes up to 1 hour post-operatively
Time to extubation, awakening and orientation
Measured: 1 hour post-operatively
Sedation scores
Measured: every 10 minutes up to 1 hour post-operatively
Pain scores
Measured: every 10 minutes up to 1 hour post-operatively
Nausea and vomiting
Measured: every 10 minutes up to 1 hour post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startSep 2009
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia RecoveryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marie Awad, American University of Beirut Medical Center
- Investigators
- Marie Aouad, MD, Principal investigator, American Univesity of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141412
- Sponsor's protocol ID
- ANES.MA.10
- Status last verified
- Jun 2018
- First submitted
- 15 May 2014
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study
- ClinicalTrials.gov ID
- NCT02141412
- Acronym / sponsor ID
- ANES.MA.10
- Keywords
- optimal dose of dexmedetomidine, prevent shivering, improve quality of emergence, anesthesia, without delay, recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 May 2014 (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.
In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo.
Detailed description
Patients undergoing surgery under general anesthesia may experience several complications during the postoperative period. Shivering has been reported to occur in up to 65% of patients recovering from general anesthesia, and has been shown to cause detrimental effects to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery significantly reduces the incidence of postoperative shivering and improves quality of emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the expense of prolonged time to extubation and awakening. The aim of this study is to find the optimal dose of dexmedetomidine that would be beneficial without delaying recovery from general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: dexmedetomidine 0.25 µg/kg IVPatients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane |
| Group II | Active comparator | Drug: dexmedetomidine 0.5 µg/kg IVPatients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane |
| Group III | Active comparator | Drug: dexmedetomidine 1 µg/kg IVPatients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane |
| Group IV | Placebo comparator | Drug: Placebo ComparatorPatients in Group IV will receive same volume of normal saline at closure of sevoflurane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 year-old
- ASA class I, II, and III
- patients undergoing elective surgery under general anesthesia with an estimated time of 1-3 h
Key exclusion criteria (6 listed)
- duration of surgery less than 1h or more than 3 h
- allergy to dexmedetomidine
- vasoactive antidepressant or analgesics
- obesity (BMI>30)
- fever
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 0.25 µg/kg IV | Drug | Group I |
| dexmedetomidine 0.5 µg/kg IV | Drug | Group II |
| dexmedetomidine 1 µg/kg IV | Drug | Group III |
| Placebo ComparatorPatients in Group IV will receive same volume of normal saline at closure of sevoflurane | Drug | Group IV |
Primary outcome
Postanaesthetic shivering incidence and score
Time frame: change from baseline every 10 minutes up to 1 hour post-operatively
Quality of emergence from anesthesia
Time frame: Change from baseline every 5 minutes till extubation
The anesthesiologist blinded to the group allocation will assess patients for coughing, hypertension, tachycardia, limb movement during extubation
5 secondary outcomes
Patient's Temperature
Time frame: every 10 minutes up to 1 hour post-operatively
Time to extubation, awakening and orientation
Time frame: 1 hour post-operatively
Sedation scores
Time frame: every 10 minutes up to 1 hour post-operatively
Pain scores
Time frame: every 10 minutes up to 1 hour post-operatively
Nausea and vomiting
Time frame: every 10 minutes up to 1 hour post-operatively
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 27 Jun 2018.
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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.
Marie Aouad, MD principal investigator
American Univesity of Beirut Medical Center
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 0.25 µg/kg IV, dexmedetomidine 0.5 µg/kg IV and dexmedetomidine 1 µg/kg IV in people with Anesthesia Recovery and Anesthesia Emergence, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 3 inclusion and 6 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 27 Jun 2018. 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 Lebanon. 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. Some participants in this study may receive a placebo. 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?
Postanaesthetic shivering incidence and score (time frame: change from baseline every 10 minutes up to 1 hour post-operatively). The study lists 2 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 27 Jun 2018.