Perioperative/Postoperative ComplicationsPhase 4NCT01921361
The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
A Phase 4 study testing Levobupivacaine, Dexmedetomidine and sodium chloride in people with Perioperative/Postoperative Complications, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Levobupivacaine, Dexmedetomidine and sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Jan 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 y/o patients
- American Society of Anesthesiologists' physical status class I-II
- Scheduled for the spinal anesthesia
Who cannot join
- Patients who have the body temperature over 37.3 celsius degree
- Pregnants
- Known allergies to the study drugs
- Contraindication to spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.
Read the detailed description
The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride.
Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received.
Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.
- Being tested
- Levobupivacaine, Dexmedetomidine, sodium chloride
- Keywords
- Shivering, Dexmedetomidine, Spinal anesthesia
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaine, 0.5%, 10 ml, Abbott
Intrathecal 3ml (15 mg)
DexmedetomidineDrug
Also called Precedex, 100 mcg/ml, Abbott
Intrathecal 3 microgram (diluted 1/10, 0.3 ml)
DexmedetomidineDrug
Also called Precedex, 100 mcg/ml, Abbott
Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)
sodium chlorideDrug
Also called 0.9 Sodium chloride
Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous | Active comparator | Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous dexmedetomidine (dexmedetomidine diluted 1mcg/ml and than 1ml/kg/10 minutes and 0.5 ml/kg/hour infusion) Receives: Drug: Levobupivacaine; Drug: Dexmedetomidine; Drug: sodium chloride |
| Intrathecal | Active comparator | Intrathecal (3 ml) 15 mg levobupivacaine + (0.3 ml) 3 mcg dexmedetomidine (dexmedetomidine diluted 10 mcg/ml) and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion) Receives: Drug: Levobupivacaine; Drug: Dexmedetomidine; Drug: sodium chloride |
| Control | Placebo comparator | Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion). Receives: Drug: Levobupivacaine; Drug: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
shivering score
Measured: 1 day (From start of anaesthesia till discharge from the recovery room )
Secondary outcomes (3)
blood pressure
non invasive blood pressure measured
Measured: 1 day (From start of anaesthesia till discharge from the recovery room )
heart rate
Measured: 1 day (From start of anaesthesia till discharge from the recovery room )
core temperature
lower than 36 celsius degree was accepted as hypothermia
Measured: 1 day (From start of anaesthesia till discharge from the recovery room )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RESUL ALTUNTAS, TC Erciyes University
- Investigators
- Resul Altuntas, MD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921361
- Sponsor's protocol ID
- B.30.2.ERC.0.01.00.01/27
- Status last verified
- Aug 2013
- First submitted
- 3 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine on Peroperative Shivering Incidence Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01921361
- Acronym / sponsor ID
- B.30.2.ERC.0.01.00.01/27
- Keywords
- Shivering, Dexmedetomidine, Spinal anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Aug 2013 (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.
The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.
Detailed description
The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride.
Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received.
Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous | Active comparator | Drug: Levobupivacaine, Drug: Dexmedetomidine, Drug: sodium chlorideIntrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous dexmedetomidine (dexmedetomidine diluted 1mcg/ml and than 1ml/kg/10 minutes and 0.5 ml/kg/hour infusion) |
| Intrathecal | Active comparator | Drug: Levobupivacaine, Drug: Dexmedetomidine, Drug: sodium chlorideIntrathecal (3 ml) 15 mg levobupivacaine + (0.3 ml) 3 mcg dexmedetomidine (dexmedetomidine diluted 10 mcg/ml) and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion) |
| Control | Placebo comparator | Drug: Levobupivacaine, Drug: sodium chlorideIntrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 y/o patients
- American Society of Anesthesiologists' physical status class I-II
- Scheduled for the spinal anesthesia
Key exclusion criteria (4 listed)
- Patients who have the body temperature over 37.3 celsius degree
- Pregnants
- Known allergies to the study drugs
- Contraindication to spinal anesthesia
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 |
|---|---|---|
| LevobupivacaineAlso: Chirocaine, 0.5%, 10 ml, AbbottIntrathecal 3ml (15 mg) | Drug | Control, Intrathecal, Intravenous |
| DexmedetomidineAlso: Precedex, 100 mcg/ml, AbbottIntrathecal 3 microgram (diluted 1/10, 0.3 ml) | Drug | Intravenous |
| DexmedetomidineAlso: Precedex, 100 mcg/ml, AbbottIntravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml) | Drug | Intrathecal |
| sodium chlorideAlso: 0.9 Sodium chlorideIntravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups. | Drug | Control, Intrathecal, Intravenous |
Primary outcome
shivering score
Time frame: 1 day (From start of anaesthesia till discharge from the recovery room )
3 secondary outcomes
blood pressure
Time frame: 1 day (From start of anaesthesia till discharge from the recovery room )
heart rate
Time frame: 1 day (From start of anaesthesia till discharge from the recovery room )
core temperature
Time frame: 1 day (From start of anaesthesia till discharge from the recovery room )
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 13 Aug 2013.
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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.
Resul Altuntas, MD principal investigator
TC Erciyes University
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 Levobupivacaine, Dexmedetomidine and sodium chloride in people with Perioperative/Postoperative Complications, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 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 13 Aug 2013. 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 Turkey (Türkiye). 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?
shivering score (time frame: 1 day (From start of anaesthesia till discharge from the recovery room )). 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 13 Aug 2013.