ShiveringNCT03370562
Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
A study testing Dexmedetomidine in people with Shivering and Nausea and Vomiting, Postoperative, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a randomized double blinded trial to determine if a small dose of dexmedetomidine can prevent and relieve nausea and shivering, two of the more common complaints after cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Shivering, Nausea and Vomiting, Postoperative
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 31 Dec 2020
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective cesarean delivery
- ≥ 18 years of age
- Singleton pregnancy
- Term delivery (37 weeks or greater gestation)
- Spinal or combined spinal-epidural anesthesia is planned
Who cannot join
- Non-elective cesarean delivery
- Receiving misoprostil or carboprost
- Postpartum hemorrhage greater that 1000cc
- Chronic opioid use
- History of chronic nausea or itching in pregnancy
- Receiving medications for nausea
Show all 9Show fewer
- Inability to provide written informed consent
- Receiving of any of the following medications intraoperatively: misoprostil, carboprost, medications for nausea
- Postpartum hemorrhage greater that 1000cc
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
This is a randomized double blinded trial to determine if a small dose of dexmedetomidine can prevent and relieve nausea and shivering, two of the more common complaints after cesarean delivery.
Read the detailed description
This study is a randomized, placebo controlled, double blind evaluation of the use of a single dose of dexmedetomidine for the prevention of shivering and nausea after cesarean delivery. It is hypothesized that patients who receive dexmedetomidine (as compared to placebo) will have a reduced severity of postoperative shivering and nausea.
Study subjects will be have a scheduled cesarean section. They will receive written, informed consent obtained before surgery. After enrollment, patients will receive spinal anesthesia consisting of 11.25mg bupivacaine, 25 mcg of fentanyl, and 250 mcg of morphine. All IV fluid will be warmed.
After delivery of the neonate, delivery of the placenta, and assurance of adequate uterine tone, patients will be randomized in a 1:1 fashion to receive a blinded study syringe consisting of either placebo saline, or 10 mcg of dexmedetomidine.
Study outcomes will be measured on an 11-point Likert scale assessing shivering, nausea, pain, pruritus, and sedation. Assessments will be performed on admission to the recovery room, and at 30 and 60 minutes.
- Conditions
- Shivering, Nausea and Vomiting, Postoperative
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- dexmedetomidine, cesarean, spinal anesthesia
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Administration of 10 mcg intravenous dexmedetomidine
PlaceboDrug
Also called Saline
Administration of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Patient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Patient will receive 5 ml of normal saline, administered by slow intravenous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering measured by Visual analogue score
Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Measured: 60 minutes
Postoperative nausea and vomiting measured by Visual analogue score
Severity of postoperative nausea and vomiting measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Measured: 60 minutes
Secondary outcomes (4)
Pain measured by Visual analogue score
Severity of incisional pain measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Measured: 60 minutes
Pruritus measured by Visual analogue score
Severity of postoperative pruritus measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Measured: 60 minutes
Sedation measured by Visual analogue score
Severity of postoperative sedation measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Measured: 60 minutes
Dry mouth measured by Visual analogue score
Severity of patient complaint of dry mouth measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start18 Feb 2020
- Primary completion20 Mar 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Hess, Beth Israel Deaconess Medical Center
- Investigators
- Philip E Hess, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370562
- Sponsor's protocol ID
- 2017P000517
- Status last verified
- Sep 2021
- First submitted
- 27 Nov 2017
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
- ClinicalTrials.gov ID
- NCT03370562
- Acronym / sponsor ID
- 2017P000517
- Conditions
- Shivering, Nausea and Vomiting, Postoperative
- Keywords
- dexmedetomidine, cesarean, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Dec 2017 (actual)
- 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 is a randomized double blinded trial to determine if a small dose of dexmedetomidine can prevent and relieve nausea and shivering, two of the more common complaints after cesarean delivery.
Detailed description
This study is a randomized, placebo controlled, double blind evaluation of the use of a single dose of dexmedetomidine for the prevention of shivering and nausea after cesarean delivery. It is hypothesized that patients who receive dexmedetomidine (as compared to placebo) will have a reduced severity of postoperative shivering and nausea.
Study subjects will be have a scheduled cesarean section. They will receive written, informed consent obtained before surgery. After enrollment, patients will receive spinal anesthesia consisting of 11.25mg bupivacaine, 25 mcg of fentanyl, and 250 mcg of morphine. All IV fluid will be warmed.
After delivery of the neonate, delivery of the placenta, and assurance of adequate uterine tone, patients will be randomized in a 1:1 fashion to receive a blinded study syringe consisting of either placebo saline, or 10 mcg of dexmedetomidine.
Study outcomes will be measured on an 11-point Likert scale assessing shivering, nausea, pain, pruritus, and sedation. Assessments will be performed on admission to the recovery room, and at 30 and 60 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidinePatient will receive 10 mcg of dexmedetomidine in 5 ml of normal saline, administered by slow intravenous injection |
| Placebo | Placebo comparator | Drug: PlaceboPatient will receive 5 ml of normal saline, administered by slow intravenous injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Elective cesarean delivery
- ≥ 18 years of age
- Singleton pregnancy
- Term delivery (37 weeks or greater gestation)
- Spinal or combined spinal-epidural anesthesia is planned
Key exclusion criteria (9 listed)
- Non-elective cesarean delivery
- Receiving misoprostil or carboprost
- Postpartum hemorrhage greater that 1000cc
- Chronic opioid use
- History of chronic nausea or itching in pregnancy
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexAdministration of 10 mcg intravenous dexmedetomidine | Drug | Dexmedetomidine |
| PlaceboAlso: SalineAdministration of normal saline | Drug | Placebo |
Primary outcome
Shivering measured by Visual analogue score
Time frame: 60 minutes
Severity of patient shivering measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
Postoperative nausea and vomiting measured by Visual analogue score
Time frame: 60 minutes
Severity of postoperative nausea and vomiting measured on a 10-centimeter line with 0 cm representing none and 10 cm representing worst possible
4 secondary outcomes
Pain measured by Visual analogue score
Time frame: 60 minutes
Pruritus measured by Visual analogue score
Time frame: 60 minutes
Sedation measured by Visual analogue score
Time frame: 60 minutes
Dry mouth measured by Visual analogue score
Time frame: 60 minutes
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 1 Oct 2021.
- 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.
Philip E Hess, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Shivering and Nausea and Vomiting, Postoperative, run by Beth Israel Deaconess Medical Center at 1 site 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 5 inclusion and 9 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 1 Oct 2021. 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 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. 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.
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 measured by Visual analogue score (time frame: 60 minutes). 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 1 Oct 2021.