ShiveringPhase 2NCT06711913
Role of Intravenous Dexmedetomidine in Reducing Shivering After Shivering Cesarean Section Due to Spinal Anesthesia
A Phase 2 study testing Dexmedetomidine in people with Shivering, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
"After spinal anesthesia, some patients may experience shivering, which can be uncomfortable and even lead to complications. Dexmedetomidine is a medication that can help prevent or reduce this shivering. Dexmedetomidine helps to: 1. Reduces shivering and discomfort. 2. Improves patient comfort and satisfaction. 3. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shivering
- 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
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Dec 2023to 21 Jun 2024
- Phase
- Phase 2
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective Cesarean section
- Age limit 18 to 35 years
- ASA II
Who cannot join
- Emergency cesarean delivery
- hypersensitive to dexmedetomidine
- Pateint with hear, renal, or hepatic diseases requiring follow up
- Pre-eclemptic pateint
- Patient with GA
- Combined spinal epidural anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intravenous Dexmedetomidine on Shivering After Cesarean Delivery Under Neuraxial Anesthesia - A Randomized Control Trial
"After spinal anesthesia, some patients may experience shivering, which can be uncomfortable and even lead to complications. Dexmedetomidine is a medication that can help prevent or reduce this shivering.
Dexmedetomidine helps to:
- Reduces shivering and discomfort.
- Improves patient comfort and satisfaction.
- Regulates body temperature.
- Safe and effective.
Read the detailed description
Post-spinal shivering is a common complication that occurs in 40-65% of patients undergoing spinal anesthesia. It is characterized by involuntary, rhythmic muscle contractions that can lead to discomfort, anxiety, and increased oxygen consumption.
The exact mechanisms underlying post-spinal shivering are not fully understood, but several factors contribute to its development:
- *Hypothermia*: Spinal anesthesia can cause a decrease in core body temperature, leading to shivering.
- *Sympathetic blockade*: Spinal anesthesia blocks sympathetic nerve fibers, causing vasodilation and decreased blood flow to the extremities.
- *Increased oxygen consumption*: Shivering increases oxygen consumption, which can be detrimental in patients with pre-existing cardiovascular or respiratory disease.
*Effects of Dexmedetomidine on Post-Spinal Shivering*
Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to effectively reduce post-spinal shivering. Its effects include:
- *Decreased shivering intensity*: Dexmedetomidine reduces the severity of shivering, making patients more comfortable.
- *Increased core body temperature*: Dexmedetomidine helps to maintain core body temperature, reducing the likelihood of hypothermia-induced shivering.
- *Reduced oxygen consumption*: By decreasing shivering, dexmedetomidine reduces oxygen consumption, which is beneficial for patients with cardiovascular or respiratory disease.
- *Improved patient comfort*: Dexmedetomidine's sedative and anxiolytic effects contribute to improved patient comfort and satisfaction.
- *Reduced need for other anti-shivering interventions*: Dexmedetomidine's effectiveness in reducing post-spinal shivering may reduce the need for other interventions, such as meperidine, clonidine, or forced-air warming.
Dexmedetomidine's anti-shivering effects are thought to be mediated by its actions on the following mechanisms:
- *Alpha-2 adrenergic receptors*: Dexmedetomidine activates alpha-2 adrenergic receptors, which decreases sympathetic outflow and reduces shivering.
- *Hypothalamic thermoregulation*: Dexmedetomidine may affect the hypothalamus, the body's thermoregulatory center, to reduce shivering and maintain core body temperature.
- *Spinal cord mechanisms*: Dexmedetomidine may also act on the spinal cord to reduce shivering, possibly by inhibiting the release of excitatory neurotransmitters.
- Conditions
- Shivering
- Being tested
- Dexmedetomidine, Normal Saline (Placebo)
- Keywords
- shivering, dexmedetomidine, neuraxial anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
intravenous dexmedetomidine given in form of 100ml infusion over 10 minutes
Normal Saline (Placebo)Other
control group receive normal saline as placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Received intravenous dexmedetomidine Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | control group receive normal saline Receives: Other: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering
Crossley and Mahajan grading of intraoperative shivering Grade 0: no shivering grade 1:no visible muscle activity but piloerection, peripheral vasoconstriction, or both present grade 2: muscular activity in one muscle group grade 3: muscle activity in one than more muscle group
Measured: 3 minutes following infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start21 Dec 2023
- Primary completion15 Jun 2024
- Study completion21 Jun 2024
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghulam Fatima, Liaquat National Hospital & Medical College
- Investigators
- Ghulam Fatima kharl, Principal investigator, Liaquat national hospital and medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711913
- Sponsor's protocol ID
- Liaquat National Hospital 1234
- Other IDs
- Dr ghulam fatima
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Reasons of why individual participant data (IPD) may not be shared: 1. \*Patient confidentiality\*: Sharing IPD could compromise patient confidentiality 2. \*Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns. 3. \*Data storage and security\*: Sharing IPD requires ensuring the security and integrity of the data, which can be a significant technical challenge.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Dexmedetomidine on Shivering After Cesarean Delivery Under Neuraxial Anesthesia - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06711913
- Acronym / sponsor ID
- Liaquat National Hospital 1234
- Conditions
- Shivering
- Keywords
- shivering, dexmedetomidine, neuraxial anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 2 Dec 2024 (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.
"After spinal anesthesia, some patients may experience shivering, which can be uncomfortable and even lead to complications. Dexmedetomidine is a medication that can help prevent or reduce this shivering.
Dexmedetomidine helps to:
- Reduces shivering and discomfort.
- Improves patient comfort and satisfaction.
- Regulates body temperature.
- Safe and effective.
Detailed description
Post-spinal shivering is a common complication that occurs in 40-65% of patients undergoing spinal anesthesia. It is characterized by involuntary, rhythmic muscle contractions that can lead to discomfort, anxiety, and increased oxygen consumption.
The exact mechanisms underlying post-spinal shivering are not fully understood, but several factors contribute to its development:
- *Hypothermia*: Spinal anesthesia can cause a decrease in core body temperature, leading to shivering.
- *Sympathetic blockade*: Spinal anesthesia blocks sympathetic nerve fibers, causing vasodilation and decreased blood flow to the extremities.
- *Increased oxygen consumption*: Shivering increases oxygen consumption, which can be detrimental in patients with pre-existing cardiovascular or respiratory disease.
*Effects of Dexmedetomidine on Post-Spinal Shivering*
Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to effectively reduce post-spinal shivering. Its effects include:
- *Decreased shivering intensity*: Dexmedetomidine reduces the severity of shivering, making patients more comfortable.
- *Increased core body temperature*: Dexmedetomidine helps to maintain core body temperature, reducing the likelihood of hypothermia-induced shivering.
- *Reduced oxygen consumption*: By decreasing shivering, dexmedetomidine reduces oxygen consumption, which is beneficial for patients with cardiovascular or respiratory disease.
- *Improved patient comfort*: Dexmedetomidine's sedative and anxiolytic effects contribute to improved patient comfort and satisfaction.
- *Reduced need for other anti-shivering interventions*: Dexmedetomidine's effectiveness in reducing post-spinal shivering may reduce the need for other interventions, such as meperidine, clonidine, or forced-air warming.
Dexmedetomidine's anti-shivering effects are thought to be mediated by its actions on the following mechanisms:
- *Alpha-2 adrenergic receptors*: Dexmedetomidine activates alpha-2 adrenergic receptors, which decreases sympathetic outflow and reduces shivering.
- *Hypothalamic thermoregulation*: Dexmedetomidine may affect the hypothalamus, the body's thermoregulatory center, to reduce shivering and maintain core body temperature.
- *Spinal cord mechanisms*: Dexmedetomidine may also act on the spinal cord to reduce shivering, possibly by inhibiting the release of excitatory neurotransmitters.
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 |
|---|---|---|
| Intervention group | Active comparator | Drug: DexmedetomidineReceived intravenous dexmedetomidine |
| Control group | Placebo comparator | Other: Normal Saline (Placebo)control group receive normal saline |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elective Cesarean section
- Age limit 18 to 35 years
- ASA II
Key exclusion criteria (6 listed)
- Emergency cesarean delivery
- hypersensitive to dexmedetomidine
- Pateint with hear, renal, or hepatic diseases requiring follow up
- Pre-eclemptic pateint
- Patient with GA
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 |
|---|---|---|
| Dexmedetomidineintravenous dexmedetomidine given in form of 100ml infusion over 10 minutes | Drug | Intervention group |
| Normal Saline (Placebo)control group receive normal saline as placebo | Other | Control group |
Primary outcome
Shivering
Time frame: 3 minutes following infusion
Crossley and Mahajan grading of intraoperative shivering Grade 0: no shivering grade 1:no visible muscle activity but piloerection, peripheral vasoconstriction, or both present grade 2: muscular activity in one muscle group grade 3: muscle activity in one than more muscle group
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 2 Dec 2024.
- Kumar S, Choudhury B, Varikasuvu SR, Singh H, Kumar S, Lahon J, et al. A Systematic Review and Meta-analysis of Efficacy and Safety of Dexmedetomidine Combined With Intrathecal Bupivacaine Compared to Placebo. Cureus. 2022;14(12):e32425.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Reasons of why individual participant data (IPD) may not be shared: 1. *Patient confidentiality*: Sharing IPD could compromise patient confidentiality 2. *Informed consent*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns. 3. *Data storage and security*: Sharing IPD requires ensuring the security and integrity of the data, which can be a significant technical challenge.
Related trials for Shivering
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
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Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
Not yet recruiting
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, Inadvertent Perioperative Hypothermia
Recruiting
Effect Of Acupressure On Hypothermıa And Shıverıng After Cesarean Sectıon
Hypothermia, Shivering
Not yet recruitingPhase 4
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
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.
Ghulam Fatima kharl principal investigator
Liaquat national hospital and medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine in people with Shivering, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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 2 Dec 2024. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (time frame: 3 minutes following infusion). 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 2 Dec 2024.