Dexmedetomidine for Surgical Shivering

Overseen By Hans P Sviggum, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Sedatives

Disqualifiers: Contraindication to spinal anesthesia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Intraoperative

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of Dexmedetomidine to stop shivering in most women undergoing planned cesarean delivery. Dexmedetomidine, administered through an IV, helps manage shivering during surgery. Women in their third trimester with a single baby and no major health issues may qualify. The study excludes those with certain allergies, low pre-surgery temperatures, or those requiring general anesthesia. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have taken sedative medications like fentanyl, midazolam, ketamine, or nitrous oxide before randomization.

What is the safety track record for Dexmedetomidine?

Research has shown that dexmedetomidine is generally safe for people. Studies have found it can effectively reduce shivering after surgeries, such as cesarean sections.

One study found that dexmedetomidine significantly lowered the risk of shivering without increasing side effects. Another study confirmed that dexmedetomidine was more effective at preventing shivering than meperidine.

Safety data from these studies indicate that dexmedetomidine mildly affects heart rate and blood pressure, but these effects are usually manageable. Overall, past research suggests that dexmedetomidine is a safe choice for controlling shivering during surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dexmedetomidine is unique because it specifically targets surgical shivering, a common and uncomfortable side effect during and after surgery. Unlike traditional treatments like meperidine, which is an opioid, dexmedetomidine is a sedative that can reduce shivering without the risk of opioid-related side effects. It works by activating alpha-2 adrenoceptors in the brain, which helps to regulate temperature and reduce shivering. Researchers are excited about dexmedetomidine because it offers a non-opioid alternative with potentially fewer side effects, making it a safer option for patients.

What is the effectiveness track record for Dexmedetomidine in treating surgical shivering?

Research has shown that dexmedetomidine, which participants in this trial will receive, helps reduce shivering after surgery. A review of 39 studies involving 2,478 patients found that dexmedetomidine significantly lowered the chance of shivering compared to a placebo. Another study found that patients who took this medication experienced less shivering around the time of surgery. Additionally, a trial discovered that a certain dose of dexmedetomidine effectively prevented shivering in patients undergoing arthroscopic surgery. Overall, these findings suggest that dexmedetomidine effectively reduces surgery-related shivering. ^{3 6 7 8 9}

Who Is on the Research Team?

Hans Sviggum, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for women having a planned cesarean delivery under spinal anesthesia, with an ASA status of 2 or 3 and no major health issues. They must be in their third trimester without signs of infection or preterm rupture of membranes (PPROM), able to consent, and not have taken certain sedatives or have allergies to dexmedetomidine.

Inclusion Criteria

I will undergo a procedure with spinal anesthesia.

I am having a cesarean delivery and will receive spinal anesthesia.

I am in my third trimester of a single pregnancy.

Exclusion Criteria

I have had premature rupture of membranes or signs of infection in the womb.

Oral temperature < 36° Celsius prior to procedure.

I am unable to give consent on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Pre-operative

1 visit (in-person)

Treatment

Participants receive dexmedetomidine to treat shivering during cesarean delivery

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Immediate post-operative

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine

Trial Overview

The study aims to find the best dose of Dexmedetomidine that stops shivering in 90% of patients during elective cesarean deliveries. It's focused on those who experience shivering as a side effect from the operation.

How Is the Trial Designed?

Group I: Dexmedetomidine Experimental Treatment 1 Intervention

IV administration of Dexmedetomidine, using an Up-Down method utilizing a biased coin design to determine that next patient's dose. Initial dose will be 10mcg.

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Dexmedetomidine at a dose of 0.3 µg/kg was effective in controlling shivering during spinal anesthesia, showing lower cessation times and higher response rates compared to lower doses and meperidine.

While dexmedetomidine 0.3 µg/kg had modest hemodynamic effects, it resulted in lower heart rates and blood pressure, and a higher incidence of sedation, indicating a balance between efficacy and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Abdel-Ghaffar, HS., Mohamed, SA., Fares, KM., et al.[2019]

In a study of 90 female patients undergoing elective abdominal surgery, intraoperative dexmedetomidine infusion significantly reduced the incidence of post-anaesthetic shivering, with only 7 patients experiencing shivering compared to 21 in the saline group (P = 0.001).

Patients receiving dexmedetomidine also had higher sedation scores and lower pain scores in the immediate postoperative period, suggesting that it not only helps prevent shivering but may also enhance overall comfort during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine and postoperative shivering in patients undergoing elective abdominal hysterectomy. Elvan, EG., Oç, B., Uzun, S., et al.[2022]

Dexmedetomidine is the most effective treatment for shivering under spinal anesthesia, controlling it faster (5.7 minutes) and with a lower recurrence rate (3.3%) compared to tramadol (6.76 minutes, 23.3% recurrence) and clonidine (9.43 minutes, 10% recurrence).

While dexmedetomidine has some adverse effects like hypotension and bradycardia, these are manageable, making it a preferable option for treating shivering during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering]. Venkatraman, R., Karthik, K., Pushparani, A., et al.[2022]

Dexmedetomidine significantly reduces postoperative shivering compared to placebo, with a risk ratio of 0.26 based on a meta-analysis of 39 trials involving 2,478 patients.

While dexmedetomidine is effective against shivering, its efficacy is comparable to other common anti-shivering medications, and it may cause side effects like sedation and hypotension, making it less suitable as a sole treatment for this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dexmedetomidine on postoperative shivering: a meta-analysis of clinical trials. Liu, ZX., Xu, FY., Liang, X., et al.[2022]

In a study of 50 patients undergoing spinal anaesthesia, dexmedetomidine was found to be more effective than tramadol in reducing the time taken to stop shivering after surgery.

Dexmedetomidine had fewer adverse effects compared to tramadol, which caused nausea and vomiting in a significant number of patients (28% and 20%, respectively).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. Mittal, G., Gupta, K., Katyal, S., et al.[2022]

In a study of 80 patients undergoing general anesthesia, dexmedetomidine significantly reduced the incidence of postanesthetic shivering to 42.5%, compared to a control group that received saline, indicating its effectiveness in managing this discomfort.

While dexmedetomidine was effective in reducing shivering, it also led to higher rates of sedation and dry mouth, suggesting that while it is beneficial, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in the incidence of shivering with perioperative dexmedetomidine: A randomized prospective study. Bajwa, SJ., Gupta, S., Kaur, J., et al.[2022]

In a study of 80 women undergoing laparoscopic gynecological surgery, dexmedetomidine significantly reduced the incidence of postoperative shivering (12.5% in the dexmedetomidine group vs. 37.5% in the control group).

While dexmedetomidine increased sedation and caused more dry mouth, it also resulted in lower rates of nausea and vomiting compared to the control group, indicating a favorable safety profile for its use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of dexmedetomidine in preventing shivering after general anesthesia for laparoscopic surgery: a randomized, single-blinded, and placebo-controlled trial]. Wu, Y., Huang, H., Zeng, J., et al.[2022]

In a study of 24 children aged 7 to 16 years, a single intravenous dose of dexmedetomidine effectively stopped postanesthesia shivering within 5 minutes, with an average onset of effect at 3.5 minutes.

No adverse effects were reported, indicating that dexmedetomidine is a safe and effective option for managing shivering after anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine for the treatment of postanesthesia shivering in children. Blaine Easley, R., Brady, KM., Tobias, JD.[2022]

In a study of 100 opium users undergoing elective brain tumor surgery, premedication with dexmedetomidine significantly reduced the rates of postoperative nausea and vomiting (PONV) and shivering compared to a placebo group.

The results indicate that dexmedetomidine can be an effective premedication to improve recovery outcomes in patients at risk for these complications, with significant differences observed in both PONV (P=0.001) and shivering (P=0.027).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dexmedetomidine On the Postoperative Shivering, Nausea, and Vomiting Among Opium User Patients Undergoing Elective Supratentorial Brain Tumor Surgery: A Randomized, Placebo, Controlled Clinical trials. Mona, R., Davood, O., Alireza, Z., et al.[2022]

Citations

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A RANDOMIZED CONTROLLED TRIAL

In conclusion, dexmedetomidine infusion significantly reduced shivering during the perioperative period due to its quick start of action, higher ...

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Efficacy of dexmedetomidine on postoperative shivering

Results: Thirty-nine trials with 2,478 patients were included in this meta-analysis. Dexmedetomidine reduced postoperative shivering compared with placebo (risk ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1028455923000220

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The quantitative results of nine RCTs showed that patients who received intravenous dexmedetomidine had a significantly lower risk of postoperative shivering ...

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This study demonstrated that the preventive use of Dex infusion during surgery reduces the frequency and severity of postoperative shivering in ...

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Comparison of three different doses of dexmedetomidine ...

In a previous study, the authors found 0.5 μg/kg of dexmedetomidine effective for prevention of post SA shivering in patients undergoing arthroscopic surgery.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6223340/

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This study showed that intrathecal DEX reduced the risk of shivering in patients undergoing cesarean section after spinal anesthesia and did not increase the ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6035481/

The Effect of Dexmedetomidine Prescription on Shivering ...

The results showed that prescription of dexmedetomidine versus placebo significantly inhibited shivering in patients and decreased the incidence of shivering to ...

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jnacs.com

jnacs.com/article_228019_0c87159f078401a29def140f91e0ba62.pdf

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This study demonstrated that dexmedetomidine is more effective than meperidine in preventing postoperative shivering following lower limb ...

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painphysicianjournal.com/current/pdf?article=MjcwNg%3D%3D&journal=96

Safety and Efficacy of Dexmedetomidine in Treating Post ...

Conclusions: Among the 3 doses investigated, dexmedetomidine 0.3µg/kg effectively treated shivering associated with spinal anesthesia with modest hemodynamic ...